WHAT ARE DOMAINS AND LEVELED CORE COMPETENCIES?
The JTF Core Competency Framework is made up of 8 Competency Domains which are broad categories of knowledge, skills, and attitudes necessary for conducting clinical research.
Click here for information about how to reference the JTF Framework.
Within each Domain are specific competency statements which are expressed at a Basic, Skilled and Advanced level.
- Fundamental (“Can perform the task/and or exhibit the knowledge at an essential or fundamental level; may require some coaching or supervision”)
- Skilled (“Can perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high-quality work; able to independently navigate resources and uses tools well”), and
- Advanced (“Demonstrates advanced skills and knowledge and the ability to teach, coach, or supervise others. Consistently applies critical thinking and problem solving”
For each of the 47 Leveled Competency statements an example is provided of how the competency may be implemented in a clinical research environment. Translations of the JTF Framework can be accessed and downloaded in various languages. Additional translations are in progress.
Learn more about the competency domains and statements below. Please click on “+” for each category below to view.
Domain 1: Scientific Concepts and Research Design
Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize the need to apply scientific principles to discovery and development of biomedical investigational products and health-related behavioral interventions | B1. Apply scientific principles when implementing a clinical or behavioral study | C1. Plan biomedical research according to scientific principles |
| A2. Explain the basic scientific principles that should be applied during development of biomedical investigational products and health-related behavioral interventions | B2. Implement data collection according to scientific principles and based on protocol design | C2. Develop a data management plan according to scientific principles. |
| Example: When reviewing a clinical research protocol, researcher describes the objective and scientific techniques used to design and implement biomedical research. | Example: When given a clinical research protocol, researcher differentiates what principles could affect how the data should be collected and implement best practices accordingly. | Example: Given a clinical research protocol and data collected, the researcher evaluates the findings to assess results via a scientific framework. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Articulate the purpose of the study | B1. Identify the research hypothesis in a study protocol | C1. Develop a protocol that appropriately includes distinct research activities and standard of care |
| A2. Describe the importance of the study | B2. Identify endpoints (primary and secondary) that will be used in data analyses to measure outcomes | C2. Align parameters for collecting data on endpoints with objectives |
| Example: Identifies the following elements in selected study protocols: Study title, Key purpose of the study, Why this study is important to be done, Who the specific population for the study is | Example: When given a study protocol, describes and classifies the objectives and associated safety and efficacy endpoints that will be used to test the hypothesis and identify assessments (clinical, social/ behavioral, or economic) that will be used to measure endpoints. | Example: Develops presentations to educate others on the scientific feasibility and conduct of the study to ensure quality collection of endpoints for hypothesis testing. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the key elements of a clinical study protocol | B1. Review a clinical study protocol to ensure all needed elements are included | C1. Evaluate the clinical study design and make adjustments to the processes as needed |
| A2. Describe the general process of clinical study protocol development | C2. Develop protocols as applicable to the therapeutic area | |
| A3. Recognize the basic differences between the various types of clinical studies | C3. Evaluate strengths and weakness of study designs and explain these to others | |
| C4. Develop specific strategies for considering culture and region/country when designing and conducting studies in multiple regions | ||
| Example: When given a clinical study protocol, identifies the inclusion and exclusion criteria for a set of mock participants. | Example: When given a clinical study protocol, identifies missing, incomplete or inappropriate features. | Example: When given a clinical study protocol that has misalignment between the measures and objectives, researcher appropriately modifies the protocol. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize the utility of new technologies and techniques which may facilitate the conduct of a clinical study | B1. Identify and apply new technologies and techniques which enhance the quality, conduct and safety of the clinical study | C1. Perform data-driven decision-making process, and integrate new technologies and techniques into the development and conduct of clinical studies |
| B2. Implement training programs relating to new technologies and techniques that enhance the conduct, safety, and validity of the clinical study | C2. Design and optimize training programs for clinical study staff which incorporate new technologies and techniques | |
| Example: Demonstrates ability to work on appropriate electronic clinical platforms which utilize mobile devices or the internet to manage study conduct. | Example: Leads a team that is able to utilize tools and appropriate data capture methods such as electronic clinical outcome assessments (eCOA) to increase the quality of data collected. | Example: Analyzes reported data and implements modifications by utilizing data from different sources such as a Clinical Trial Management System (CTMS) relating to measurable Key Performance Indicators (KPIs). |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the study results | B1. Compare and assess the level of quality of results associated with study reports and publications | C1. Assess the potential for application of findings |
| A2. Describe the relevance of the results to the research question | B2. Understand descriptive and exploratory data analysis | C2. Identify trends and anomalies within the clinical study data |
| Example: When given study reports, paraphrases and summarizes the study results. | Example: When given two publications researching the same topic, researcher compares and contrasts what could have affected how the data from the two could be interpreted. | Example: Conducts pharmacovigilance assessments of collected data and generates queries to close data gaps. |
Domain 2: Ethical and Participant Safety Considerations
Encompasses care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial
| Fundamental Level | Skilled Level | Advanced |
|---|---|---|
| A1. Explain that a clinical study is unconfirmed research and not accepted standard of care | B1. Demonstrate the importance of conducting clinical trial activities as per the protocol | C1. Develop a protocol that appropriately includes distinct research activities and standard of care |
| Example: Explains to a study participant that procedures that are part of the protocol are not necessarily standard of care. | Example: Explains to clinical staff the timing of a research blood draw versus standard blood draw timing for the shift. | Example: Appropriately distinguishes between activities that should be billed to insurance versus incorporated into sponsored cost. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize that clinical equipoise and therapeutic misconception are fundamental ethical principles and concerns that underlie clinical research | B1. Explain the rationale of clinical equipoise and therapeutic misconception, and can demonstrate comprehensive knowledge and understanding of how they may impact patient understanding | C1. Act as an expert resource to potential study participants and staff in their understanding of clinical equipoise and therapeutic misconception |
| Example: Identifies and discusses the two comparators in a controlled clinical trial and why each has been selected. | B2. Consistently apply knowledge of clinical equipoise and therapeutic misconception during the course of the study | Example: Leads the development of an in-service training by interpreting study protocols in relation to clinical equipoise and therapeutic misconception. |
| B3. Recognize, interpret, and seek assistance where required to address participant concerns regarding therapeutic misconception or clinical equipoise | ||
