Clinical Trials

Clinical trials is research typically involving human participants and would require IRB review and approval.

Original Contributor:
Bruce Steinert, Evanston Northwestern Healthcare Research Institute

1. 42 CFR 411 Exclusions from Medicare and Limitations on Medicare Payment (Federal Self-Referral (Stark I) Regulations) 
2. 42 CFR 414 Payment for Part B Medical and Other Health Services
3. 42 CFR 422 Medicare+Choice Program
4. 42 CFR 424 Conditions for Medicare Payment
5. 42 CFR 1001 Program Integrity – Medicare and State Health Care Programs (Safe Harbors in §952)
6. 48 CFR 25 Foreign Acquisition
7. 48 CFR 852 Solicitation Provisions and Contract Clauses
8. Council on Government Relations (COGR)

Sub Categories:

SOPs

• International Organization for Standardization (ISO)
• ISO 10993-1:2003 Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing    (There are 20 parts overall) 
• ISO 14155-1:2003 Clinical Investigation of Medical Devices for Human Subjects, Part 1: General Requirements 
• ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects, Part 2: Clinical Investigation Plans (Draft #6)  
• ISO 14971:2000 Medical devices - Application of risk management to medical devices
• ISO15225:2000  Nomenclature - Specification for a Nomenclature System for Medical Devices for the Purpose of Regulatory Data Exchange   
• SO/TR 16142:1999 Medical devices - Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices
• ISO/WD TS 19218 Medical devices -- Nomenclature and System for Adverse Medical Device Event Reporting 
• NIH Grants Policy Statement (December 2003)

1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Registration  (Approved for use through 01/31/2008)
2. Federal wide Assurance (FWA) for the Protection of Human Subjects 
3. Federal wide Assurance (FWA) for the Protection of Human Subjects for International (Non-U.S.) Institutions
4. Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement Date: January 31, 2005 :
5. Guidance on Reporting Incidents to OHRP (May 27, 2005)
6. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Authorization Agreement (01/06/2005)
7. IRB Guidebook 
8. OHRP Staff Telephone Numbers and E-Mail Addresses – Alphabetically 
9. OHRP Staff Telephone Numbers and E-Mail Addresses – Organizationally 
10. Format for All NIH IRB Minutes
11. Industry Directories 
12. IRB Forum
13. Guideline for Good Clinical Practice 
14. Canadian Association of Research Ethics Boards (CAREB) 

United States

• 21 CFR 3 Product Jurisdiction
• 21 CFR 25 Environmental Impact Consideration
• Food Drug and Cosmetics Act (As amended by  FDAMA, 1997)  
• Medical Device User Fee and Modernization (MDUFMA) of 2002   
• 10 CFR 35 Medical Use of Byproduct Material                                      
• Circular A-21 Cost Principles for Educational Institutions 
• Circular A-87 Cost Principles for State, Local, and Indian Tribal  Governments
• Circular A-102 Grants and Cooperative Agreements with State and Local Governments
• Circular A-110 Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations
• Circular A-122 Cost Principles for Non-Profit Organizations 
• Circular A-133 Audits of States, Local Governments, and Non-Profit Organizations 
• FirstGov.gov (U.S. government web portal)
• GPO-Access (CFR and Federal Register)
• Patient Safety Data Sharing and Protection from Legal Discovery 
• Premarket Approval Applications
• Abbreviated New Drug Applications (ANDA) 

International

• Canada
  • Canadian Association of Research Ethics Boards (CAREB)  
  • Health Canada  
  • Health Products and Food Branch 
  • Guidance for Records Related to Clinical Trials GUIDE-0068
• European
  
  • Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (20 June 1990) 
  • Directive 93/42/EEC European Union Medical Device Directive (MDD), 12 July 1993
  • Directive 2001/20/EC on the approximation of the laws, regulations and administrative   provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
  • Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as   regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
  • Human Medicines (European Medicines Agency; EMEA)
• International Conference on Harmonisation (ICH)
  • E2A Clinical Safety Data Management: Clinical Definitions and Standards for Expedited Reporting
  • E2B Data Elements for Transmission of Individual Case Safety Reports
  • E3 Structure and Content of Clinical Study Reports
  • E6 Guideline for Good Clinical Practice
  • E7 Studies in Support of Special Populations: Geriatrics
  • E8 General Considerations for Clinical Trials
  • E11 Clinical Investigation of Medicinal Products in the Pediatric Population
  • M4 Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Business Development

• Health Resources and Services Administration
• NIAID Policy: Investigator-Initiated Clinical Trials (NOT-AI-05-021) 
• NIH Roadmap 
• Resources for New Investigators 
• Compliance Program Guidance for Pharmaceutical Manufacturers (April 2003)
• OIG Compliance Program Guidance for Pharmaceutical Manufacturers (FR 68 (86): May 5, 2003 p. 23731- 43) 
• Pharmaceutical Industry Profile 2004 (Washington, DC: PhRMA, 2004). Used with permission.
• Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results :
• CenterWatch Drugs in Clinical Trials Database
• Innovation.org (searchable PhRMA drug development databases) 
• Pharmaceutical Research and Manufacturers of America (PhRMA)
• Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research (May 2005) 
• PharmaLive eNewsletters

Sub Categories:

Sub Categories:

IRB Submission and Review

• Belmont Report  
• OHRP Inspection Findings (July 2002)
• Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 (“407”) Review Process (May 26, 2005)
• Public Responsibility in Medicine and Research PRIM&R      
• NIH Grants Policy Statement (December 2003)
• Complaint - Gelsinger v Trustees of U. Penn., et al

Other

• Form 1571 Investigational New Drug Application (Instructions)
• Form 1572 Statement of Investigator (Instructions) 
• Form 3454 Certification: Financial Interests and Arrangements of Clinical Investigators
• Form 3455 Disclosure: Financial Interests and Arrangements of Clinical Investigators
• American Society of Hospital Pharmacists   
• ASHP Guidelines on Clinical Drug Research   
• ASHP Guidelines for Pharmaceutical Research in Organized Health-Care Settings

1. Introduction to the Responsible Conduct of Research 
2. Association of Clinical Research Professionals (ACRP)
3. Society of Clinical Research Associates (SoCRA)
4. Society of Research Subject Advocates 
5. Veteran’s Administration – “Program for Research Integrity Development & Education”