Explore each of the 8 competency domains below to identify the knowledge, skills, and attitudes necessary for the effective, ethical, and safe conduct of clinical trials. The domains are based on the internationally recognised Joint Task Force for Clinical Trial Competency (JTF) framework and have been adapted to Swiss legislation on human research.
Fundamental, skilled, and advanced levels correspond to sub-investigator, investigator and sponsor-investigator roles respectively, as defined by ICH-GCP guidelines and Swiss legislation on human research.
1 — Scientific concepts and research design
Encompasses the knowledge of scientific concepts related to the design and analysis of clinical trials
A1. Have sufficient medical and clinical knowledge in the medical area in which one will support clinical trials
B1. Be an expert for all health-related aspects in the medical area in which one will conduct clinical trials
C1. Be an expert and solid reference for the team for all health-related questions in the medical area in which one will conduct clinical trials
A1. Recognise the need to apply scientific principles to the discovery and development of health-related interventions
A2. Explain the basic scientific principles that should be applied during the development of health-related interventions
Example: When reviewing a clinical research protocol, researcher is able to describe the scientific techniques and principles that lead to the development of the health-related intervention in its current state.
B1. Apply scientific principles when implementing a clinical trial
B2. Implement data collection according to scientific principles and based on protocol design
B3. Critically review the research that builds the basis for the development of health-related interventions
Example: When given a clinical research protocol, researcher is able to critically review the trials that lead to the development of the health-related intervention and is able to critically review the evidence that is the basis for the protocol.
C1. Plan clinical trials according to scientific principles
C2. Develop a data management plan according to scientific principles
Example: When given a clinical trial protocol and the data collected, researcher is able to evaluate the findings and results according to scientific principles.
A1. Articulate different purposes and objectives of clinical trials
A2. Describe the importance of different types of clinical trials for the (clinical) development of health-related interventions
A3. Understand the different elements that must be covered in a trial protocol, including the specific requirements (e.g. regulatory and ethical) linked to the trial type and/or setting
Example: Researcher identifies the following elements in selected trial protocols: trial title, the key purpose and objectives of the trial, why it is important to conduct this trial, who the beneficiaries are, primary and secondary outcomes of the trial, and how outcomes help to meet the objectives.
B1. Know advantages and disadvantages of different types of endpoints/outcomes that are typically used in clinical trials
B2. Identify the research hypothesis in a trial protocol
B3. Identify endpoints (primary and secondary) that will be used in data analyses to measure outcomes
B4. Contribute to relevant sections of a protocol
Example: When given a trial protocol, researcher is able to describe and classify the objectives and associated safety and efficacy endpoints that will be used to test the hypothesis and identify assessments (clinical, social/behavioural, or economic) that will be used to measure endpoints.
C1. Develop a protocol or source document checklist that identifies the scientific questions (hypotheses, PICO (population, intervention, comparison, outcome) structure), primary objectives, secondary objectives, associated endpoints/outcomes, and specific measures/assessments
C2. Define parameters for collecting data on endpoints with objectives
C3. Identify clinically important and relevant evidence gaps and apply the outcome of systematic literature reviews to refine a meaningful and verifiable research question
C4. Coordinate protocol writing and review; track inconsistencies, errors, or omissions
C5. Design an appropriate clinical trial, including selecting a design for the research question, defining outcome measures and endpoints, performing power calculations, estimating realistic recruitment rates, and designing a randomisation and blinding system
Example: Researcher develops presentations to educate others on the scientific feasibility and conduct of the trial to ensure quality collection of endpoints for hypothesis testing.
A1. Recognise the eligibility criteria for trial participants (e.g. that include and exclude participants) based on factors such as age, gender, type and stage of a disease, treatment history, and other medical conditions that allows the research team to determine whether the participants can take part in the trial safely
Example: Researcher identifies the eligibility criteria from a set of sample cases for an upcoming clinical trial.
B1. Articulate the necessity for a homogeneous population (based on criteria defined in the protocol) and the need for consistency in protocol recruitment
B2. Describe the implications of deviations from inclusion/exclusion criteria on data quality and trial validity and how results can be generalised to the public
B3. Develop trial materials (e.g. guidance documents, recruitment plans) to ensure appropriate application of eligibility criteria
B4. Determine the potential eligibility of trial participants for complex trials (e.g. interventional)
Example: During a trial audit, researcher identifies deviations from eligibility guidelines, describes potential consequences, and discusses the required next steps.
C1. Develop and edit eligibility criteria for new protocol development
C2. Explain the rationale for choosing eligibility criteria based on evidence or previous experience
C3. Advise and supervise the correct application of eligibility criteria
Example: Researcher performs an eligibility risk-assessment and risk-mitigation plan for a new clinical trial and monitors screening and enrolment with corrective and preventive action strategies for deviations found.
A1. Recognise the basic differences between the various types of clinical trials
A2. Identify the key elements of a clinical trial protocol
A3. Adhere to a clinical trial protocol to ensure validity of the trial
Example: When given a clinical trial protocol, researcher identifies the trial type and key elements of the protocol and can adhere to them.
B1. Review a clinical trial protocol to ensure all needed elements are included
B2. Understand (design) aspects of a clinical trial that are critical to answer the scientific question(s)
B3. Evaluate strengths and weaknesses of trial designs and explain these to others
B4. Understand the importance of and methods for accessing, critiquing and synthesising literature appropriately
Example: When given a clinical trial protocol, researcher identifies missing, incomplete, or inappropriate features and aspects that are of relevance for conducting the trial and are critical for the objectives.
C1. Evaluate the clinical trial design and communicate it to others
Example: When given a clinical trial protocol that has misalignment between the measures and objectives, researcher appropriately modifies the protocol.
A1. Identify the trial results
A2. Describe the relevance of the results to the research question
Example: When given trial reports, researcher is able to paraphrase and summarise trial results.
B1. Compare and assess the level of quality of results associated with trial reports and publications
B2. Understand the most common descriptive and exploratory data analysis
Example: When given two publications researching the same topic, researcher compares and contrasts what could have affected how the data from both publications could be interpreted.
C1. Communicate trial results to others and interpret them in relation to trial design, conduct, medical context, and practice
Example: When given a trial report, researcher is able to prepare a presentation in which results are critically assessed and presented to others.
2 — Ethics and participant rights
Encompasses the care of patients, their rights, and aspects of participant protection in the conduct of a clinical trial
A1. Identify the key documents that build the foundation of clinical research regulations and know the national laws that regulate clinical research and ensure the protection of human participants, namely:
- Nuremberg code
- Declarations of Helsinki and Taipei
- Belmont Report
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice E6(R2) (ICH-GCP)
- Clinical Investigation of Medical Devices for Human Subjects - Good clinical practice (ISO 14155:2020)
- Swiss Human Research Act (HRA) and associated ordinances
Example: Researcher identifies and explains the three principles of the Belmont Report. Researcher explains the division of responsibilities as defined in Good Clinical Practice (GCP) guidelines.
B1. Comply with and apply the principles, general provisions, and requirements regarding research with humans as set forth in the Swiss Constitution and Swiss Human Research Act
Example: Researcher explains the principles as set forth in chapters 1 and 2 of the Swiss Human Research Act (i.e. originally from Art. 118b of the Swiss Constitution).
C1. Be an expert and solid reference for the team on regulatory aspects related to the conduct of a clinical trial
Example: Researcher supervises and ensures the regulatory compliance of the whole team when conducting a clinical trial.
