Revised September 2014
Clinical informatics is the integration of clinical practices and novel information technology, computer science and knowledge management methodologies. Find out how informatics can help researchers accelerate analyses and data exchange, and streamline reporting.
- Computerized Systems Used In Clinical Trials - [FDA web site]
- 21 CRF Part 11 - Electronic Signature and Record (ERES) - [FDA web site]
- 21 CFR Part 820 - Quality System Requirements (QSRs) - [FDA web site]
- General Principles of Software Validation - [FDA web site]
- ICH E9 "Statistical Principles for Clinical Trials" (PDF, 285KB) - [ICH web site]
- ICH E2B(R2) "Data Elements for Transmission of Individual Case Safety Reports" (PDF, 295KB) - [ICH web site]
- ICH E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) (PDF, 819KB) - [ICH web site]
- ICH E3 "Structure and Content of Clinical Study Reports" (PDF, 483KB) - [ICH web site]
Get this Publication
Search for Funding
Discusses the importance of quality mentorship in drug abuse research and offers suggestions for creating a successful mentor and mentee relationship.