When is a CRO not a CRO? And why does that make enforcement hard?
(Hint: it’s all about delegation.)
What do the following companies have in common?
- Electronic data capture (EDC) software providers
- Central image / electrocardiogram (ECG) / spirometry readers
- Central clinical labs
- Electronic patient reported outcome (ePRO) software providers
- They’re not Clinical Research Organizations.
That’s right. They’re not CROs.
When you finish reading this, you’ll be able to:
- Tell the difference between a CRO and a clinical service provider who is not a CRO
- Explain why enforcement (in the U.S.) is challenging
- To understand why they’re not CROs, let’s step in the time machine
Once upon a time…
Investigator site personnel recorded observations about clinical trial subjects in paper medical charts. Lab work was performed and interpreted at a local lab; X-rays and ECGs were taken and interpreted locally; and results were sent back to the investigator.
Site staff transcribed the relevant data onto paper CRFs, which were triplicate, carbonless forms. When the sponsor’s CRA monitored the site, a complex process of source data verification and data corrections began, all of which was recorded on paper forms, and all of which was visible to the investigator.
The CRA turned one copy of the carbonless CRFs into the sponsor’s Data Management department. The sponsor’s data entry staff performed double data entry into a clinical database. This process in turn generated additional queries that were managed on paper forms shared back with the site.
Sometimes the sponsor delegated some of their responsibilities to other people or companies. This included responsibilities like monitoring, writing protocols and clinical study reports, and managing clinical trial data.
This is the world into which 21 CFR Part 312 was born.
21 CFR Part 312
Sponsors were allowed to delegate their responsibilities to CROs, as long as that delegation was well-documented. Clinical investigators were nearly equal partners with their pharma sponsors. Clinical investigators controlled their data.
The investigator’s recordkeeping responsibilities covered in 312.62 not only made sense: they were reality.
The investigator’s recordkeeping responsibilities still make sense, but reality has changed.
Sponsors have transferred some of the investigators’ obligations to themselves and to these clinical service providers.
In part two, we will take a closer look at EDC technologies. See it here.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at email@example.com.
About the Author
Jamie Colgin is FDAzilla’s GCP Product Manager and joins us from Colgin Consulting, Inc.
She is the recipient of the prestigious Charles H. Butler Excellence in Teaching Award.