A1. Explain that a clinical trial is research and not accepted standard of care
Example: Researcher explains to a trial participant which procedures are part of the protocol and are not necessarily standard of care.
B1. Identify clinical trial activities as per protocol that are not standard of care
Example: Researcher explains to clinical staff the timing of a research blood draw versus standard blood draw timing or procedures/assessments that deviate from the standard.
C1. Develop a protocol that appropriately includes distinct clinical trial activities and standards of care
Example: Researcher distinguishes between activities that should be billed to insurance versus those incorporated into sponsored cost.
A1. Recognise that clinical equipoise, uncertainty, and therapeutic misconception are fundamental ethical principles and concerns that underlie clinical research.
Example: Researcher identifies and discusses the two comparators in a controlled clinical trial and why each was selected.
B1. Explain the concept and rationale of clinical equipoise, uncertainty, and therapeutic misconception; demonstrate comprehensive knowledge and understanding of how they may impact a trial participant’s understanding of the trial
B2. Identify how therapeutic misconception might impact the conduct of a trial and consistently apply knowledge of the concept of therapeutic misconception during the course of the trial
B3. Recognise, interpret, and seek assistance where required to address trial participants' concerns regarding clinical equipoise
Example: Researcher identifies during informed the consent process whether a potential participant truly understands the trial is a research project and does not have a predictable outcome.
C1. Act as an expert resource to potential trial participants and staff in their understanding of clinical equipoise
C2. Identify how therapeutic misconception might impact the conduct of a trial and take appropriate action to ensure appropriate conduct of the trial
Example: Researcher leads the development of an in-service training session by interpreting trial protocols in relation to clinical equipoise, the uncertainty principle, and therapeutic misconception.
A1. Comply with global guidelines and recommendations as well as local regulations regarding the rights of all trial participants in a clinical trial anywhere
A2. Comply with applicable data protection principles and regulations
Example: Researcher identifies examples of autonomy, justice, and beneficence in the recruitment and consent process for a clinical protocol.
B1. Critically appraise and implement the principles of trial participant protection and privacy within a clinical trial protocol
B2. Identify data protection issues and implement appropriate measures to ensure privacy
Example: Researcher explains to an independent ethics committee the plans for ensuring participants confidentiality.
C1. Supervise the implementation of activities required to protect trial participants' privacy, safety, well-being, and rights in a clinical trial
Example: Researcher responds to questions posed by a regulatory body (e.g. Swissmedic, an independent ethics committee) regarding the methods by which a clinical trial protects the rights and privacy of participants.
A1. Identify the historical events and key documents which have led to the development of the current informed consent regulations
A2. Understand the need for ethical approval to be obtained before research activities are initiated
Example: Researcher describes and understands the history and evolution of ethical principles and the key documents that ensure the protection of participants in clinical trials.
B1. Recognise the critical nature of communicating the potential risks or hazards, as well as the benefits, of a clinical trial using terminology and a manner that is understandable by potential trial participants during the informed consent process
B2. Apply knowledge of the current national and international regulations as well as available safety information when drafting an ICF for a clinical trial
Example: Researcher composes the ICF for a clinical trial and includes the potential risks and benefits in an understandable manner for trial participants.
C1. Review and control the ICF process for a clinical trial
C2. Implement processes and control measures to ensure participant protection regulations' requirements are met across clinical trials.
Example: Researcher evaluates the ICF in relationship to the trial protocol to assure that it not only meets current regulations and guidelines but also provides the information needed for a potential trial participant to make an informed decision.
A1. Identify which populations are considered vulnerable
A2. Understand that regulations are also in place to protect vulnerable populations
Example: Researcher understands these groups as being vulnerable: children, adolescents, adults lacking capacity, pregnant women, embryos and foetuses, prisoners, patients in emergency situations, mentally disabled persons, and economically or educationally disadvantaged persons. Researcher can accurately describe additional safeguards in place for each group.
B1. Accurately apply the appropriate safeguards with trial participants
B2. Anticipate situations when trial participants may be considered vulnerable
Example: Researcher applies his or her knowledge of vulnerable populations to the informed consent process, identifies other vulnerabilities, and applies safeguards for participant protection.
C1. Evaluate a trial protocol to identify whether participants are properly protected or whether additional safeguards are needed
C2. Evaluate unique situations that affect the participation of vulnerable populations and supervise others so they handle these situations appropriately
C3. Evaluate whether vulnerable populations require special considerations from the ethics committee
Example: In a community research trial of vulnerable populations, researcher develops strategies that would protect participants during recruitment and retention.
A1. Recognise cultural variations which exist when conducting multi-regional clinical trials and how they might affect the conduct of clinical trials
A2. Understand the concept of cultural competency and how it relates to the conduct of clinical trials in diverse population groups
Example: Researcher understands the importance of not conducting clinical trials that involve procedures forbidden by the religious beliefs of some groups.
B1. Compare and contrast the ethical principles guiding clinical research across different global regions: US Food and Drug Administration (FDA) versus European versus Swiss regulations
B2. Examine the pros and cons of conducting clinical trials in other countries.
B3. Understand the concept of conflict of interests and implement safeguards when conducting a clinical trial
Example 1: Within the boundaries of the trial protocol, researcher adapts clinical trial processes to the individual needs of participants, their cultural backgrounds, and the availability of medication in a given country.
Example 2: Within the boundaries of the trial protocol, researcher adapts clinical trial processes to the individual needs of participants and their cultural backgrounds.
C1. Assure that clinical trials incorporate concepts, which recognise varying cultural perspectives and ethical issues across regions
C2. Implement strategies that ensure that conflicts of interests are appropriately identified and handled
C3. Develop strategies to select clinical trial sites that appropriately balance the need to provide equal access to potential treatments
Example: Researcher ensures patients do not have to pay for treatment or procedures requested by the study (free access or reimbursement from sponsor or health insurance).
A1. Know the processes (e.g. enrolment, trial procedures, Adverse Event (AE) identification and documentation, and continuation of the trial) that appropriately balance risks and benefits.
Example: Researcher understands known and potential clinical risks associated with a trial protocol.
B1. Implement the processes (e.g. enrolment, trial procedures, AE identification and documentation, continuation of the trial) that appropriately balance risks and benefits
Example: Researcher lays out known and identifies potential clinical risks associated with a trial protocol and applies ongoing risk assessment activities during trial visits with participants.
C1. Develop the processes (e.g. enrolment, trial procedures, AE identification and documentation, continuation of the trial) that appropriately balance risk and benefit
C2. Develop a strategic recruitment and retention plan that is based on key risk and benefit components
C3. Illustrate the risk and benefit principles and methods while designing and/or providing oversight through the selection and management of clinical trial participants
Example: Researcher independently conducts a risk assessment of clinical trials.
3 — Healthcare intervention development and regulation
Encompasses the knowledge of how healthcare interventions are developed and regulated
A1. Identify the key historical events that took place which influenced the current regulatory environment that exists today.
Example: Researcher understands why the inclusion and exclusion criteria for women of childbearing potential sometimes exists in a clinical trial (e.g. birth defects with thalidomide).
B1. Demonstrate an understanding of current events that have influenced guidelines and regulatory processes concerning Swiss regulation and international guidelines.
Example: Researcher locates and describes Swiss regulations on clinical trials (Human Research Act (HRA) and its associated ordinances.
