Clinical Investigator Questions, FDA Answers

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Clinical Investigator Questions,
FDA Answers

FDAnews’ staff has culled through questions submitted to OGCP about investigations and curated more than 90 of the most relevant responses for you — segmented by category — saving you the time and frustration of sifting through the questions and responses.

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:

  • Investigator responsibilities
  • Home visit protocols
  • Transfer of obligations on the IND application
  • Listing satellite sites and laboratories
  • Use of multiple IRBs
  • Foreign clinical studies
  • Financial disclosure

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

  • Sample copies of Form 1571 — Investigational New Drug Application, Form 1572 — Statement of Investigator and Form 3455 — Disclosure: Financial Interest and Arrangements of Clinical Investigators
  • Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators
  • Elaboration of Definitions of Responsible Party and Applicable Clinical Trial
  • Determining Whether Human Research Studies Can Be Conducted Without an IND
  • Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

Get answers to your investigation related GCP 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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