Resources

If you are interested in additional information regarding clinical research, the following links may be helpful to you. We also welcome you to contact us if you have additional questions.

Selecting a CRO

Things to Consider
Evaluation Check List

Independent IRBs

Biomedical Research Institute of America (Biomed)
Chesapeake Research Review, Inc.
Institutional Review Board Services
Quorum Review, Inc.
Research Consultants Review (RCRC)
Sterling IRB
Western Institutional Review Board (WIRB)

Clinical Research Guidance

21 CFR Part 11: Electronic Records; Electronic Signatures
21 CFR Part 50: Protection of Human Subjects
21 CFR Part 54: Financial Disclosure by Clinical Investigators
21 CFR Part 56: Institutional Review Boards
21 CFR Part 312: Investigational New Drug Application
21 CFR Part 812: Investigational Device Exemptions
Clinical Research and the HIPAA Privacy Rule
E6 Good Clinical Practice Consolidated Guidance
FDA Forms
FDA Guidance for Financial Disclosure by Clinical Investigators
FDA Guidance for IRBs & Clinical Investigators
FDA Guidance for Monitoring of Clinical Investigations
FDA/ORA Compliance Program Guidance for Bioresearch Monitoring of Clinical Investigators
FDA CDRH Device Advice
FOI Online
HHS Office for Civil Rights – HIPAA

Professional Associations & Publications

AdvaMed
Applied Clinical Trials Magazine
Association of Clinical Research Professionals (ACRP)
Center for Information and Study on Clinical Research Participation (CISCRP)
Centerwatch
Drug Information Association (DIA)
Food & Drug Law Institute (FDLI)
Orange County, CA Regulatory Affairs Discussion Group (OCRA)
Regulatory Affairs Professional Society (RAPS)
Society of Clinical Research Associates (SOCRA)
The Organization for Professionals in Regulatory Affairs (TOPRA)