C1. Predict and/or construct adaptation plans for the new releases of existing regulations and GCP guidelines
C2. Support cross-functional team efforts and provide teaching to internal staff, investigators, and other stakeholders about pending or current guidance or regulations
Example: Researcher creates a risk-based monitoring plan for a new clinical trial to ensure compliance with Swiss regulations and GCP guidelines.
A1. Identify and understand differences between the responsibilities of investigators, sponsors, Contract Research Organisations (CROs), and competent authorities
A2. Demonstrate an understanding of the role of competent authorities (Ethics Committees (ECs), Swissmedic, Federal Office of Public Health (FOPH)) in approving protocols, assessing risks, and assessing the quality of healthcare investigation
Example: Researcher describes the role of an investigator as described in Swiss regulations and GCP guidelines.
B1. List specific roles and responsibilities for each of the parties participating in the development process (investigators, sponsors, CROs, and regulatory authorities)
B2. Recognise the scope of responsibilities of other organisations like Clinical Trial Units (CTUs), research pharmacy, Data Safety Monitoring Boards (DSMB)
B3. Understand how roles and responsibilities might differ in academia or not-for-profit research as opposed to industry
Example: Researcher explains the information required and processes used by the EC in approving protocols and assessing risk.
C1. Define the roles and responsibilities of the parties required to complete a clinical trial
C2. Evaluate the trial protocol to determine the need for collaboration between various parties/organisations
Example: Researcher assesses the need and develops a request for proposal for hiring a CTU/CRO to conduct monitoring activities for a multicentre trial.
A1. Understand concepts, major elements ,and objectives of investigational products development life cycle management process for investigational products
Example: Researcher has a basic understanding of the drug development and approval process and recognises the need to obtain approval from Swissmedic to market an investigational product in Switzerland. Researcher maintains the site’s investigational product tracking log and Case Report Forms (CRFs) and is familiar with the investigator’s brochure.
B1. Interpret and execute the concepts, major elements, and objectives of investigational product development life cycle management process for investigational products
Example: Researcher uses the kofam website to determine the category of a clinical trial.
C1. Apply the appropriate regulatory approval processes for drugs, biologics, transplants, and medical devices
Example: Researcher understands and contributes to new Investigational Medicinal Product (IMP) submission(s).
A1. Understand how to access the appropriate regulatory guidance that applies to the development and registration of healthcare interventions
A2. Demonstrate basic knowledge of human participants' protection and GCP guidelines
A3. Describe the role of Swiss regulatory authorities in the conduct of clinical trials
A4. Identify the various international regulatory agencies and their respective country-specific regulations that may affect the approval process
A5. Recognise differences in the international regulation of drugs, biologics, and medical devices.
Example: Researcher identifies the differences between the regulations and guidelines in Switzerland and Europe for the development and marketing of IMP.
B1. Compare and apply different federal (Swiss, US, EMA, or other) regulatory laws and guidance and understand how their differences could impact the conduct of trials
B2. Interpret the requirements of GCP guidelines, the approved trial protocol, and sponsor trial-related Standard Operating Procedures (SOPs)
B3. Execute the development or editing of trial-related SOPs, reports, and/or submission for the relevant regulatory approval of the trial
B4. Apply current processes and procedures for the Swiss regulatory authorities’ submission requirements for clinical trials
Example: When conducting a trial in Europe, researcher applies appropriate strategies to fulfil requirements that differ from those in Switzerland.
C1. Provide oversight and train others in relation to the relevant authority and associated regulatory frameworks, including how these harmonise with GCP guidelines, the approved trial protocol, and sponsor trial-related SOPs to ensure the safety and rights of trial participants
C2. Monitor progress and assure that the conduct of trials at site meets local, national, and global regulatory frameworks; support others to meet such requirements in the conduct of trials
C3. Develop and implement strategies for the conduct of multiregional clinical trials
C4. Analyse the resources necessary to gain approval in multiple countries
C5. Create processes to determine international site feasibility
C6. Determine and schedule the proper regulatory application requirements and timeframes for trial applications on national and international levels.
Example: Researcher knows that a regulatory application in another country may need more resources than a similar application in Switzerland. Researcher provides multiple solutions and produces training guides, documentation, and checklists to enable trial staff to ensure that the relevant regulatory framework is adhered to.
A1. Describe the specific activities and purposes of preclinical and clinical research and how they contribute to the filing of a Clinical Trial Application (CTA) and authorisation application
A2. Recognise how Phase 1–3 data contributes to the filing of a CTA and an authorisation application
Example: Researcher participates in the collection of documents necessary for the submission of an authorisation application.
B1. Actively participate in the implementation of Phase 1–3 clinical trials
B2. Differentiate between the purposes of the CTA and authorisation application and each phase of clinical development and the relationship of research questions answered at each phase
Example: Researcher uses the investigator brochure to understand and anticipate what types of potential safety risks might be associated with a clinical trial.
C1. Evaluate the feasibility of successfully implementing a preclinical or clinical protocol and determine the resources required
C2. Supervise the development, clinical planning, and implementation of a clinical trial protocol intended to contribute to a regulatory submission or clinical programme
Example: Researcher analyses data and makes a go/no-go decision after Phase 1 data are analysed.
A1. Identify the differences between AE reporting requirements for trials pre- and post-marketing approval
A2. Understand the reporting requirements for different types of AEs
Example: Researcher identifies AEs that meet the criteria to be labelled "serious".
B1. Complete and submit AE reports according to the appropriate requirements and timeline
Example: Researcher identifies, classifies, and codes an AE using source documentation and an appropriate coding dictionary.
C1. Assess the occurrence of AEs and coordinate their classification with the investigator during the conduct of a clinical trial
Example: Researcher serves as the point of contact for safety (reporting) issues, communicates the occurrence of a new AE within a clinical trial and coordinates the classification with involved investigators.
A1. Understand the application process for ethical/regulatory approvals
A2. Understand the importance of maintaining ongoing approval throughout the trial and the requirements for this, for example annual reports
Example: Researcher knows where to find the current template for annual safety reports and how to submit them to the competent authorities.
B1. Understand other relevant approvals, for example local boards and local regulatory authority permissions required
B2. Understand the processes and phases necessary for the approval of a drug or other investigational product (diagnostic, device, gene therapy, etc.) through the different stages of a trial
B3. Keep up to date with relevant international, national, and local laws, policies, and guidelines relating to clinical research (including ethical ones)
Example: Researcher identifies the relevant submission templates required (e.g. for an annual safety report), and contributes to or writes the submission.
C1. Coordinate/write submissions for ethics or regulatory approval
C2. Submit required information to trial registry
C3. Submit protocol amendments to relevant authorities
Example: Researcher coordinates, reviews, and maintains the required submissions and provides appropriate updates, for example in the case of protocol amendments or for annual reporting purposes.
4 — Clinical research operations (Good Clinical Practice)
Encompasses trial management and GCP compliance, safety management, and the handling of an investigational product (IMP, IMD and transplant)
A1. Describe basic principles of GCP
A2. Describe own role and be aware of roles of others in the site clinical trial team as set forth by the institution or organisation, regulations, and GCP guidelines
A3. Understand the concepts of delegation of responsibility and scope of practice
Example: Researcher clearly articulates own responsibilities and describes limits of one’s role in the performance of clinical trial activities.
