As the clinical research world becomes increasingly technologically advanced, we have seen more and more sponsors choose to use Electronic Data Capture (EDC) Systems to document Case Report Form (CRF) data. FDA published a guidance in September 2013 to address the questions associated with this growing trend.
This guidance document outlines the recommendations from FDA “to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations”. Specifically, the following topics are discussed:
- Identification and specification of authorized source data originators
- Creation of data element identifiers to facilitate examination of the audit trail (by sponsors, FDA, and other authorized parties)
- Ways to capture source data into the eCRF using either manual or electronic methods
- Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data
- Use and description of computerized systems in clinical investigations
Specifically worth mentioning is Section B.1a, titled Clinical Investigator(s) Review and Electronic Signature; this section states that “to comply with the requirement to maintain accurate case histories clinical investigator(s) should review and electronically sign the completed eCRF for each subject before the data are archived or submitted to FDA”. In addition, Section B.2 further explains that “if changes are made to the eCRF after the clinical investigator(s) has already signed, the changes should be reviewed and electronically signed by the clinical investigator(s)”. The guidance does go on to note that some data can be exempt from investigator review (such as in the case of a blinded study, or specifically administrative data); in these cases, this data should be listed in the data management plan as being exempt.
In our experience at IMARC, we have seen instances where the investigator may not be signing off on eCRFs (or signing off on changes to eCRFs after they originally signed). However, we have also known several sponsors who have moved towards the direction of utilizing EDC systems for their CRF data, in order to make the process of principal investigator sign-off more efficient and standardized across the study sites. It is interesting to see how companies are starting to change their processes to reflect this new guidance.
How do you feel about the topic of PI signoff on eCRFs? What has been your experience with sites or sponsors complying with this requirement?
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