Clinical Trial Compliance Guide: FDA Requirements

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Clinical Trial Compliance Guide
FDA Requirements

The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies.

If you had to pull all of them together yourself — and get the right version — it would take you hours.

But, the FDAnews editorial staff has put in the hours so that you don’t have to. Over 35 of the FDA’s most crucial guidances on clinical research have been compiled for you.

Clinical Trial Compliance Guide is your searchable, one-stop source of all the FDA’s clinical trial-related guidances. This management report includes:

  • How to report adverse events to your IRB
  • How to establish and operate data monitoring committees
  • How to react to investigator misconduct
  • Investigational New Drug (IND) and Investigational Device Exemption (IDE) requirements
  • What to expect from an FDA inspection
  • Rules for working with in vitro diagnostic devices

The guidances cover:

  • Adverse Events
  • Biologics
  • Data Management
  • Electronics and Software
  • GMP/GCP
  • HDEs and HUDs
  • INDs and IDEs
  • Informed Consent
  • International Conference on Harmonisation
  • Investigators
  • Medical Devices
  • Trial Sponsors
  • Trial Management

A sampling of this collection includes:

  • Financial Disclosure by Clinical Investigators
  • Determining Whether Human Research Studies Can Be Conducted Without an IND
  • Informed Consent — Questions and Answers
  • In Vitro Diagnostic Device Studies — Frequently Asked Questions
  • Electronic Source Documentation in Clinical Investigations
  • Waiver of IRB Requirements for Drug and Biological Product Studies
  • Acceptance of Medical Device Clinical Data from Studies Conducted Outside the US
  • Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review
  • ICH E3 – Structure and Content of Clinical Study Reports

Order your copy of Clinical Trial Compliance Guide: FDA Requirements — the digital manual you can search to find the clinical trial information you need.

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Who Will Benefit

  • Clinical investigators
  • Site managers
  • Regulatory affairs staff
  • Research and development department
  • Lab managers

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