Recently asked the following question from a colleague doing a QC Review of CVs:
“So, quite a few of these SubI’s list full Study titles in their CV, including various sponsor names. I always thought this was confidential with Sponsors and shouldn’t be included in a CV – thoughts?”
Should CVs be rejected from the TMF for listing detailed information from previous work as Sub-I?
Is there a regulation that describes in detail what content must be in a CV? Conversely, is there a regulation that identifies content that should not be included? A CV should demonstrate qualifications and experience. Other than this, I’m not aware of other specific regulatory guidance. Any “restrictions” that I’ve seen (eg a 1-page CV) have been sponsor requirements.
Inclusion of other sponsors on a CV may be a confidentiality issue for those sponsors but I don’t think this is a regulatory issue (perhaps a legal one if they’re under a confidentiality agreement!).
I have not seen Sponsors require other company names or study titles to be redacted from site personnel CVs. In my opinion, if the CV includes study information that is already present on Clinicaltrials.gov, it should not be an issue. I agree with Eldin to check the CDA for specific language.
LMK Clinical Research Consulting
Thank you both for your comments. They are in line with my opinions and will help to confirm guidance communication to our team. We strive for 100% compliance, and this forum has certainly helped us maintain that goal.