B1. Describe how GCP principles are incorporated into clinical research
B2. Describe roles and responsibilities of EC and sponsors as set forth in Swiss regulations and GCP guidelines
B3. Perform role in accordance with Swiss regulations and GCP guidelines
Example: Researcher accurately identifies and reports situations when clinical trial team members are not able to fulfil their responsibilities and knows who to contact for support.
C1. Apply GCP guidelines to the conduct of clinical trials
C2. Review and assess all roles in the clinical trial team
C3. Supervise the clinical trial team
C4. Make sure that audits of clinical research are performed to ensure compliance with GCP guidelines
Example: Researcher assembles, supervises, and manages an appropriate clinical trial team.
A1. Follow training; describe how GCP principles are incorporated into the design of a trial protocol, the procedures followed during the conduct of a clinical trial, and the collection of trial data
Example: Researcher describes the concepts contained in the Declaration of Helsinki and how they are incorporated into GCP guidelines and implemented during the conduct of a clinical trial to ensure ethical and quality standards are maintained.
B1. Successfully participate in the implementation of a clinical research protocol and assure that, with minimal supervision, GCP principles are being followed during the conduct of the clinical trial and the collection of data
Example: Researcher leads a team that is generating and collecting data in a clinical trial in a manner that ensures the conduct, reporting, and recording of the clinical trial is in accordance with Swiss regulations and GCP guidelines.
C1. Ensure that the conduct of a clinical trial complies with GCP guidelines
C2. Appropriately resolve any compliance related issues which arise during the conduct of the clinical trial
C3. Ensure that the personnel conducting the clinical trial are appropriately trained
Example: Researcher assesses and ensures that GCP compliance is maintained throughout the conduct of a clinical trial and when appropriate mentor and train trial staff in the ethical and quality concepts required during the conduct of a clinical trial.
A1. Understand the importance of quality management systems and SOPs
Example: Researcher knows which working instructions apply to the trial.
B1. Write SOPs that are compliant with both GCP and regulations
B2. Develop and write procedures to monitor compliance to the protocol and SOPs on a daily basis and throughout the trial
B3. Develop and write procedures for quality assurance, for example how to track participants’ information and check the accuracy of collected data without breaking confidentiality rules
Example: Researcher creates an understandable SOP for a new critical process at a site.
C1. Develop a QMS with pragmatic SOPs for the whole trial and for specific sites, laboratories, or pharmacies, where appropriate
C2. Design risk management and safety plans, for example AE reporting systems and safety management plans
C3. Develop guidelines to ensure trial procedures will be consistently applied and adhered to
Example: Researcher sets up a new QMS for the site.
A1. Understand that investigational products require specific control, storage, and dispensing
A2. Follow existing SOPs for control, storage, and dispensing of investigational product
Example: Researcher locates and applies an SOP for the receipt, storage, and usage of an investigational product for a clinical trial at the clinical research site.
B1. Articulate the specific procedures and elements for the control, storage, and dispensing of an investigational product
B2. Identify any deviations in the process of investigational product handling and report/solve the issue(s)
B3. Ensure that there are robust written procedures in place relating to storage conditions and what to do when some value is outside of the specified range (e.g. temperature of storage room)
Example: When given a variety of scenarios, researcher implements the maintenance of proper environmental storage conditions, security, inventory control, and investigational product accountability (ordering, receipt, inventory, disposal, transfer) to ensure adequate and safe supplies for clinical trial participants.
C1. Develop SOPs that include specific procedures and elements for the control, storage, and dispensing of the investigational product
C2. Check the acceptability of the packaging/labelling of the investigational product (e.g. checking that it is child resistant)
C3. Ensure processes are in place for the import/export of investigational products in compliance with applicable regulations
C4. Develop Corrective and Preventive Action plans (CAPAs) when issues in the handling of trial investigational product are detected in order to avoid further deviations
Example: Researcher performs audits, generates CAPAs, and adjusts SOPs for the management of investigational products according to Swiss regulations and GCP guidelines.
A1. Recognise the differences between the different types of AEs
A2. Recognise when a Serious Adverse Event (SAE) occurs during the conduct of a clinical trial and how to report it within the appropriate time frame to the regulatory authorities
A3. Identify the differences between adverse event reporting requirements for trials pre- and post-marketing approval
Example: Researcher applies accurate classification of adverse events from sample cases (AE/ADE, SAE/SADE, SADR, SUSAR, etc.)
B1. Assess the occurrence of adverse events and coordinate with an investigator on the classification of adverse events during the conduct of a clinical trial
B2. Apply the reporting timelines and requirements for an SAE/SADE and SUSAR in Switzerland
B3. Execute the reporting of an SAE/SADE to the appropriate entity (sponsor, EC, Swissmedic, and/or FOPH) based on their respective role (e.g. investigator, CRA, sponsor)
Example: Researcher demonstrates an ability to recognise and report an SAE/SADE to the appropriate entity within the appropriate time frame during the conduct of a clinical trial.
C1. Identify and interpret safety data (e.g. safety signals or data from surveillance systems)
C2. Mentor and teach others to compare and contrast safety reporting requirements that may differ by country
Example: Researcher serves as the point of contact for both pre- and post-approval safety reporting issues and collaborates with others when responding to questions from regulatory authorities with regards to safety reporting.
A1. Understand that trial participants are entitled to protection and privacy and that national and international regulations are in place to protect trial participants during the conduct of clinical trials
A2. Immediately report protocol deviations or changes that increase risk to participants
Example: Researcher accurately describes safeguards for trial participant protection and privacy in international and Swiss regulations and guidelines.
B1. Report situations in which trial participants may require protection and privacy
B2. Coordinate unblinding and other emergency procedures when necessary
Example: Researcher describes trial visit activities, and identifies actions required for participant protection and privacy appropriate for the regulatory body and regulation for different countries (e.g. HRA, Swissmedic, swissethics).
C1. Set up an appropriate system for trial participant protection
Example: Researcher implements a DSMB if necessary.
A1. Recognise and understand the rationale and purpose for systematic, prioritised, risk-based clinical monitoring and the national regulations and GCP guidelines to improve the quality of conduct of the trial and its integrity, consistency, timeliness, and accuracy
A2. Adhere to the monitoring plan and applicable SOPs
A3. Inform others when confronted with issues not detailed in the monitoring plan
Example: Researcher participates in local Quality Assurance (QA) audits of clinical trials in preparation of a monitoring visit.
B1. Address complex monitoring issues with minimal supervision or guidance
B2. Provide guidance to others to resolve monitoring issues
Example: Researcher applies prospective risk-based approaches to ensure quality data and rapid as well as accurate responsiveness to clinical monitoring queries.
C1. Employ and implement a systematic, prioritised, risk-based clinical monitoring plan to complete monitoring tasks/activities
C2. Lead the monitoring effort by mentoring others in the planning and conduct of monitoring site visits
C3. Oversee the creation and planning of systematic, prioritised, risk-based trial-specific monitoring plans that assure sufficient resources are allocated to ensure the timely review of data while maintaining established standards for trial participant safety and data integrity
Example: Researcher creates systematic, prioritised, risk-based clinical trial monitoring plans, provides leadership, mentoring, and guidance to ensure all monitoring activities and workflows are compliant and are "audit-ready".
A1. Understand the difference between an audit and an inspection
A2. Name the entities which have the authority to conduct audits and inspections
A3. Locate and explain the Swiss regulations governing audits and inspections
Example: Researcher assists with the preparation for clinical trial audits and understands the roles of the trial staff during an audit or inspection.
