If you missed the first part in this series, you can find it here.
Nearly all sponsors use EDC technologies. Let’s zoom in for a closer look at a simplified example.
312.62(b) requires investigators “to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation …. Case histories include the case report forms.” Part 312 makes no allowance for investigators to delegate these obligations.
EDC providers create software that have databases and user interfaces allowing users to design eCRFs, enter data, run automated edit checks, issue queries, monitor data, and manage users. They host the servers on which the application runs and data are stored, but are not involved in any of the data management activities.
Sponsors contract with EDC providers to use their software. Sponsors design the eCRFs in the system to collect the protocol-required data; program intra- and inter-form edit checks, test the system, deploy it for use; train the users; and manage user access.
Investigator sites use the EDC system to enter protocol-required data into the eCRFs. When they save an eCRF, a record is created in the EDC provider’s database.
Because the sponsor has not delegated any of their responsibilities to the EDC provider, the EDC provider is not a CRO.
However, both the sponsor and the EDC provider have a role in ensuring that once an eCRF record is created by investigator site staff, it is maintained in such a way that it is still adequate and accurate, is available to the investigator, and is retained for the record retention period.
- The records are not under the investigator’s control
- The investigator has no contractual relationship with the EDC provider
- Both the sponsor and the EDC provider have users with elevated privileges
- The sponsor may be making self-evident corrections to the investigator’s data
- The sponsor controls user access to the investigator’s data
You could make the case that the sponsor has transferred some of the investigator’s responsibilities to themselves and to the EDC provider.
How does this affect regulatory enforcement? In part three, we will show certain observations that, well, feel weird. Take a look here.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, InspectorProfiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at firstname.lastname@example.org.
About the Author
Jamie Colgin is Govzilla’s GCP Product Manager and is the recipient of the prestigious Charles H. Butler Excellence in Teaching Award. She joins Govzilla from Colgin Consulting, Inc.