Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11--Questions and Answers; Draft Guidance for Industry; Availability

Documents

Comments

Key Dates

Comment Period OpensJun 21, 2017

Comment Period ClosesMay 16, 2023

Type	Title	Posted	Comments	Status
Other	Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers - Guidance for Industry	Oct 2, 2024	2

Total Comments

CDER

2013-622

Use of Electronic Records and Electronic

Signatures in Clinical Investigations Under

21 CFR Part 11--Questions and Answers

Draft Guidance for Industry

Availability

OPEN