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Compliance In Focus
Posted by Sandra Maddock on Wed, Nov 21, 2012

New FDA Draft Guidance: Electronic Source Data

Electronic Source DataAs technology evolves, it is only natural that there will new ways to consider doing the same task. FDA is catching this wave of the future with the new FDA Draft guidance titled, “Electronic Source Data in Clinical Investigations.” As this draft guidance promotes the electronic age we’re evolving into, FDA hopes this will assist source data overall in clinical research.

As noted on Federal Register news-release, capturing source data electronically should help to:

  • Eliminate unnecessary duplication of data
  • Reduce the possibility for transcription errors
  • Encourage entering source data at the time of a subject's visit
  • Eliminate transcribing source data before entering the data into an EDC system
  • Promote real-time data access for review
  • Ensure the accuracy and completeness of the data

With all of these hopeful advantages to capturing source electronically, FDA wanted to promote this with the new draft guidance by FDA, the following topics are covered:

  • Identifying and specifying authorized source data originators;
  • Creating data element identifiers to facilitate sponsors, FDA, and other authorized parties in examining the audit trail of data;
  • Capturing source data into the eCRF using either manual or electronic capture methods;
  • Investigator responsibilities with respect to reviewing and retaining electronic data

This is something our industry has been moving toward for quite a while. Whether it’s from the notion of “Going Green in Clinical Research Trials,” or just the next wave of the future, more and more sites are moving towards the utilization of electronic records. While this may be an exciting transition, certain challenges may develop in trying to monitor electronic regulatory compliance.

How do you think this will change the regulatory environment? Are you in support of this electronic leap forward? Voice your concerns, or excitement, below.

Photo Credit: Onion

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Topics: Electronic Source Data, FDA Draft Guidance, Federal Register


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