B1. Distinguish between the scope of audits/inspections conducted by sponsors, an EC, and a regulatory authority
B2. Identify research components inspected during a clinical trial audit and inspection
B3. Distinguish between routing and for-cause audits and inspections
Example: Given a clinical trial protocol, researcher classifies and categorises the specific information and sources of data required by auditors and inspectors.
C1. Supervise preparations for an audit/inspection conducted by a sponsor or regulatory authority
C2. Develop policies and SOPs in response to audit/inspection findings
Example: Given an audit report, researcher creates a comprehensive CAPA plan to respond to audits/inspections and develops appropriate SOPs.
A1. Understand that safety is a central issue in clinical trials and that a lack of safety oversight can jeopardise participants and the trial in numerous ways
A2. Recognise the tools and processes implemented in a clinical trial to protect participants
A3. Remember to report suspicious activities or events which might compromise safety
Example: Researcher identifies safety issues, risk mitigation, and action plans for diabetic patients who are required to be fasting for a lengthy trial visit.
B1. Execute safety reporting within the required timelines through appropriate channels
B2. Classify safety issues and report them to the competent authorities
B3. Relate safety issues according to monitoring and pharmacovigilance plans
Example: Researcher generates SOPs for the handling of safety hazards at the clinical trial site as well as for detecting and reporting AEs.
C1. Anticipate possible safety issues during the clinical trial implementation
C2. Institute measures to minimise risks
C3. Review and improve monitoring and pharmacovigilance plans
C4. Recommend and conduct safety training for trial staff
C5. Implement international guidelines and requirements across relevant agencies (e.g. ECs, Swissmedic, FDA, EMA, ICH)
Example: Researcher develops a CAPA plan and trial staff training to monitor findings of under-reported AEs.
A1. Understand when insurance is required for clinical research
Example: Researcher understands the difference of insurance requirements of the various trial categories.
B1. Understand the roles and responsibilities involved in planning appropriate liability/insurance cover
B2. Can report accordingly if a claim is required
Example: Researcher detects possible claims during the trial and reports them to sponsor.
C1. Secure appropriate insurance/liability for a trial.
5 — Trial and site management
Encompasses the content required at the site level to run a clinical trial (e.g. infrastructural, financial, and personnel aspects); includes site and trial operations (not necessarily encompassing regulatory/ GCP guidelines)
A1. Demonstrate a basic understanding of baseline determinants of new trial selection process at a research site
A2. Understand the purpose of site selection visits
A3. Participate in virtual or face-to-face pre-study visits
Example: Given a new potential protocol, researcher understands trial-related needs in order to be able to do the trial at the site, including the availability of a specific trial population.
B1. Provide input and guidance in the trial selection process, including the ability to assess the financial and logistical feasibility of conducting a trial at the research site
B2. Assist in organising and conducting site selection visits
B3. Assist in estimating budgets for a potential trial
Example: Researcher completes a feasibility assessment checklist for a new potential trial, including preliminary budget estimates.
C1. Guide trial selection on a programme or institutional level
C2. Defend trial selection decision-making, including the determination of scientific validity and value, favourable risk/benefit ratio, and operational (logistical and financial) feasibility
C3. Lead the negotiation and creation of tools, guidance documents, and policies to guide the decision-making process in trial selection and participation
Example: Researcher creates a trial feasibility tool used throughout departments and evaluates assessments to make recommendations.
A1. Identify the component parts of a clinical trial budget
A2. Have an awareness of the trial budget, operate within financial constraints, and assist others in doing so
Example: Researcher organises trial visits as well as requisite labs using the correct requisition and account numbers for the trial and is able to track and reconcile those documents.
B1. Evaluate and recommend changes to proposed financial budgets, timelines, and the amount/type of infrastructure and personnel necessary to conduct a clinical trial (project planning skills)
B2. Assist in budget negotiations and funding agreements
B3. Manage expenses, for example prepare invoices, travel expenses, and participant reimbursements
B4. Alert relevant personnel to potential escalating consumable and other costs associated with a clinical trial
Example: Researcher analyses a trial budget to ensure all requirements of the protocol are included.
C1. Develop the budget, timeline and/or infrastructure and personnel resources needed to conduct a clinical trial (project planning responsibility)
C2. Monitor the progress of a clinical trial towards milestones and identify trends or risks during trial execution. Implement mitigation plans
C3. Manage personnel that is assigned to the clinical trial
C4. Allocate and manage trial budget and forecasting
C5. Maintain accurate accounts, synthesise financial information from multiple sources to create reports and ensure up-to-date financial information is available and circulated
Example: Researcher generates amendments to a trial budget and milestone timelines to reflect new requirements for an amended protocol and to address unforeseen cost issues for the conduct of a clinical trial.
A1. Understand major funding bodies and that application requirements vary from one to another
B1. Understand the funding application process
C1. Plan costings and resources for funding
C2. Independently write and submit funding applications or contribute to funding
C3. Seek to address funders’ interests by developing original projects
C4. Develop cost-effective, risk-based strategies to run clinical research trials
A1. Identify the mechanisms used in a clinical trial that have been put in place to mitigate risk
A2. Understand how risk assessments are conducted for clinical trial operations and patient safety
Example: Researcher articulates potential reasons why a key performance indicator might be compromised (e.g. trial participants are not completing trial visits within the time window defined in the protocol) and operations that might ensure the lowest risk of occurrence.
B1. Identify and understand the importance of the QMS plan and teach others about the overall scope of the QMS
B2. Implement risk mitigation steps as defined in the plan and develop a strategy to educate others on its content and application
Example: Researcher analyses reports and implement defined risk mitigation steps when key performance indicators have been triggered.
C1. Develop both generalised and trial-specific QMS training programmes and deliver these programmes to others
C2. Define key performance indicators for clinical trials and incorporate them into the trial-specific QMS plan
C3. Interpret internal QA data on key performance indicators and strategies to mitigate risk through a CAPA plan
Example: Researcher analyses and reports quality audit findings, presents them as discussion topics for mitigation strategies during staff meetings, and/or incorporates them as part of QMS training programmes to ensure staff understand how a QMS applies to a clinical trial.
A1. Articulate expected recruitment and retention rates
A2. Identify and use tools, strategies, and procedures for implementing and tracking of participant recruitment and retention
A3. Describe local and international regulatory requirements that influence the use of different recruitment tools
Example: Researcher identifies documents and systems used to track the recruitment and retention of participants.
B1. Interpret participant recruitment and retention tracking data to determine if changes are needed
B2. Develop basic methods for capturing and reporting on recruitment and retention
B3. Apply local and international regulatory requirements to the use of different recruitment tools
Example: Researcher creates a recruitment plan that addresses the needs of the trial population with regards to age, gender, and distance and develops participant flyers for the EC submission that will aid in recruitment.
C1. Innovate solutions to recruitment and retention challenges incorporating key ethical considerations
C2. Propose different recruitment tools based on national regulatory requirements
Example: Given a scenario of a trial with faltering recruitment or retention, researcher creates innovative solutions that are evidence-based and clearly address the specific needs of hard-to-reach/engage populations. The solution includes plans to frequently review the success of the strategies.
A1. Organise and maintain trial regulatory documents and grants/contracts documents for regulatory and institutional compliance audits
A2. Understand the purpose of trial legal materials including, for example, the contract, budgets, indemnification, confidentiality disclosure agreements, material transfer agreement, conflict of interest reporting, and EC approvals in a compliant trial site
B1. Organise and appropriately process contracts, materials transfer agreements, budgets, indemnification agreements, confidentiality agreements, and conflict of interest reporting.
B2. Develop and/or follow SOPs that mitigate legal risks in conducting clinical trials.
Example: Researcher reviews an ICF to ensure that the indemnification language in the clinical trial agreement is in line with indemnification statements in the protocol, the ICF, and institutional policy.
C1. Monitor systems and collaborate with institutional bodies to ensure compliance with legal and ethical requirements in the conduct of clinical research at the organisation
C2. Develop and evaluate legal risk mitigation strategies, associated action plans, and issue resolution
C3. Negotiate legal contracts (including budgets), confidentiality agreements, and conflict of interest documents with the help of a lawyer/legal adviser
Example: Researcher serves on a conflict of interest board for an institution.
A1. Understand the different procedures with all stakeholders (principal investigators, sponsors, CROs, and competent authorities) in the conduct of a clinical trial
Example: Researcher catalogues and files all regulatory documents, including ICFs and the recruitment material necessary for an EC submission.
B1. Understand and articulate applicable regulations and accurately follow established processes in place to ensure compliance
B2. Describe the various trial staff roles (sponsor, PI) and their responsibilities in the compliant conduct of a clinical trial
B3. Describe the impact of compliance on the safe and ethical conduct of clinical trials
Example: Researcher processes an EC submission for a new clinical trial.
C1. Apply an advanced understanding of regulations and demonstrate the ability to accurately interpret regulatory guidance and mentor others in the translation of regulations into everyday practice
C2. Create strategies, policies, and procedures to ensure regulatory compliance at a departmental or institutional level
C3. Organise and manage regular, trial-related meetings with trial staff
C4. Work together with regulatory authorities, for example during inspections or when submitting reports
Example 1: Researcher reviews and assesses clinical trial regulatory documents.
Example 2: Researcher generates a delegation of authority log that clearly delineates staff roles in conducting a trial according to levels of responsibility and scope of practice.
A1. Understand project scope, milestones, and timelines and track them appropriately.
A2. Track the progress of trial, using tracking tools or software if appropriate, and measure progress against planned objectives and targets
Example: Researcher assumes the responsibility for single tasks, for example drug accountability or temperature logs.
B1. Use progress tracking to anticipate potential issues so initiative can be taken for resolution
B2. Ensure the timeliness of reporting relevant milestones.
Example: Researcher assumes the responsibility for the delegation list and oversight of human resources at the unit level.
C1. Review protocols and conduct feasibility planning and risk assessments
C2. Recruit trial teams, quality control teams, and oversight committees such as steering committee as needed
C3. Oversee trial and site management, including managing multiple sites/laboratories/CROs, and ensure consistency, including in the planning of work schedules
C4. Track trial progress (recruitment, milestones, deadlines, objectives, goals, and targets) including the appropriate reporting and other specified processes within the trial (e.g. trial supplies, monitoring, and follow-up)
C5. Maintain a trial document archive inventory. Plan and coordinate data and source document archive for specified period
C6. Plan and conduct trial termination as appropriate for participants, site(s), laboratories, trial type, etc.
C7. Give notification of trial closure/termination: inform and submit relevant reports to competent authorities and other people involved (investigators, institution, trial participants, etc.)
C8. Ensure and oversee close-out activities in case of premature termination of the trial, site, or participant's involvement in the trial
C9. Perform audits as required
Example: Researcher plans and coordinates trial initiation process (initial requirements for infrastructure and facilities, supplies, staff, training, etc.), in particular laboratory and pharmacy start-up activities.
A1. Report appropriately when required within the team (e.g. on the workload, logistics, status of the project)
A2. Escalate issues or concerns appropriately
A3. Understand reporting requirements for diverse parties (e.g. ECs, sponsors, funders, and competent authorities as opposed to the trial management team, steering committees, and safety monitoring boards)
Example 1: Researcher is aware of recruitment (number of patients/participants, number of visits, etc.)
Example 2: Researcher collects and documents AEs and prepares reports (prepare summaries).
B1. Write suitable reports according to the target audience and present information clearly
B2. Prepare for, participate in, and present clearly at meetings as required
Example 1: Researcher summarises recruitment status (participant logs).
Example 2: Researcher notifies AEs to ECs and competent authorities and sends reports according to timelines.
C1. Assume responsibility for the quality, coordination, medical and otherwise scientific accuracy, and timeliness of relevant reports
C2. Organise and conduct meetings or teleconferences (ensure that the right people are invited, make practical arrangements, prepare agendas, write minutes, delegate tasks as appropriate, etc). Implement continuous progress surveillance for decisions made in meetings.
Example: Researcher oversees the entire project, including resources and timelines.
A1. Understand why and in which circumstances contracts are needed within a clinical trial
Example: Researcher knows where to find existing third-party contracts (e.g. with a laboratory).
B1. Manage contracts – including (but not limited to) investigator contracts, the sponsor/site agreement, site agreements, agreements with a CRO or subcontractors, and data access and transfer agreements – in compliance with confidentiality requirements and arrange for compensation in the event of harm
Example 1: Researcher initiates all contracts needed.
Example 2: Researcher notifies the appropriate bodies of the occurrence of insured events.
C1. Appropriately write and review contracts to ensure they are comprehensive
C2. Sign contracts if authorised by the institution and/or organise the signing of contracts
C3. Ensure that specified subcontracted responsibilities (e.g. to a CRO) are documented according to the signed contract
Example: Researcher oversees detailed content of contracts and policies.
6 — Data management
Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, correction, and database lock
A1. Understand the basic purpose of data that are collected in a clinical trial
Example: When reviewing a protocol and CRF, researcher recognises the data points that are associated with the analysis of safety and efficacy endpoints.
B1. Appropriately summarise and interpret data of a clinical trial
Example: Researcher generates descriptive statistics to illustrate enrolment and safety data in a trial for a staff meeting presentation.
C1. Critically review a statistical analysis and data management plan for a clinical trial
Example: Researcher develops and annotates a CRF for a clinical trial that will ensure accurate data analysis.
A1. Describe the basic concepts of clinical data management
A2. Identify the various sources of data that contribute to a clinical trial and distinguish the different standards to be used in their handling
Example: Researcher understands the purpose and scope as well as the process workflow of data collection.
B1. Apply all aspects of the Clinical Data Management Plan (CDMP) to an active clinical trial with regards to the flow of data from the site to the clinical database as well as the flow of data from other sources, for example laboratory electronic uploads and Electronic Medical Record (EMR) transfers
B2. Manage queries and recommend whether the flow and quality of the clinical data meets the standards set in the CDMP
Example: Researcher performs an analysis of the data flow from various sources (e.g. e-sources and third-party sources) to ensure clean data transfers per predefined specifications.
C1. Analyse and modify SOPs, when necessary to accommodate the inclusion and implementation of new technology in the data management process or new initiatives (e.g. data transparency and clintrials.gov requirements or initiatives on data sharing)
C2. Educate and mentor others concerning their role and responsibility in the conduct and management of clinical data across each aspect of the clinical trial
Example: Researcher participates at in an investigator meeting to review the clinical data management process and the responsibilities each PI and site has in this process.
A1. Identify and apply standard and best practices for data management in a clinical trial
A2. Identify documents and resources related standards and best practices associated with the collection, data capture, data management, data analysis, and data reporting in a clinical trial
Example: When given standardised scenarios, researcher identifies a standard or best practice (for data collection, capture, management, analysis, and reporting).
