Human Subjects Questions, FDA Answers

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Human Subjects Questions, FDA Answers

FDAnews’ staff has culled through questions submitted to OGCP about human test subjects and curated more than 100 of the most relevant responses for you — segmented by category.

Some of these may be questions you’ve asked yourself and others you may not have even thought of. But all of them get straight to the heart of your role as a clinical trial professional — how to conduct safe, effective, compliant trials that can win FDA approval.

This collection sheds light on some of the most difficult and important topics in clinical trial research, including:

  • Exact wording of informed consent forms (ICF)
  • Witnessing signature of ICFs
  • Procedures for re-consenting subjects
  • Potential HIPAA violations
  • Research-related injury
  • Collecting information on pregnant subjects
  • Communicating with unresponsive subjects

This book also includes copies of documents and other resources most often recommended by OGCP:

  • Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.
  • Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c) (Small Entity Compliance Guide)
  • Screening Tests Prior to Study Enrollment
  • ICH E6 — Good Clinical Practice: Consolidated Guidance
  • Informed Consent Information Sheet
  • Data Retention When Subjects Withdraw from FDA-regulated Clinical Trials

Get answers to human subject questions clinical research professionals ask of OGCP.

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Who Will Benefit

  • Researchers/investigators
  • Manufacturers’ R&D departments
  • Hospitals’/medical centers’ clinical trial heads
  • Consultants
  • Laboratory managers
  • Legal counsel

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