Core competencies

Fundamental level
A1. Have sufficient medical and clinical knowledge in the medical area in which one will support clinical trials

Skilled level
B1. Be an expert for all health-related aspects in the medical area in which one will conduct clinical trials

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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).

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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. 

Skilled level

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.

Fundamental level

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).

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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".

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

A1. Understand the importance of quality management systems and SOPs

Example: Researcher knows which working instructions apply to the trial.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.)

Skilled level

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.

Fundamental level

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.

Skilled level

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).

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

A1. Understand when insurance is required for clinical research

Example: Researcher understands the difference of insurance requirements of the various trial categories.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

A1. Understand major funding bodies and that application requirements vary from one to another

Skilled level

B1. Understand the funding application process

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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).

Skilled level

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.

Fundamental level

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).

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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).

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.   

Skilled level

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.

Fundamental level

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.

Skilled level

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.  

Fundamental level

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.

Skilled level

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.  

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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.

Fundamental level

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.

Skilled level

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).    

Fundamental level

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.

Skilled level

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. 

Fundamental level

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.

Skilled level

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).

Fundamental level

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.

Skilled level

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.