Consortium of Academic Program in Clinical Research

Domains of Proficiency and Areas of Competency to be Utilized in the Development of Core Curricula for Academic Programs in Clinical Research

The Consortium of Academic Programs in Clinical Research (CoAPCR) is comprised of academic institutions which offer degree programs for current and future staff members of the clinical research enterprise. The group has developed this set of core competencies using a modified Delphi approach that included input from current clinical research core competency publications, CoAPCR member faculties, specialty groups and stakeholders to serve as a guide for the development and evaluation of clinical research curricula at academic institutions offering these degrees and certifications.

DRAFT DOCUMENT: October 29, 2012

I. Scientific Concepts and Principles of Research Design

Cognitive Domain Psychomotor Domain Affective Domain 1. Demonstrate a basic knowledge of medical 1. Demonstrate the use of library database 1. Discuss how a researcher’s behaviors and terminology, anatomy, physiology, public software to conduct a focused literature review attitudes can be a threat to internal and external health, and, pathophysiology on a research topic. validity of studies 2. Demonstrate a general knowledge of 2. Outline the advantages and disadvantages of 2. Discuss potential conflicts between clinical and pharmacology observational and experimental research research roles for various researcher positions 3. Demonstrate the ability to critically read designs and understand the professional literature of 3. Give examples of common sources of bias tell your field how they are threats to internal and external 4. Identify clinically important questions in validity your field 4. Calculate basic descriptive statistics for central 5. Compare and contrast clinical care and tendency and dispersion clinical research roles for healthcare 5. Outline a research protocol professionals 6. Explain how a research question effects study population selection, design, outcome measures and size of study 7. Describe the sampling or randomization process for clinical study protocols 8. Describe sources of bias in clinical research 9. Define different types of end points in clinical studies

1 10. Define basic statistical terminology 11. Describe the components of a statistical analysis plan 12. Define basic epidemiological terminology and distinguish between odds ratio, relative risk, hazards ratio and attributable risk 13. Identify appropriate information sources for a review of literature 14. Explain what is meant by evidence based medicine 15. Explain the difference between systematic reviews and meta-analyses 16. Critically analyze and discuss study results 17. Define comparative effectiveness research, outcomes research and health services research

II. Medical Product Development Cognitive Psychomotor Affective 1. Discuss the history of governmental regulation 1. Locate, explore and discuss content of 1. Appreciate the differences between country of drug, biologics, devices and food websites for FDA departments (CBER, CDER, regulations 2. Interpret significant historical clinical research CFSAN, and CDRH) and ICH, EMA and other 2. Discuss potential conflicts in product laws and guidelines international regulatory agencies development in cross-national studies 3. Describe the roles of sponsors, partners and 2. Apply regulations for a mock study using a stakeholders in medical product discovery product that has a combination of drug, device and biologic. 4. Define and distinguish between the different centers and offices of the U.S. FDA: especially CBER, CDER, CFSAN, and CDRH 5. Explain the organization and structure of the EMA and other international regulatory agencies 6. Describe the International Conference on Harmonization (ICH), the process for its development, and its impact on global clinical research 7. Compare the clinical processes which lead to drug and device approvals 8. Describe all four phases of drug development

2 9. Discuss good Laboratory Practices (GLP) and GCP regulation for the preclinical and pre- marketing phases 10. Describe the IDE process 11. Identify reimbursement issues related to device development 12. Discuss issues for combined drug, biologic and device studies 13. Identify all pertinent regulatory authorities and organizations which develop standards for drugs, biological, and devices 14. Define efficacy, safety and effectiveness 15. Explain the difference between quality control and quality assurance 16. Describe post-marketing studies and safety reporting systems 17. Describe pharmacovigilance planning 18. Describe the global expansion of clinical research and the issues relating to the conduct of global clinical trials 19. Describe the difference between prescription drug advertising and nonprescription drug advertising 20. Describe what orphan drugs are and discuss appropriate uses 21. Identify typical stakeholder cycle in the drug development process (i.e., consumers, drug company, non-governmental organizations, manufacturers, pharmacies, etc.)