| Example: Identifies during ICF process whether the potential participant truly understands the study is research and does not have a predictable outcome. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Explain the importance of complying with global guidelines and recommendations, as well as local regulations regarding the safety, wellbeing, and rights of all subjects participating in a clinical trial anywhere | B1. Critically appraise and implement within a clinical study protocol, the principles of human subject protection and privacy | C1. Supervise the implementation of activities required to protect a clinical study participant´s privacy, safety, well-being, and rights in a clinical trial being conducted in any region |
| Example: Identifies examples of autonomy, justice and beneficence in the recruitment and consent process for a clinical protocol | Example: Designs recruitment strategies that ensures inclusion of all appropriate populations. | C2. Respond to questions posed by a regulatory body (e.g. IRB.IEC) regarding the methods by which a clinical study protects the privacy and safety of participants |
| Example: Explains to an IRB/IEC the plans for ensuring participant confidentiality for a clinical study being submitted for review. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the historical events which have led to the development of the current informed consent regulations | B1. Recognizethe critical nature of communicating the potential risks or hazards, as well as the benefits of a clinical study, using terminology and a manner that is understandable by the potential study participants during the informed consent process | C1. Implement processes and control measures to ensure human subject protection regulations requirements are met across studies |
| A2. Identify the key documents that ensure the protection of human participants in clinical research (Declaration of Helsinki, Belmont Report, CIOMS, Nuremberg report, ICH guidelines, Investigators Brochure, product label, etc.) | B2. Apply knowledge of the key doctrines and tenets for the regulations and guidelines coupled with available safety information when drafting an informed consent document for a clinical study | C2. Evaluate the informed consent document in relationship to the study protocol to assure that it not only meets current regulations and guidelines but also provides the information needed for a potential study participant to make an informed decision regarding their participation in the study |
| Example: Identifies and explains the three principles of the Belmont Report and the difference between FDA regulations and ICH GCP guidelines. | Example: Composes the informed consent document for a clinical study and includes the potential risks and benefits in an understandable manner for the study participants. | Example: Serves as an effective member of an IRB to ensure human subject protection. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify which populations are considered vulnerable | B1. Accurately applythe appropriate safeguards with research participants | C1. Evaluate a study protocol to identify whether population is properly protected or additional safeguards are needed |
| A2. Understand that regulations are in place to protect vulnerable populations | B2. Anticipate situations when research participants may be considered vulnerable | C2. Create strategies to engage vulnerable populations in research studies to allow them to make the best decision |
| Example: Understands these groups as being vulnerable: children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons and accurately describe additional safeguards in place for each group. | Example: Applies knowledge of vulnerable populations to the subject consent process and identifies vulnerabilities and applies safeguards for participant protection. | C3. Evaluate unique situations that affect participation of vulnerable patients |
| C4. Evaluate whether vulnerable populations require special considerations from IRBs or regulatory authorities | ||
| Example: In a community research study of vulnerable populations, develops strategies that would protect participants during recruitment and retention. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize the cultural variations which exist when conducting multi-regional clinical trials for new investigational product development | B1. Compare and contrastthe ethical principles guiding clinical research across different global regions (e.g., ICH guidelines vs. FDA regulations, other country regulations) | C1. Assure that clinical trials incorporate concepts which recognize varying cultural perspectives and ethical issues across regions |
| A2. Explain the concept of cultural competency and how it relates to the conduct of clinical research in diverse population groups | B2. Examine the pros and cons of conducting clinical trials in low and middle-income countries and differentiate the potential types of exploitation and benefits that populations in these countries may face in the conduct of a global clinical trial | C2. Develop strategies to select clinical trial sites that appropriately balance the need to provide equal access to potential treatments |
| Example: Serves as a contributing member of a global medicines development team. | Example: Recommends that clinical studies will only be conducted where the relevant infrastructure exists (e.g. cold chain storage) and in regions where the products will be marketed. | Example: Researcher designs a global medicine development program that considers the health needs of potential participants and ensures post trial access to investigational product. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize the eligibility criteria for study participants (e.g., that include and exclude subjects) based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions that allows the research team to determine whether the subjects can take part in the study safely | B1. Articulate the necessity for a homogeneous patient population (based on criteria defined in the protocol) and the need for consistency in protocol recruitment | C1. Develop and edit eligibility criteria for new protocol development |
| A2. Determine potential eligibility of study participants for a non-complex study (e.g., registries, survey studies) | B2. Describe the implications of deviations from inclusion/exclusion criteria on data quality and study validity and how results can be generalized to the public | C2. Explain the rationale for choosing inclusion and exclusion criteria based on evidence or previous experience |
| Example: Identifies the inclusion and exclusion and eligibility criteria from a set of sample cases for an upcoming clinical study. | B3. Develop study materials (e.g., guidance documents, recruitment plans) to ensure appropriate application of inclusion/exclusion criteria | Example: Performs an eligibility risk-assessment and risk mitigation plan for new clinical trials and corrective and preventive action strategies for deviations found during routine site audits. |
| B4. Determine potential eligibility of study participants for complex studies (e.g., biomedical or interventional) | ||
| Example: During a study audit, identifies deviations from eligibility guidelines, describes potential consequences, and discusses the required next steps. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize the eligibility criteria for study participants (e.g., that include and exclude subjects) based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions that allows the research team to determine whether the subjects can take part in the study safely | B1. Implement the processes (e.g., inclusion/exclusion, study procedures, adverse event identification and documentation, continuation of the study) that appropriately balance risk and benefit | C1. Develop the processes (e.g., inclusion/exclusion, study procedures, adverse event identification and documentation, continuation of the study) that appropriately balance risk and benefit |
| Example: Identifies known and potential clinical risks associated with a clinical protocol and applies ongoing risk assessment activities during study visits with participants. | Example: Identifies key risk and benefit components that belong in a Strategic Recruitment and Retention plan or in an Informed consent. | C2. Illustrate the risk and benefits principles and methods while designing and/or providing oversight through the selection and management of clinical study subjects |
| Example: Independently constructs a protocol, informed consent, and/or recruitment and retention plan that incorporates the principles and methods of distributing and balancing risks and benefits. | ||
Domain 3: Investigational Products Development and Regulation
Encompasses knowledge of how investigational products are developed and regulated
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the key historical events that took place which influenced the current regulatory environment that exists today (both FDA and internationally) | B1. Demonstrate an understanding of current events that have influenced guidelines and regulatory processes with regards to FDA regulations and guidelines as well as those on a global scale | C1. Predict and/or construct adaptation plans for the new releases of existing regulations and ICH Guidelines |
