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:
Electronics and Software
HDEs and HUDs
INDs and IDEs
International Conference on Harmonisation
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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PDF Edition — $397
Who Will Benefit
Regulatory affairs staff
Research and development department
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