III. Ethical Considerations and the Responsible Conduct of Clinical Research

Cognitive Psychomotor Affective 1. Describe the significance of historical abuses 1. Conduct an internet search to identify past and 1. Discuss the historical and cultural perspectives on the evolution on principles of human subject current ethical abuses in clinical research. which relate to human subject protection protection in clinical research 2. Provide documentation of GCP and IRB 2. Describe the ethical issues involved in the 2. Identify the key documents relating to the certification from CITI recruitment of vulnerable research participants ethical conduct of clinical trials 3. Discuss barriers and facilitators of informed 3. Describe strategies for fairness in recruiting consenting

3 participants and distribution of benefits and 4. Identify and discuss evolving ethical conflicts burdens in clinical research based on issues related to genetics, internet, 4. Describe the mission, function and procedures community, gender, students and race/ethnicity of the institutional review board/ethics in research. committee 5. Describe the informed consent process for adults, children and vulnerable populations 6. Discuss requirements for privacy protection 7. Identify programs developed by the Council for International Organizations of Medical Sciences (CIOMS) 8. Describe responsibility of researchers in addressing health inequities, disparities and involvement of vulnerable populations 9. Describe appropriate considerations for standards of care, tissue banking, and dissemination of research results

IV. Clinical Study Operation and Regulatory Compliance

Cognitive Psychomotor Affective 1. Describe the roles and responsibilities of the 1. Complete an FDA Form 1571 and 1572, 1. Discuss case studies that identify privacy various clinical investigation participants and assemble required documents that issues in clinical research (investigators, institutions, government, private accompany each. sites, and pharmaceutical industry, patients, 2. Prepare a diagrammatic representation of health care consumers) as determined by the organization of the ICH Common Technical Good Clinical Practice guidelines Document 2. Evaluate Clinical Trial Design, conduct and 3. Obtain HIPAA compliance certification from documentation required for compliance with available public or institutional online training ICH GCP’s courses 3. Identify the content that must be included on 4. Assess a study protocol for feasibility as the various forms required by the FDA for IND related to sponsor and site requirements and NDA submissions 5. Match adverse events to MEDRA reporting 4. Compare and contrast the similarities and terminology differences between US FDA regulations, ICH Develop a site response to an FDA 483 Good Clinical Practices and the European 6. Clinical Directive letter and an associated SOP/training plan. 5. Describe how study populations are specified in 7. Screen sample patient records for inclusion a clinical research protocol in a mock study protocol 6. Compare the regulatory requirements for

4 protection of human subjects as described in Titles 21 and 45 of the US Code of Federal Regulations 7. Differentiate between regulations and guidelines 8. Discuss the financial disclosure requirements of investigators 9. Discuss HIPAA and its relevance to clinical research 10. Describe the regulatory requirements and elements of an informed consent document 11. Describe requirements for ensuring proper collection and processing of clinical research specimens 12. Describe IND safety reports 13. Describe drug accountability requirements 14. Distinguish between adverse events and serious adverse events 15. Identify the basic types of post-marketing alert reports 16. Describe the role of the Data Safety Monitoring Board 17. Describe MEDRA and other database systems that can help identify safety signals 18. Differentiate between sponsor audits and regulatory inspections 19. Evaluate a FDA warning letter, and identify appropriate corrective action 20. Describe Phase IV marketing studies 21. Discuss the regulatory approach to developing and registering combination products 22. Describe the FDA’s accelerated Drug Approval/Expanded Access Programs

V. Study and Site Management

Cognitive Psychomotor Affective

5 1. Describe sponsor requirements for 1. Develop an investigator meeting agenda 1. Identify different perspectives of stakeholders in investigator/site recruitment, selection, 2. Develop a recruitment plan for a sample clinical research initiation, monitoring and termination protocol 2. Discuss time management issues in managing 2. Identify the components of investigator’s 3. Develop a study budget associated with a site operations meetings sample study protocol 3. Discuss relationships between monitors and 3. Describe methods for recruiting and retaining 4. Evaluate proposals from several clinical site study personnel clinical research participants research vendors 4. Describe investigator/site methods for deciding 5. Develop job descriptions for monitors and whether or not to participate in a clinical trial project managers 5. Describe requirements for investigator 6. Develop job descriptions for study coordinators interaction with the IRB/IEC throughout the Describe the application of an interactive voice conduct of the study 7. response system (IVRS) as it relates to 6. Identify and explain materials required for product randomization, accountability and essential regulatory documents ordering 7. Describe the sponsor requirements for product 8. Develop a CRA visit report and follow-up packaging and management correspondence 8. Describe the requirements for product 9. Develop a time and events schedule for study management and accountability at the site start-up through reporting 9. Describe requirements for vendor selection and oversight 10. Describe site requirements to prepare for sponsor visits (initiation, monitoring, audit, closeout) 11. Discuss methods for monitoring participant compliance/adherence 12. Describe the requirements of a CRA site visit trip report and follow up letter 13. Describe the use of clinical research software to recruit subjects and manage clinical studies 14. Describe preparations for study close-out and long term archiving of records 15. Describe the procedure for breaking the blind 16. Describe the roles and responsibilities of project managers in clinical research operations