| Example: Understands why the inclusion and exclusion criteria for women of childbearing potential sometimes exists in a clinical study. | Example: Locates and describes FDA’s guidance on genomics in clinical research. | C2. Support cross-functional team efforts, provide teaching to internal staff, investigators, and other stakeholders about pending or current guidance or regulations, such as the documentation about training planned for updated ICH E6 |
| Example: Creates a risk-based monitoring plan for a new clinical trial to ensure compliance with FDA regulations and ICH GCPs. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify differences between responsibilities of investigators, sponsors, CROs and regulatory bodies | B1. List specific roles and responsibilities for each of the institutions participating in the investigational products development process, (investigators, sponsors, CROs and regulatory bodies) | C1. Evaluate the study protocol to determine the need for collaboration between various institutions/organizations |
| A2. Demonstrate understanding of the role of IRBs in approving protocols, assessing risk, and determining exemptions | B2. Recognize the scope of responsibilities of monitoring organizations like Research Pharmacy, Data Safety Monitoring Boards | C2. Define the roles and responsibilities and manage the relationships between the stakeholders (including patients, participants, and advocates) to assist in the design and conduct of clinical research |
| Example: Describes the role of an investigator as described in FDA 1572 and the delegation of responsibilities from sponsor to a CRO. | Example: Explains the information required and processes used by the IRB in approving protocols, assessing risk, and determining exemptions. | Example: Assesses the need and develops a request for proposal for hiring a CRO to conduct monitoring activities for a multicenter trial. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Understand concepts, major elements and objectives of investigational products development life cycle management process for investigational products | B1. Interpret and execute the concepts, major elements, and objectives of investigational products development life cycle management process for medical products | C1. Evaluate an established or create a strategic investigational products development and life cycle management plan |
| Example: Has a basic understanding of the drug development and approval process and recognizes the need to obtain approval from the FDA to market the investigational products in US. Maintains site’s IP tracking log at, CRFs, and is familiar with IB or Device Manuals. | Example: Uses the FDA website to determine whether a clinical study using investigational products requires an IND or IDE or letter of exemption. | C2. Coordinate an IP development plan with regulatory authorities |
| C3. Distinguish between the regulatory approval processes for drugs, biologics and medical devices | ||
| Example: Develops and formulates a request for orphan drug designation for a new investigational product. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Describe how to access the appropriate regulatory guidance that applies to the development and registrations of IMPs, and the clinical trials process required to register such products in their geographical location. (US-FDA, Europe-EMeA, UK-MHRA) | B1. Describe and apply federal (US, EMA, or other) regulatory laws and guidance during the performance of complex clinical research operations. | C1. Provide oversight and train others in relation to the relevant authority and associated regulatory frameworks, including how these harmonize with ICH GCP Guideline, the approved study protocol, and sponsor study related SOPs to ensure the safety and rights of study participants |
| A2. Demonstrate basic knowledge of Human Subjects Protection and ICH GCP Guideline | B2. Interpret the requirements of ICH GCP Guideline, the approved study protocol and sponsor study related SOPs. | C2. Monitor the progress and assure that conduct of studies at site meets local, national and global regulatory frameworks, and support others to meet such requirements in the conduct of trials |
| C3. Develop and facilitate the implementation of Safety Risk Management plans | ||
| Example: Accesses the relevant guidance in their country for: Informed Consent, Drug Development and approval, IRBs/ECs, Conflict of interest, Investigator responsibilities, Sponsor responsibilities | B3. Execute the development or editing of study related SOPs, reports, and / or submission for the relevant regulatory approval of the study. | Example: Produces training guides, documentation, and checklists to enable study delivery staff to ensure that the relevant regulatory framework is adhered to in relation to specific studies. |
| Example: Describes how regulations and guidance are applied in harmony with ICH GCP requirements, Health Research Authority approvals processes, Research Ethics Committee Approvals and through the comprehensive recording of study related conduct through the maintenance of an investigator site file. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Describe the specific activities and purposes of preclinical and clinical research and how they contribute to the filing of an IND and an NDA/CTA/BLA | B1. Actively participate in the implementation of Phase 1-3 clinical trials | C1. Appraise the potential and resources required for successful implementation of a preclinical or clinical research protocol |
| A2. Recognize how Phase 1-3 data contributes to the filing of an IND and NDA | B2. Differentiate between the purposes of the IND, NDA, BLA and each phase of clinical development and the relationship of research questions answered at each phase | C2. Supervise the development, clinical planning and implementation of a preclinical or clinical research protocol intended to contribute to a regulatory submission (e.g., IND, BLA, NDA) or clinical program |
| Example: Participates in the collection of documents necessary for submission of an NDA. | Example: Uses the investigator brochure to understand and anticipate what types of potential safety risks might be associated with a clinical trial. | Example: Analyzes data and makes a go/no-go decision after Phase I data are analyzed. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the differences between adverse event reporting requirements for studies pre- and post- marketing approval | B1. Assess the occurrence and coordinate with investigator on classification of adverse events during the conduct of a clinical trial | C1. Identify and interpret safety data (e.g., safety signals or data from surveillance systems) |
| A2. Understand the reporting requirements for different types of adverse events | B2. Complete and submit adverse event reports, according to appropriate requirements and timeline | C2. Monitor and teach others to compare and contrast safety reporting requirements that may differ by region |
| C3. Develop and facilitate the implementation of Safety Risk Management plans | ||
| Example: Identifies adverse events that meet the criteria to be labeled ‘serious.’ | Example: Identifies, classifies, and codes an adverse event using source documentation and an appropriate coding dictionary. | Example: 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 agencies with regards to safety reporting. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize that different national regulations may affect the medical product approval process | B1. Compare regional regulations and how their differences could impact the conduct of trials or the review of medical product approvals | C1. Develop and implement strategies for the conduct of multi-regional clinical trials |
| C2. Develop and implement global strategies that optimize the required review and approval of a marketing application | ||
| C3. Analyze the resources necessary to gain approval for medical products in multiple countries | ||
| Example: Recognizes that GCP must be honored in multi-site trials, but that other national regulations may differ. | Example: When conducting a study in Japan, applies appropriate strategies to include the correct number of Japanese nationals as part of your study population, as required by the Japanese regulatory agency. | Example: Knows that a regulatory application in another country may necessitate significantly more resources than a similar application in the US and provides multiple solution alternatives to address barriers to approval of medical products with strategies in alignment with international harmonization efforts (e.g., ICH, EU. WHO). |
Domain 4: Clinical Study Operations (Good Clinical Practice)
Encompasses study management (adverse event identification and reporting, post-market surveillance, and pharmacovigilance), and handling of investigational product.
