Clinical Trials Adverse Event Reporting Guide: 2017 Edition — PDF
The FDA requires clinical trial sponsors to report any serious adverse drug reactions if the sponsor determines that the “information qualifies for reporting” under section 312.32 of its Investigational New Drug Application rules.
- What are the qualifications?
- How does the sponsor report?
- What is the deadline for reporting?
- What should the report include?
- 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 FDA guidance on adverse event reporting in areas such as:
- Good pharmacovigilance practice
- Investigator responsibilities
- Collecting safety data in late-stage investigations
- Reporting to IRBs
- Reporting to the Office for Human Research Protections
- Creating clinical trial data monitoring committees
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
- Safety Assessment for IND Safety Reporting
You’ll also find the text of 21 CFR Part 312, the regulations governing the IND program.
Who Will Benefit
- Site managers
- Trial sponsors
- Principle investigators