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FDAnews’ staff has culled through hundreds of questions posed to OGCP and curated more than 175 of the most relevant of 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:
Dealing with protocol deviations
Investigator responsibilities
Communicating with trial subjects
Inspections of clinical investigators and sites
Monitoring investigators
Submitting information to ClinicalTrials.gov
Good documentation practices
Laboratory certification
Randomization procedures and unblinding
IND waivers
Recruitment advertising
This book also includes copies of documents and other resources most often recommended by OGCP:
ICH E6: Good Clinical Practice Consolidated Guidance
Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators
Informed Consent Information Sheet
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
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 GCP questions clinical research professionals ask of OGCP. Order your copy today.
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