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the link between developing a new intervention and the interrelated trial goals and design by reading and comprehending a clinical trial protocol | B1. Review and comment on trial protocols to ensure the links between the objective of developing a new intervention and the related trial goal and design is accurate | C1. Design a clinical trial independently to ensure an accurate link between the goal of developing a new intervention and the trial goal |
| Example: Identifies the study protocol methods for avoiding selection bias in a clinical study so that the results are considered reliable and valid. | B2. Provide input and share ideas, proactively and reactively, on trial design | C2. Train, supervise, and coach junior trial designers |
| Example: Reviews and provides substantive editorial comments for a clinical study protocol during its initial development. | Example: Independently designs a feasible clinical trial per applicable regulatory requirements, within budget, to provide proof of unbiased safety and efficacy. |
link to table
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Describe basic principles of GCP | B1. Describe how GCP principles are incorporated into clinical research | C1. Apply GCP Guidelines to the conduct of clinical research |
| A2. Describe own role and is aware of roles of others in the site clinical investigation team as set forth by the institution or organization, regulations and GCPs | B2. Describe roles and responsibilities of IRB and sponsors as set forth in federal regulations and GCPs | C2. Review and assess all roles in the clinical investigation team |
| A3. Understand the concepts of delegation of authority and scope of practice | B3. Perform role in accordance with GCP guidelines | C3. Supervise clinical investigation team members |
| Example: Clearly articulates own role responsibilities and describes limits of one’s role in the performance of clinical study activities. | Example: Accurately identifies and reports situations when clinical investigation team members are not able to fulfill responsibilities and who to contact for support. | C4. Perform audits of clinical research performance to ensure compliance with GCPs |
| Example: Assembles, supervises and manages an appropriate investigational team for multiple clinical research studies |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Following training, describe how the ICH Good Clinical Practice Guidelines are incorporated into the design of a research protocol, the procedures followed during the conduct of a clinical study and the collection of data relating to the study | B1. Successfully participate in the implementation of a clinical research protocol and assure that, with minimal supervision, the ICH Good Clinical Practice Guidelines are being followed during the conduct of research procedures and the collection of data | C1. Ensure that the operationalization of a clinical research study complies with ICH Clinical Practice Guidelines |
| Example: Describes the concepts contained in the Declaration of Helsinki and how they are incorporated into clinical protocols and implemented during research on human subjects to ensure ethical and quality standards are maintained. | Example: Leads a team that is generating and collecting data in a clinical research protocol in a manner that ensures the conduct, reporting and recording of the clinical study is occurring utilizing internationally accepted guidelines. | C2. Appropriately resolve any compliance related issues which arise during the conduct of the clinical study |
| C3. Ensure that the personnel conducting the study are appropriately trained | ||
| Example: Assesses and ensures that ICH GCP compliance is maintained throughout the conduct of a clinical research study and when appropriate mentor and train individuals in the ethical and quality concepts required during the conduct of a clinical research study. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Describe the role of global regulatory bodies in the conduct of clinical studies | B1. Assist in the identification of country-specific regulations which apply during the conduct of a clinical study | C1. Create processes and procedures to determine feasibility for global studies |
| A2. Identify the various global regulatory agencies and their respective country-specific regulations | B2. Apply current processes and procedures for the global regulatory agency application requirements for clinical studies | C2. Determine and schedule the proper regulatory application requirements and timeframes for study applications |
| A3. Recognize the differences in the global regulation of drugs, biologics, and medical devices | Example: Applies knowledge of local and global regulations in performing initial feasibility studies for the conduct of global multicenter clinical studies. | C3. Provide mentoring and educate others on the global regulatory landscape with respect to the identification of potential clinical sites and the initiation and conduct of clinical studies |
| Example: Identifies the differences between the regulations and guidelines in the US and Europe for the development and marketing of investigational medicinal products. | Example: Establishes workflows that promote optimal planning for future clinical study applications, data-sharing and clinical sample acquisition for a global multicenter clinical trial. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Understand that investigational products require specific control, storage and dispensing | B1. Articulate the specific procedures and elements for control, storage and dispensing of investigational product | C1. Develop SOPs that include specific procedures and elements for control, storage and dispensing of investigational product |
| A2. Identify and follow existing Standard Operating Procedures for control, storage, and dispensing of IP | B2. Determine deviations in the process of handling study medication and report /solve the issue | C2. Develop CAPAs when issues in the handling of study medication are detected in order to avoid further deviations |
| Example: Locates and applies an SOP for the receipt, storage and usage of investigational product for a clinical study at the clinical research site. | Example: When given a variety of scenarios, implements maintenance of proper environmental storage conditions, security, inventory control, and IP accountability (ordering, receipt, inventory, disposal, transfer) to ensure adequate and safe supplies for clinical study participants. | Example: Performs audits, generates CAPAs and adjusts SOPs for the management of investigational products according to FDA regulations and GCPs. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize the differences between the different types of adverse events | B1. Differentiate the reporting timelines and requirements for an SAE and SUSAR across various international guidelines (e.g., FDA, EMA, ICH, etc.) | C1. Critique the SUSAR reporting requirements across various agencies and entities and formulate new recommendations to enhance the harmonization of reporting requirements |
| A2. Recognize when an SAE occurs during the conduct of a clinical trial and report it within the appropriate time frame per the regulatory regulations | B2. Execute the reporting of an SAE to the appropriate entity (sponsor, regulatory agency, IRB/IEC) based on their respective role (e.g., investigator, CRA, sponsor) | Example: Investigates the impact of a lack of harmonization of SUSAR reporting requirements on the timeliness of reporting in a global clinical trial and constructs a new SOP to govern reporting requirements for their organization. |
| Example: Applies accurate classification of adverse events from sample cases (AE, SAE, Serious and Unexpected AE, Adverse Drug Reaction, etc.) | Example: Demonstrates an ability to recognize and report an SAE to the appropriate entity within the appropriate time frame during the conduct of a clinical trial. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Understand that human research subjects are entitled to protection and privacy and that global regulations are in place to protect research subjects during the conduct of clinical studies | B1. Apply appropriate protection and privacy safeguards when conducting clinical studies | C1. Create strategies to protect human research subjects and guard their privacy in clinical studies |
