The following are some references to the US Food and Drug Administration regulations covering computer systems used in a clinical research setting.
- 11 - Electronic records; electronic signatures
- 50 - Protection of human subjects
- 54 - Financial disclosure by clinical investigators
- 56 - Institutional Review Boards
- 310 - New drugs
- 312 - Investigational new drug application
- 314 - Applications for FDA approval to market a new drug
- 58 - Good laboratory practice for nonclinical laboratory studies
- 210 - Good manufacturing practice in manufacturing, processing, packing, or holding of drugs
- 211 - Good manufacturing practice for finished pharmaceuticals
Note that the GxP regulations (GCP = Good Clinical Practice, etc.) are the core of the predicate rules referred to in the scope guidance.
- 820 - Quality System Regulation