The FDA requires clinical trial sponsors to report any patient’s serious adverse drug reaction if the sponsor determines that the “information qualifies for reporting” under section 312.32 of its Investigational New Drug Application rules. A lot rides on that simple four-word phrase including:
What are the qualifications?
How does the sponsor report?
What is the deadline for reporting?
What should the report include?
And most important…
What are the consequences of failing to report?
You’ll find the answers to those questions and many more in the 2017 edition of Clinical Trials Adverse Event Reporting Guide. The completely revised and updated guide includes more than 300 pages of FDA guidance on adverse event reporting in areas such as:
Good pharmacovigilance practice
Collecting safety data in late-stage investigations
Reporting to IRBs
Reporting to the Office for Human Research Protections
Creating clinical trial data monitoring committees
Don’t let your clinical trial fail just because you don’t know the reporting rules. They’re all in the guide. Here are a few titles you’ll see:
Safety Reporting Requirements for INDs and BA/BE Studies
OHRP Guidance on IRB Continuing Review of Research
Conducting a Clinical Safety Review for a New Product Application
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions
Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations (NEW in the 2017 edition)
Safety Assessment for IND Safety Reporting (NEW in the 2017 edition)
You’ll also find the text of 21 CFR Part 312, the regulations governing the IND program.
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