| A2. Locate the specific regulations associated with the protection and privacy of human research subjects | B2. Report situations when human research subjects may require protection and privacy | C2. Evaluate whether protection and privacy strategies are appropriate |
| Example: Accurately describes safeguards for human research subject protection and privacy in global, national and local regulations and guidelines. | B3. Recognize the existing global regulations and local rules which differ among countries regarding to protect human research subjects and their privacy | C3. Develop and implement a global investigation strategy with global and local regulations to protect human research subjects and their privacy |
| Example: Describes study visit activities, and identifies actions required for subject protection and privacy appropriate for the regulatory body and regulation for different countries (e.g., CFR (FDA, US), EU directive and regulation (EMA, EU), J-GCP (PMDA, Japan), C-GCP (CFDA, China) and guidelines for privacy protection for research participants. | Example: Plans a new clinical study that includes a comparison of local, national and international health care settings, norms and ethnicities that may impact human subject protection and privacy. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize and understand the rationale for clinical monitoring and the appropriate regulations and ICH guidance that applies | B1. Employ and implement the clinical monitoring plan to complete monitoring tasks/activities | C1. Lead the monitoring effort by mentoring others in the planning and conduct of monitoring site visits |
| A2. Adhere to the monitoring plan and applicable standard operating procedures | B2. Address complex monitoring issues with minimal supervision or guidance | C2. Oversee the creation and planning of study-specific monitoring plans that assure sufficient resources are allocated to ensure timely review of data while maintaining established standards for study participant safety and data integrity |
| A3. With guidance and oversight, perform monitoring tasks per the monitoring plan and inform others when confronted with issues not detailed in the monitoring plan | B3. Provide guidance to others to resolve simple and moderately complex monitoring issues | Example: Creates clinical study monitoring plans, provides leadership, mentoring and guidance to ensure all monitoring activities and workflows are in compliance and are ‘audit-ready’ |
| Example: Participates in local QA audits of clinical studies in preparation of a CRO monitoring visit. | Example: Applies prospective risk-based approaches to ensure quality data and rapid and accurate responsiveness to clinical monitoring queries. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Describe the steps taken to prepare for an audit/inspection | B1. Distinguish between scope of audits conducted by sponsors, IRB and regulatory authority | C1. Supervise preparation for an audit/inspection conducted by a sponsor or regulatory authority |
| A2. Name the entities which have authority to conduct audits | B2. Identify research components inspected during a clinical study audit | C2. Develop policies and SOPs in response to audit/inspection findings |
| A3. Locate and explain the federal regulations governing audits and inspections | B3. Distinguish between routine and for-cause audits and inspections | Example: Given an audit report, creates a comprehensive CAPA plan to respond to audits/inspections, and develop appropriate SOPs. |
| Example: Assists with preparation for clinical study audits and understands roles of the team during an audit. | Example: Given a clinical study protocol, classifies and categorizes the specific information and sources of data required by auditors and inspectors. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Understand that safety is a central issue in clinical trials and that lack of safety oversight can jeopardize participants in numerous ways | B1. Execute safety reporting within required timelines through appropriate channels | C1. Anticipate possible safety issues during the clinical study implementation |
| A2. Recognize the tools and processes implemented in a clinical trial to protect participants | B2. Classify safety issues and report them to regulatory authorities and IRBs | C2. Institute measures to minimize risks |
| A3. Remember to report suspicious activities or events which might compromise safety | B3. Implement international guidelines and requirements across relevant agencies (e.g., FDA, EMA, ICH, etc.) | C3. Critique and improve monitoring and pharmacovigilance plans |
| Example: Identifies safety issues, risk mitigation and action plans for diabetic patient who are required to be fasting for a lengthy study visit. | B4. Relate safety issues according to monitoring and pharmacovigilance plans | C4. Recommend and conduct safety training for study teams |
| Example: Generates SOPs for the handling of safety hazards in the clinical research site and detecting and reporting adverse events. | Example: Example: Develops a CAPA plan and staff training for monitoring findings of under-reported adverse events. |
Domain 5: Study and Site Management
Encompasses content required at the site level to run a study (financial and personnel aspects). Includes site and study operations (not encompassing regulatory/GCPs)
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Demonstrate a basic understanding of baseline determinants of new study selection process at a research site | B1. Provide input and guidance in the study selection process, including the ability to assess financial and logistical feasibility of conducting a study at the research site | C1. Guide study selection on a program or institutional level |
| A2. Understand the purpose of pre-site evaluation visits | B2. Assist in organizing and conducting pre-site visits | C2. Defend study selection decision-making, including determination of scientific validity and value; favorable risk/benefit ratio, and operational (logistical and financial) feasibility |
| A3. Participate in virtual or face-to-face pre-site visits | B3. Assist in estimating budgets for a potential study | C3. Lead the negotiation, creation of tools, guidance documents, and policies to guide the decision-making process in study selection and participation |
| Example: Given a new potential protocol, understands study-related needs in order to be able to do the study at the site, including availability of a specific study population. | Example: Completes a feasibility assessment checklist for a new potential study, including preliminary budget estimates. | Example: Creates a study feasibility tool for use throughout department and evaluate assessments to make recommendations |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the component parts of a clinical trial budget | B1. Critique and recommend changes to proposed business plan, budgets, timelines, outsourcing requirements, and amount/type of personnel necessary to conduct a clinical study | C1. Develop, monitor, and manage the business strategy (e.g. budget, timeline, outsourcing plan, and/or personnel resources) to conduct a clinical study |
| A2. Track functional tasks for external partners. | B2. Monitor milestones (e.g., clinical and financial) and identify trends or risks during study execution | C2. Analyze trends and implement mitigation plans |
| B3. Organize and process outsourcing requirements and reporting (bid defense, proposal development, vendor selection, metrics, financial management and reports) | C3. Manage personnel that is assigned to the clinical study | |
| C4. Lead the vendor selection and management process | ||
