Electronic Source Data in Clinical Investigations: Guidance for Industry
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Administrative / Procedural, Good Clinical Practice (GCP)
Published
September 18, 2013
Last updated
April 29, 2020
Description
Guidance document providing industry guidelines on electronic source data in clinical investigations, covering administrative and procedural aspects and good clinical practice (GCP).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)