1. Validating electronic source data in clinical trials;Marks, RG;Control Clin Trials,2004
2. Food and Drug Administration. US Department of Health and Human Services. ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), March 2018. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1.
3. Food and Drug Administration. US Department of Health and Human Services. Electronic Records; Electronic Signatures, 21 CFR §11 (1997). Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm.
4. Food and Drug Administration. US Department of Health and Human Services. Guidance for Industry: Computerized Systems Used in Clinical Investigations. May, 2007. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations.
5. Food and Drug Administration. US Department of Health and Human Services. Investigational New Drug Application; Investigator recordkeeping and record retention, 21 CFR §312.62 (1997). Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm.