Guide to Informed Consent Compliance
The FDA considers informed consent an ongoing process rather than a signed-and-done deal with trial participants. Investigators must be in constant communication with subjects to ensure that their consent is truly informed at every step of the trial.
With dozens of guidance from the FDA and HHS’ Office of Human Research Protections (OHRP) that explain what the agencies expect, navigating the rules and procedures for protecting participants in clinical trials is challenging.
Are you up to speed on the Belmont Report, the Revised Common Rule and ICH E6(R2) – Good Clinical Practice Guideline?
To make sure you know all the rules of the process, Guide to Informed Consent Compliance contains more than 30 FDA and OHRP documents that explain in detail what the agencies expect. You’ll get guidance on:
- Data retention when subjects withdraw from FDA-regulated clinical trials
- Emergency use of an investigational drug or biologic
- FDA inspections of clinical investigators
- IRB continuing review after clinical investigation approval
- IRB waiver or alteration of informed consent
- The use of clinical holds following clinical investigator misconduct
- Use of investigational products when subjects enter a second institution
- Informed consent exceptions for emergency research
Human subject protection is the top priority in clinical research, and the FDA and OHRP have many rules to follow. The Guide to Informed Consent Compliance compiles all resources needed to conduct compliant informed consent in one volume. Order your copy today.
Who Will Benefit
- Regulatory/compliance staff
- Principal investigators and trial staff
- Clinical operations and research managers
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