| Example: Organizes study visits and requisite labs using correct requisition and account numbers for the study and is able to track and reconcile those documents. | Example: Analyzes a study budget to ensure all requirements of the protocol are included. | Example: Generates amendments to a study budget and milestone timeline to reflect new requirements for an amended protocol and to address unforeseen cost issues for the conduct of a clinical study. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the mechanisms used in a research study that have been put in place to mitigate risk | B1. Monitor the effectiveness of the Quality/Risk Management Plan | C1. Define key performance indicators necessary for the clinical studies and incorporate them into the study specific Quality/Risk Management Plan |
| A2. Understand how risk assessments are conducted for clinical study operations and patient safety | B2. Implement risk mitigation steps as defined in the plan and develop a strategy to educate others on its content and application | C2. Develop and deliver both generalized and study-specific Quality/Risk Management Plan training programs |
| A3. Provide critical data points and/or generate reports that relate to the risk management plan | C3. Interpret internal quality assurance data on key performance indicators and strategize to mitigate risk through a corrective and preventive action (CAPA) plan | |
| Example: Articulates potential reasons why a key performance indicator might be compromised (e.g., study participants not completing study visits within the protocol-defined study window) and operations that might ensure lowest risk of occurrence. | Example: Analyzes reports and implement defined risk mitigation steps when key performance indicators have been triggered. | Example: Analyzes and reports quality audit findings, presents them as discussion topics for mitigation strategies during staff meetings and/or incorporates them as part of quality management training programs to ensure staff understand how a QMS applies to a clinical study. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Articulate expected recruitment and retention rates | B1. Interpret subject recruitment and retention tracking data to determine if changes are needed | C1. Innovate solutions to recruitment and retention challenges incorporating key ethical considerations. |
| A2. Identify and use tools, strategies, and procedures for implementation and tracking of participant recruitment and retention | B2. Develop basic methods for capturing and reporting on recruitment and retention | C2. Propose different recruitment tools specific to regulatory requirements of each region / country |
| A3. Describe local and international regulatory requirements that impact the use of different recruitment tools | B3. Apply local and international regulatory requirements to the use of different recruitment tools | |
| Example: Identifies documents and systems used to track recruitment and retention of participants. | Example: Creates a recruitment plan that addresses the needs of the study population with regards to age, gender, distance, and develops participant fliers for IRB submission that will aid in recruitment. | Example: Given a scenario of a study with fledgling recruitment or retention, the researcher creates innovative solutions that are evidence-based, clearly address the specific needs of hard-to-reach/engage populations. The solution includes plans for frequent review of the success of the strategies |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Organize and maintain study regulatory and grants/contracts documents for regulatory and institutional compliance audits | B1. Organize and appropriately process contracts, materials transfer agreements, budgets, indemnification agreements, confidentiality agreements and conflict of interest reporting. | C1. Monitor systems and collaborate with institutional bodies to ensure compliance with legal and ethical requirements in the conduct of clinical research at the organization. |
| A2. Understand purpose of study legal materials including: contract, budgets, indemnification, confidentiality disclosure agreements, conflict of interest reporting and IRB approvals in a compliant study site | B2. Develop and/or follow SOPs that mitigate legal risks in conducting clinical trials | C2. Develop and critique risk mitigation strategies, associated action plans and issue resolution |
| Example: When asked by an investigator to obtain samples in the freezer to ship to another investigator for a lab-based research project, researcher at the Fundamental Level knows to seek additional advice to ensure that a materials transfer agreement is in place before making the shipment. | Example: Reviews an informed consent form to ensure that indemnification language in the Clinical Trial Agreement is in line with indemnification statements in the protocol and informed consent form and institutional policy. | C3. Negotiate legal contracts (including budgets), confidentiality agreements, and conflict of interest documents |
| Example: Serves on a conflict of interest board for an institution |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the regulations and guidelines that describe the requirements that apply to principal investigators, sponsors, CROs, and regulatory authorities in the conduct of clinical research | B1. Understand and articulate applicable regulations and accurately follow established processes in place to ensure compliance | C1. Apply advanced understanding of regulations and ability to accurately interpret regulatory guidance and mentor others in the translation of regulations into everyday practice. |
| A2. Describe roles of the site team members, including PI; sponsor, CRO, institution and FDA | B2. Describe the various team roles (Sponsor, PI) and their responsibilities in the compliant conduct of clinical research. | C2. Create strategies, policy and procedures to ensure regulatory compliance at a departmental or institutional level |
| Example: Catalogues and files all regulatory documents, including informed consent forms and recruitment materials necessary for an IRB submission. | B3. Describe the impact of compliance on the safe and ethical conduct of clinical research studies | C3. Organize and manage regular study-related meetings with study staff and the principal investigators. |
| Example: Processes an IRB submission for a new clinical trial. | Example: Generates a delegation of authority log that clearly delineates staff roles in conducting a study according to levels of responsibility and scope of practice. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify stages of project management (e.g. Identify, Plan, Implement, Monitor/Control, Close) | B1. Identify critical project success factors for tracking, analysis, and reporting for clinical research project performance | C1. Implement project adjustments and influence future project selection and execution, based on analysis of prior performance |
| A2. Monitor and report critical project success factors or milestones | B2. Compile and analyze, and make recommendations relating to clinical research project performance | C2. Oversee the development of project content across project plans |
| Example: Identifies the basic principles of project management (e.g., scope or deliverables) and relates them to the requirements of a clinical research project. | Example: Defines and develops critical and relevant Key Performance Indicators (KPIs) and metrics for a dashboard presentation. | Example: Shares best practices (e.g., lessons learned) across multiple projects to establish a scalable organizational knowledge base to improve current and future projects by utilizing project performance metrics. |
Domain 6: Data Management and Informatics
Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Understand the basic purpose of statistics and informatics as applied in clinical studies (e.g., randomization, sample size, adverse events, analysis, results) | B1. Perform randomization activities to ensure accurate designation of new study participants | C1. Develop a statistical analysis and data management plan for a clinical study |
| Example: When reviewing a protocol and case report form, recognizes the data points that are associated with analysis of safety and efficacy endpoints. | B2. Describe the statistical requirements to answer the study question (hypothesis) in a study protocol | Example: Develops and annotates a case report form for a clinical trial that will ensure accurate data collection in keeping with the study protocol. |
| Example: Generates descriptive statistics to illustrate enrollment and safety data in a study for a staff meeting presentation. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Describe the basic concepts of clinical data management. | B1. Apply all aspects of the clinical data management plan (CDMP) to an active clinical study 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, EMR transfers, etc. | C1. Create the clinical data management plan for a clinical study |
| A2. Identify the various sources of data that contribute to a clinical study and can distinguish the different industry standards to be used in their handling. | B2. Manage queries and recommend whether the flow and quality of the clinical data meets the standards set in the CDMP. | C2. Analyze and modify standard operating procedures, when necessary to accommodate the inclusion and implementation of new technology in the data management process or new industry-wide initiatives (e.g. data transparency and clintrials.gov requirements or the MRCT initiatives on data sharing, etc.). |
| Example: Understands the purpose and scope, as well as the process workflow defined in a data management plan. | Example: Performs an analysis of the data flow from various sources (e.g., Esource, third-party sources, etc.) to ensure clean data transfers per predefined specifications. | C3. Educate and mentor others concerning their role and responsibility in the conduct and management of clinical data across each aspect of the clinical research enterprise. |
| Example: Participates at an investigator meeting to review the clinical data management process and the responsibilities each PI and site has in the process. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify and apply standard and best practices for data management in clinical research. | B1. Implement industry, federal and GCP accepted standards and best practices for data management in a clinical study. | C1. Develop a data management plan for a clinical study that includes standardized plans for data collection, data capture, data management, data analysis, and data reporting that use industry-accepted standards or best practices. |
| A2. Identify documents and resources related standards and best practices associated with the collection, data capture, data management, data analysis, and data reporting in clinical research. | B2. Perform data management activities across clinical studies from creation of protocol specific source documents, collection and entry of data and performing quality audits | Example: Develops an annotated CRF for a specific study according to the data management plan for that study. |
| Example: When given standardized scenarios, the researcher identifies a standard or best practice (for data collection, capture, management, analysis, and reporting). | Example: Collects and enters data into new electronic data collection forms with timeliness, accuracy and low query rates. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify and understand processes that assure data quality. | B1. Independently ensure compliance with data quality related SOPs | C1. Create/define data quality related SOPs or study-specific procedures for the conduct of a clinical trial. |
| A2. Recognize whether individual pieces of data collected in a clinical study are attributable, accurate, complete and verifiable from the source data. | B2. Provide input and share ideas, pro- and reactively, related to data quality and the related processes. | C2. Advise the data management team on data quality related processes that impact the clinical trial team, ensuring a smooth and constructive collaboration and communication between both. |
| Example: Enters and corrects data from a source document into an electronic data collection form. | Example: Suggests a change in an eCRF design to a sponsor to help avoid recurrent queries. | C3. Train trial staff on data quality related procedures and provide oversight and support in cases of doubt or risk for non-compliance. |
| Example: Generates an eCRF that complies with data quality standards defined by the institution or company. |
Domain 7: Leadership and Professionalism
Encompasses the principles and practice of leadership and professionalism in clinical research
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Display professionalism in the workplace, in attire, attitude, work-ethic, self-motivation and quality products | B1. Assist others with various aspects of study management using effective communication methods and documentation | C1. Serve in leadership roles in the research department |
| A2. Identify the leadership structure of the organization | B2. Train and mentor Fundamental Level staff | C2. Train and mentor new staff members and team members, including performance management |
| A3. Locate, comprehend, and adhere to the standard operating procedures in the research department | B3. Demonstrate effective time management and organizational skill when managing multiple research related projects | C3. manage multiple complex study operations |
| A4. Demonstrate initiative and team cooperation in performing research duties | Example: Plans and conducts a protocol implementation meeting. | C4. Set strategic planning goals and objectives for study performance |
| Example: Arrives at work on time, articulates information in a succinct and appropriate manner both verbally and in writing, and seeks guidance or directions where he/she has questions. | Example: Manages study teams and develops budgets and assists with contracts for clinical research projects. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Explain the nature and historical instances of ethical and professional conflicts which occur in the conduct of clinical research | B1. Recognize, implement, and manage the procedures in a clinical research study which minimize the risks of ethical and professional conflicts | C1. Assess the risk of ethical and professional conflicts inherent in a clinical study |
| A2. Describe the procedures which are implemented to prevent ethical conflicts and support risk management strategies | B2. Implement risk management strategies within their role responsibilities | C2. Develop strategies and policies to implement and manage risk of ethical and professional conflicts across a project team as well as functional domains |
| Example: Describes how the concepts within historical documents (e.g., of the Nuremburg Code, the Declaration of Helsinki, the Belmont Report and the CIOMS International Ethical Guidelines for Research Involving Human Subjects) concerning research ethics are integrated into a clinical research protocol. | Example: Organizes 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 study team. | Example: Appraises the potential risks (both ethical and professional) inherent in the conduct of a clinical research study and develops the framework for risk management for a department or project team. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Recognize the key documents which make up the foundation of the regulations that ensure clinical studies are conducted ethically and in a professional manner | B1. Apply professional and ethical regulations and international guidelines in each facet of clinical research | C1. Evaluate, and modify when required, internal policies and procedures to ensure that the organization’s code of ethical conduct is in compliance with local law/regulations and/or international guidelines |
| A2. Identify and understand the meaning of ethical and professional behaviors found in both federal regulations and international guidelines addressing ethical conduct in clinical studies. | B2. Demonstrate through actions and documentation of tasks during the conduct of clinical research an understanding of how appropriate procedures and processes assure professional and ethical conduct throughout clinical research | C2. Mentor (educate) and provide guidance to all study team and staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted within the bounds of ethical conduct. |
| Example: Identifies the key regulations and guidelines in FDA and ICH documents that ensure ethical conduct in clinical studies. | Example: In day-to-day activities and tasks, demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures, regulations, and guidelines. | Example: Ensures all local and global regulations and guidelines are reflected in standard operating procedures and processes by adapting any established procedures, processes, or workflows to reflect any new or updated regulations and/or guidelines (e.g. training documentation) |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Describe why it is important to incorporate strategies that account for regional and cultural diversity in the conduct of clinical research | B1. Apply regional/country and cultural considerations during study design and conduct | C1. Develop specific strategies or methods for considering culture and region/country when designing and conducting studies in multiple regions/countries |
| A2. Classify examples of potential impact that are related to diversity or cultural competency | B2. Incorporate the appropriate regulatory requirements during the implementation of multi-country trials | C2. Validate that regulatory requirements are incorporated into the study design for multi-country trials |
| Example: Suggests strategies to address diversity and cultural competence for a diverse set of potential participants in a clinical study, including age, ethnicity, race, and gender and religion | Example: Recognizes cultural and diversity issues when developing a research idea into a global clinical study. | Example: Proposes specific strategies that can be employed in each region/country to ensure cultural and regional appropriateness when initiating a new clinical study. |
Domain 8: Communications and Teamwork
Encompasses all elements of communication within the site and between the site and sponsor, CRO, and regulators. Understanding of teamwork skills necessary for conducting a clinical trial.
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Describe and understand the importance of an interdisciplinary team and the values each member can bring to clinical studies | B1. Identify and facilitate the activities of the key contacts essential to ensuring effective team operations during a clinical study | C1. Mentor others regarding how to work best on a multi-functional/matrix clinical study team. |
| A2. Identify and recognize each member of the team and their respective roles and responsibilities and understand that communications within a clinical study team is vital to the success of the study | B2. Demonstrate an understanding of the cross-functional team in developing a communication plan | C2. Establish the core infrastructure of the clinical study team and ensure effective and efficient communication and teamwork |
| B3. Provide team members and stakeholders with timely status reports | C3. Incorporate multidisciplinary skills into research teams | |
| B4. Demonstrate interpersonal skills (e.g. negotiating, influencing, resolving conflict) | C4. Resolve team related issues and evaluate outcome of solutions | |
| Example: Understands the professional roles and clinical practice domains of all members of the clinical study team. | Example: Demonstrates the ability to perform the day-to-day operational activities critical to running an effective team (e.g. setting up meetings, developing a communications plan, identification of key contacts both within the team and outside of the team). | Example: Creates study teams and establishes an operational workflow to implement study team communication, cross-training, ensures training documentation is maintained, and provides guidance when needed in order for them to optimize their effectiveness. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Understand and describe the relationships and appropriate communication channels between regulators, sponsors, CROs and research sites | B1. Apply appropriate professional communication practices in written and verbal interactions with other parties in order to maintain legal, ethical, and productive relationships during the conduct of a research study | C1. Establish and maintain productive long-term relationships with all participating parties across the research enterprise to sustain efficient, effective and sustainable clinical trials currently and in the future |
| Example: Demonstrates appropriate written and oral communication between stakeholders in the clinical research operation | Example: Develops proactive written and oral communication that addresses team related challenges that could impact study execution so that mutually agreed upon solutions can be developed to address the challenges. | Example: Anticipates the needs of all parties participating in the research enterprise and serves as a communication mediator when difficult situations arise that have had previous unsatisfactory results. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Explain the structure and contents of a scientific publication. | B1. Relate the content and value of clinical research studies to colleagues and the non-scientific community through professional presentations and other verbal and written means | C1. Design reports for scientific and non-scientific communities which interpret and explain clinical trial data and appraise the significance of clinical study reports |
| A2. Identify and utilize reliable sources of information which communicate clinical research findings to the scientific and non-scientific communities | Example: Writes lay summaries of research studies for a journal club or to potential patient populations. | C2. Facilitate the awareness and further understanding of clinical research protocols and their results to colleagues, advocacy groups and the non-scientific community |
| Example: Explains the scientific underpinnings of a clinical trial in terms that can be understood by the non-scientific community. | Example: Communicates outcomes of a clinical research study to sponsors, colleagues and the non-scientific community. |
| Fundamental Level | Skilled Level | Advanced Level |
|---|---|---|
| A1. Identify the component parts of a scientific publication and the general purpose of each part | B1. Describe the methods for a study that has been published and appreciates the basis for the conclusions made from the results obtained. | C1. Navigate, appraise, and assess the content of all component parts within a traditional scientific publication and communicate a both detailed understanding to staff |
| A2. Comprehend that a traditional scientific publication describes the outcomes of a research study in a structured and ordered format to contribute to generalizable knowledge and evidence-based practice | B2. Search the literature using key terms to find articles on specific subjects | C2. Describe the relationship of the findings from a clinical study to the relevant human population and current practice context |
| Example: Reviews and discusses a published study associated with an ongoing clinical study protocol. | B3. Explain the difference between a primary source and a secondary source when citing the professional literature | C3. Write and edit manuscripts as well as apply varying journal citation styles when formatting a manuscript |
| Example: Composes an abstract for a publication or professional presentation accurately citing the literature using primary source data (e.g., able to trace a secondary source back to the originating primary source). | Example: Given the results of a clinical study, generates and edits a manuscript and/or responds to editorial comments and suggestions in order to develop a final and accepted professional publication. |
