Where to look

Please refer to the following standards and initiatives that are driving the industry:

Standards

• GCP
  Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
• CDISC
  Clinical Data Interchange Standards Consortium
• FDA 21 CFR Part 11
  Code of Federal Regulations for Electronic Records and Electronic Signatures
• FDA GFI "Computerized Systems used in Clinical Trials
  Guidance for Industry "Computerized systems used in clinical trials" .

 

Initiatives

• FDA Critical Path Guideline
  The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product.