B1. Implement industry, Swiss, and GCP accepted standards and best practices for data management in a clinical trial
B2. Perform data management activities across clinical trials from the creation of protocol-specific source documents to the collection and entry of data and the performance of quality audits
B3. Collaborate with IT and implementation team(s) to address changes to clinical trial database systems
Example: Researcher collects and enters data into new electronic data collection forms (eCRFs) with timeliness, accuracy, and low query rates.
C1. Develop a data management plan for a clinical trial that includes standardised plans for data collection, data capture, data management, data analysis, and data reporting and uses standards or best practices
C2. Design a database appropriately for data specifications, user requirements, edit rules, query logic, and data validations; build and test a database according to the develop test scripts and ensure that the database supports an audit trail
C3. Operate data management system
C4. Ensure safe and secure storage of data
C5. Audit databases to validate programming and quality checks
Example: Researcher develops an annotated CRF for a specific trial according to the trial specific data management.
A1. Identify and understand processes that assure data quality
A2. Recognise whether individual pieces of data collected in a clinical trial are attributable, accurate, complete, and verifiable from the source data
A3. Be familiar with electronic data collection processes or smartphone data collection
Example: Researcher enters and corrects data from a source document into an eCRF while keeping a log of discrepancies and resolving data queries.
B1. Independently ensure compliance with SOPs related to data quality
B2. Provide input and share ideas, proactively and reactively, related to data quality and its related processes.
B3. Manage data collection and insertion into CRF or other storage format, ensuring the data is accurate, complete, within timelines, and with a low query rate (attributable, legible, contemporaneous, original, accurate, and complete, (ALCOA-C))
B4. Responsible for receiving and checking the data prior to data entry and maintaining a log of incomplete or missing data
B5. Ensure all AEs are entered into the database
Example: Researcher suggests a change in an eCRF design to a sponsor to help avoid recurrent queries.
C1. Create/define SOPs related to data quality or trial-specific procedures for the conduct of a clinical trial
C2. Advise the data management team on processes related to data quality that impact the trial staff and ensure a smooth and constructive collaboration and communication between them
C3. Train trial staff on procedures related to data quality and provide oversight and support in cases of doubt or risk for non-compliance
Example: Researcher generates an eCRF that complies with data quality standards defined by the institution or company.
A1. Understand that clinical study data can be analysed with different methods
A2. Critically appraise the statistical analysis description in a clinical trial protocol
Example: Researcher discusses the statistical analysis with the trial statistician.
B1. Identify and articulate whether or not any conclusions drawn from analyses of data are valid and based on the material provided
B2. Interpret efficacy and safety data from clinical trials
Example: Researcher monitors missing data and takes appropriate actions to ensure the validity of the analysis.
C1. Extract data from a database and conduct data analysis using statistical software packages (e.g. compute rate, ratio, and percent, and interpret bar graphs)
C2. Perform statistical monitoring of data and an interim analysis
C3. Apply modelling and simulation knowledge using quantitative data and the appropriate technology
Example: Researcher applies appropriate statistical tests to outcome data using statistical software.
7 — Leadership and professionalism
Encompasses the principles and practices of leadership and professionalism in clinical research
A1. Display professionalism in the workplace: in attire, attitude, work-ethic, and quality
A2. Know the leadership structure of the organisation
A3. Locate, comprehend, and adhere to the SOPs in the research department
A4. Demonstrate initiative and team cooperation in performing trial duties
Example: Researcher arrives at work on time, articulates information in a succinct and appropriate manner both verbally and in writing, and seeks guidance or directions when questions arise.
B1. Assist others with various aspects of trial management using effective communication methods and documentation
B2. Train and mentor less experienced staff
B3. Demonstrate effective time management and organisational skill when managing multiple trial related projects
Example: Researcher plans and conducts a protocol implementation meeting.
C1. Provide leadership and strategic vision to one's organisation and encourage the evaluation of current service and change where necessary
C2. Train and mentor new staff members and team members
C3. Manage multiple complex trial operations
C4. Set strategic planning goals and objectives for trial performance
C5. Encourage a culture of continual improvements in the department, encourage the streamlining of processes, and guide colleagues through the process of change
C6. Contribute to the development and updating of research policies and procedures, in one's department or nationally
C7. Share best practices in clinical research to develop capacity, whether within the organisation or further afield
C8. Establish and maintain relationships with a strategic network of scientists and collaborators to facilitate the work of the department and build capacity
Example: Researcher manages trial teams, develops budgets, and assists with contracts for clinical trials.
A1. Explain the nature and historical instances of ethical and professional conflicts which occur in the conduct of clinical research
A2. Understand the procedures which are implemented to prevent ethical conflicts and support risk management strategies
Example: Researcher identifies an ethical conflict within a clinical trial and communicates accordingly.
B1. Recognise, implement, and manage the procedures in a clinical trial which minimise the risks of ethical and professional conflicts
B2. Implement risk management strategies within the responsibilities of one's role
Example: Researcher organises and implements the procedures (such as participant recruitment strategies and informed consent) which are included in a clinical research protocol that mitigate ethical and professional risks to clinical trial integrity and contributes to risk management planning for a trial team.
C1. Assess the risk of ethical and professional conflicts inherent in a clinical trial
C2. Develop strategies and policies to implement and manage the risk of ethical and professional conflicts across a trial team as well as functional domains
C3. Take personal responsibility for all decisions and actions
Example: Researcher appraises the potential risks (both ethical and professional) inherent in the conduct of a clinical trial and develops a framework for risk management for a department or a trial team.
A1. Recognise the key documents which make up the foundation of the regulations that ensure clinical trials are conducted ethically and in a professional manner
A2. Identify and understand the meaning of ethical and professional behaviours found in both federal regulations and international guidelines addressing ethical conduct in clinical trials
Example: Researcher identifies the key regulations and guidelines in Switzerland and ICH-GCP documents that ensure ethical conduct in clinical trials.
B1. Apply professional and ethical regulations and international guidelines in each facet of clinical research
B2. Demonstrate through one's actions and documentation of tasks during the conduct of clinical trials an understanding of how appropriate procedures and processes assure professional and ethical conduct throughout the clinical trial
Example: During day-to-day activities and tasks, researcher demonstrates professional behaviour and ethical integrity through the applications of all established processes, procedures, regulations, and guidelines.
C1. Evaluate, and modify when required, internal policies and procedures to ensure that the organisation’s code of ethical conduct is compliant with national and international regulations and guidelines
C2. Mentor, educate, and provide guidance to all trial team and staff members on internal processes and procedures which ensure that all aspects of clinical trials are conducted within the bounds of ethical conduct
Example: Researcher ensures that all national and international regulations and guidelines are reflected in SOPs and processes by adapting any established procedures, processes, or workflows to reflect any new or updated regulations and/or guidelines (e.g. training documentation).
A1. Describe why it is important to incorporate strategies that account for regional and cultural diversity in the conduct of a clinical trial
A2. Classify examples of potential impact that are related to diversity or cultural competency
Example: Researcher suggests strategies to address diversity and cultural competence for a diverse set of potential participants in a clinical trial, including age, ethnicity, race, gender, and religion.
B1. Apply regional/country and cultural considerations during trial design and conduct
B2. Incorporate the appropriate regulatory requirements during the implementation of multi-country trials
Example: Researcher recognises cultural and diversity issues when developing a research idea into a global clinical trial.
C1. Develop specific strategies or methods for considering culture and region/country when designing and conducting trials in multiple regions/countries
C2. Validate that regulatory requirements are incorporated into the trial design for multi-country trials
Example: Researcher proposes specific strategies that can be employed in each region/country to ensure cultural and regional appropriateness when initiating a new clinical trial.
A1. Understand the importance of teamwork in trial conduct and how to work in a multidisciplinary and interprofessional team effectively (e.g. with people with different backgrounds and different levels of training)
A2. Demonstrate good time management: be able to multitask and prioritise competing deadlines, needs, and demands from colleagues
A3. Deliver work at the agreed time and work effectively under pressure and in a stressful environment
A4. Listen effectively and encourage communication in an open way
A5. Recognise one's limitations or learning needs and take responsibility for maintaining up-to-date knowledge
A6. Be able to work autonomously, with minimal supervision, or collaboratively in a team (good self-management)
A7. Be able and willing to take and follow instructions
A8. Respond positively to requests and change; be willing to take on additional roles if necessary (remain flexible)
Example: Researcher recognises conflicts and communicates them appropriately to superiors.
B1. Demonstrate conflict management/mediation skills: be able to discuss issues with people who disagree on a topic (conflict management/mediation skills)
B2. Demonstrate advocacy skills: enable those who find it difficult to express themselves to articulate their views (advocacy skills)
B3. Listen effectively and encourage open communication, diplomacy, and sensitivity; promote respect and courteous treatment of others
B4. Show tact and careful and good judgement when dealing with sensitive or personal information/issues
Example: Researcher solves conflicts, for example between team members.
C1. Demonstrate negotiation skills
C2. Demonstrate effective networking skills; build alliances and strategic partnerships
Example: Researcher sets up new cooperation for a clinical trial and adjusts if necessary.
8 — Communication and teamwork
Encompasses all elements of communication within the site and between the site and the sponsor, CRO, and regulators as well as understanding of teamwork skills necessary for conducting a clinical trial
A1. Understand and describe the relationships and appropriate communication channels between regulators, sponsors, CROs, and trial sites
Example: Researcher demonstrates appropriate written and oral communication between stakeholders in the clinical trial operation.
B1. Apply appropriate, professional communication practices in written and verbal interactions with other parties in order to maintain legal and productive relationships during the conduct of a clinical trial
Example: Researcher develops proactive written and oral communication that addresses team-related challenges that could affect trial execution so that solutions can be developed to address the challenges.
C1. Establish and maintain productive, long-term relationships with all participating parties across the research enterprise to sustain efficient, effective, and sustainable clinical trials in the present and in the future
Example: Researcher anticipates the needs of all parties participating in the clinical trial and serves as a communication mediator when difficult situations arise that have had previous unsatisfactory results.
A1. Identify the component parts of a scientific publication and the general purpose of each part
A2. Comprehend that a traditional scientific publication describes the outcomes of a research trial in a structured and ordered format to contribute to generalisable knowledge and evidence-based practice
A3. Be aware of the concept of plagiarism and of requirements for citing others’ work
A4. Assist in the preparation of and/or deliver of (oral or poster) presentations at conferences/meetings
Example: Researcher reviews and discusses a published trial associated with an ongoing clinical trial protocol.
B1. Describe the methods for a clinical trial that have been published and appreciate the basis for the conclusions made from the results obtained
B2. Search literature using key terms to find articles on specific participant populations
B3. Explain the difference between a primary source and a secondary source when citing professional literature
B4. Coordinate or contribute to the process of writing a publication or final report
B5. Write and submit abstracts to conferences or journals
Example: Researcher composes an abstract for a publication or professional presentation and accurately cites relevant literature using primary source data (e.g. can trace a secondary source back to the originating primary source).
C1. Navigate, appraise, and assess the content of all component parts within a traditional scientific publication and communicate a detailed understanding to staff
C2. Describe the relationship of the findings from a clinical trial and the current practice context to the relevant human population
C3. Write and edit manuscripts as well as apply the different requirements and formats of journals
C4. Develop communication and awareness programmes for results
Example: Given the results of a clinical trial, researcher generates and edits a manuscript and/or responds to editorial comments and suggestions in order to develop a final and accepted professional publication.
A1. Understand the structure and contents of a scientific publication
A2. Identify and utilise reliable sources of information which communicate clinical trial findings to the scientific and non-scientific communities
A3. Communicate clearly in writing and orally
A4. Understand the communication and liaising required as part of a trial at different levels
Example: Researcher explains the scientific findings of a clinical trial in terms that can be understood by the non-scientific community.
B1. Relate the content and value of clinical research trials to colleagues and to the non-scientific community through professional presentations and other verbal and written means
B2. Deliver effective an presentation
B3. Translate documents or organise translations
Example: Researcher writes lay summaries of clinical trials for a journal club or to potential patient populations.
C1. Design reports for scientific and non-scientific communities which interpret and explain clinical trial data and appraise the significance of clinical trial reports
C2. Facilitate the awareness and further understanding of clinical research protocols and their results to colleagues, advocacy groups, and the non-scientific community
C3. Adapt communication as required depending on the audience to coherently deliver message
C4. Liaise appropriately and regularly with the relevant groups and keep groups informed of progress, developments, and issues
C5. Be able to act as the primary contact for authorities, media, CROs, etc.
C6. Process communications received and ensure a timely and complete response
Example: Researcher communicates outcomes of a clinical research trial to sponsors, colleagues, and the non-scientific community.
A1. Describe and understand the importance of an interdisciplinary team and the values each member can bring to clinical trials
A2. Identify and recognise each member of the team and his or her respective roles and responsibilities and understand that communication within a clinical trial team is vital to the success of the trial.
Example: Researcher understands the professional roles and clinical practice domains of all members of the clinical trial team.
B1. Identify and facilitate the activities of the key contacts essential to ensuring effective team operations during a clinical trial
B2. Demonstrate an understanding of a cross-functional team in developing a communication plan
Example: Researcher demonstrates the ability to perform the day-to-day operational activities critical to running an effective team (e.g. setting up meetings, developing a communication plan, identifying of key contacts both within the team and outside of the team).
C1. Mentor others on how to work best on a multifunctional clinical trial team
C2. Establish the core infrastructure of the clinical trial team and ensure effective and efficient communication and teamwork
C3. Incorporate multidisciplinary skills into trial teams
Example: Researcher creates trial teams and establishes an operational workflow to implement trial team communication and cross-training, ensures training documentation is maintained, and provides guidance when needed in order for teams to optimise their effectiveness.
A1. Understand the communication and liaising required as part of a trial – for example communication with the sponsor, sites, PIs, stakeholders, and monitors – to ensure the smooth and successful execution of trial activities
Example: Researcher defines the role of each trial team member in the implementation of a protocol addendum.
B1. Liaise appropriately and regularly with the groups according to their role and keep groups informed of progress, developments, and issues
B2. Ensure that relevant documents are communicated with the team
Example: Researcher sends the latest version of the investigator’s brochure with the explanatory accompanying letter to groups and to the respective teams.
C1. Be able to act as the primary contact for authorities, media, CROs, etc.
C2. Process communications received and ensure a timely and complete response
C3. Interact with staff in other functional areas to ensure the highest level of collaboration across groups
Example: Researcher creates a workflow and defines the relevant data to be collected to reply to a request from authorities for additional information on safety.