eSolutions to Meet FDA Requirements to Maintain Adequate Records (Part 1 of 6)

This post is Part 1 of a 6 part series. Visit weekly or enter your email to subscribe. 

Technology is important in the product development life cycle as well as the clinical trial workflow. The regulations are flexible in allowing sponsors and CROs to choose electronic solutions for data collection either home grown or vendor purchased. In any case, however, the electronic systems should meet the sponsor needs and the sponsor should vet and document the system capabilities and functionality. First let’s define the “e” terms.

to be continued….

  1. Guidance for Industry Electronic Source Documentation in Clinical Investigations Draft Guidance. U. S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner. November 2012. Retrieved December 18, 2012 at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf
  2. CDISC Clinical Research Glossary.  Applied Clinical Trials 20(12): 11-43. 2011.
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