1. Sentinel Training at the FDA; Public Workshop
The FDA is announcing the following public workshop entitled ‘‘Sentinel Training at FDA.’’ The purpose of the public workshop is to provide training to understand the kinds of questions that
can be asked using health care claims data generally and within the FDA Sentinel System specifically, allowing an understanding of the capabilities of the Sentinel System.
The public workshop will be held on July 10, 2017, from 10 a.m. to 4 p.m. at FDA’s White Oak Campus in Silver Spring, MD.
Registration is free and based on space availability.
2. Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Guidance for Industry
This guidance clarifies, updates, and expands upon recommendations in the guidance for industry Part 11, Electronic Records; Electronic Signatures – Scope and Application that pertain to clinical investigations conducted under 21 CFR parts 312 and 812.5 Thus, this guidance is limited to outlining the scope and application of part 11 requirements for clinical investigations of medical products.
The goals of this guidance are as follows:
- Update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations
- Clarify and further expand on the risk-based approach described in the 2003 part 11 guidance to validation, audit trails, and archiving of records
- Encourage and facilitate the use of electronic records and systems to improve the quality and efficiency of clinical investigations