Originally Posted by
a123456
Here are some useful references:_
European Medicines Agency (EMA) GCP Inspectors Working Group. Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials,(Final), 09 June 2010.
Clinical Data Interchange Standards Consortium (CDISC) e-SDI Group. CDISC Standards and electronic
Source Data within Clinical Trials, 20 November 2006.
Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry – Computerized Systems Used In Clinical Investigations, May 2007.
Food and Drug Administration. 21 Code of Federal Regulations Part 11 – Electronic Records, Electronic Signatures.
Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics
Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, December 2009.
Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) in support of Clinical Research Addressing Regulatory Considerations (Release 1.0), 2 April 2009. Electronic Health Records for Clinical Research (EHRCR) Working Group
FDA Guidance for Industry Electronic Source Documentation in Clinical Investigations draft guidance Dec 2010