VI. Data Management and Informatics

Cognitive Psychomotor Affective

6 1. Describe the typical flow of data throughout a 1. Develop a diagram to describe a clinical trial 1. Discuss process issues in assuring accurate clinical trial protocol and the flow of data data capture in a clinical trial. 2. Discuss various data collection and data 2. Develop and explain an example of a relational 2. Explain the purpose of best practices for data capture procedures database using excel for a small descriptive management for new study site staff 3. Describe the processes and standards for application approving and maintaining the data 3. Perform an audit and associated report of management plan sample case report forms and clinical data 4. Describe electronic data capture (EDC) and the 4. Perform an audit of case report forms and importance of information technology in data database output for secondary audit of data collection, capture and management 5. Demonstrate basic computer aptitude and the 5. Discuss the process for review, resolution and ability to use Microsoft Word, Excel, tracking of data errors PowerPoint and internet utilities. 6. Describe the ICH GCP requirements for data correction and queries 7. Describe the required components of a Data Quality Assurance Plan 8. Describe the procedures for database lock and understanding the concept of “frozen data” 9. Describe the process for unlocking a database 10. Describe the regulatory requirements and procedures for data archival

VII. Communication of Scientific Data

Cognitive Psychomotor Affective 1. Discuss the relationship and appropriate 1. Assemble a literature review on a focused topic 1. Discuss the writing process and issues for communication between the Sponsor, CRO 2. Critique a journal article or grant proposal novices beginning to develop scientific and the clinical research site communication materials such as abstracts, Develop an annotated bibliography of selected 3. posters and manuscripts. 2. Explain the peer review process for key references using a standardized citation publishing a research paper method and paraphrase. 2. Identify and discuss examples of plagiarism 3. Describe the data requirements for a 4. Write an abstract 3. typical research publication 5. Develop a scientific poster using a standard 4. Describe the advantages and template disadvantages of different ways of presenting Develop a presentation on findings from a data (listings, tables and graphs) in a typical 6. research publication focused literature review

7 7. Prepare content for a draft manuscript for peer editing and publication using a standardized citation method (e.g., APA formatting) 6. Develop a table and figure according to publication requirements.

VIII. Professionalism, Teamwork and Leadership

Cognitive Psychomotor Affective 1. Define concepts of interdisciplinary, 1. Demonstrate understanding of how to 1. Discuss the impact of cultural diversity and the multidisciplinary and translational research coordinate meetings involving personnel with need for cultural competency in the conduct of 2. Identify the ethical and professional issues differing responsibilities and skill sets in the clinical research clinical research process (conflicts of interest, plagiarism, authorship and 2. Discuss the ethical and professional issues 2. Demonstrate an understanding of techniques intellectual property) associated with clinical (conflicts of interest, plagiarism, authorship and for negotiation and problem solving. research intellectual property) associated with clinical Participate in team-building activities in a 3. research 3. Discuss the impact of technology on medical clinical research setting Discuss examples of scientific misconduct and research, education and patient care 4. Develop an ePortfolio that illustrates 3. 4. Identify professional codes of ethics across knowledge, achievement, activities and fraud disciplines (Nursing License, Medical License, samples of work in clinical research 4. Develop a personal statement on professional Pharmacy License) 5. Demonstrate the ability to utilize critical thinking ethics and behavior as a clinical researcher 5. Identify human resource issues in hiring and skills in a professional setting evaluating personnel across groups (industry, 6. Evaluate a project to develop the scope of institutional) work, provide accurate cost estimates, plan 6. Define leadership and the application of various tasks, and allocate resources leadership values across disciplines 7. Identify project management principles as they relate to clinical trial project planning