FDA Draft Guidance on:

Electronic Source Data in Clinical Investigations


Congratulations to FDA for the draft guidance on Electronic Source Data For Use in Clinical Investigations. This well-written guidance document clearly addresses the approaches needed for transitioning from the paper case report form (CRF) to the electronic world of the eCRF. This guidance is intended to be used together with the FDA guidance for industry on Computerized Systems Used in Clinical Investigations.


In an effort to streamline and modernize clinical investigations, the FDA has provided recommendations to sponsors, Contract Research Organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. The guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data. The guidance also addresses source data from clinical investigations used to fill the predefined fields in an electronic case report form (eCRF), according to the protocol. The guidance discusses the following topics related to electronic source data:


1. Identifying and specifying authorized source data originator

2. Creating data element identifiers to facilitate examination of the data audit trail

3. Capturing source data into the eCRF using either manual or electronic capture methods

4. Investigator responsibilities with respect to reviewing and retaining electronic data


As always, we will have some comments which will be posted on the FDA website no later than January 19, 2013. However, on first review, the document says it all. Footnote 3 on page 2 is very helpful to clarify the point that: “Investigators are required to maintain adequate and accurate case histories that record all observations and other data pertinent to an investigation under 21 CFR 312.62(b) and 21 CFR 812.140(a).”


From the Target Health perspective, the draft guidance document is fully consistent with our approach to the “paperless” clinical trial. Target e*CTR® (Target eClinical Trial Record, the electronic health record for clinical trials), will be the eSource records used for the first NDA submission to use a “paperless” approach for clinical data, and the 2nd NDA submission (1st one approved in 2012) to use Target Document® to manage the electronic Trial Master File (eTMF) for regulatory documents.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com


Leave a Reply

You must be logged in to post a comment.