Electronic Source Data in Clinical Investigations: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 18, 2013
April 29, 2020
6d72d592-c70b-47f5-810c-0542a685c1b5
Related Documents
Drug-Induced Liver Injury: Premarketing Clinical Evaluation
Guidance DocumentJuly 29, 2009Center for Drug Evaluation and Research
Systemic Lupus Erythematosus --Developing Medical Products for Treatment
Guidance DocumentJune 22, 2010Center for Drug Evaluation and Research
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry
Guidance DocumentJuly 19, 2018Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox