When a monitor has a tiny epiphany while working through a difficult compliance issue with a site, or an ‘Ah-ha!’ moment, we call that a ‘Regulation Revelation.’ After reviewing an informed consent that lacked the required statement regarding registration on clinicaltrials.gov (21 CFR 50.25(c)), I discussed it with the sponsor and had an ‘Ah-Ha!’ moment I’d love to share.
While just about all new trials are required to be registered on the website, not all are required to have the statement in their ICFs! At least, that’s what one sponsor informed me of when I asked about a site lacking the statement (for a study investigating a 510(k) approved device, so the study is considered post-market).
It was their understanding that (almost) all studies need to be registered on clinicaltrials.gov (unless the sponsor objects), but not all studies need this statement about clinicaltrials.gov in their site's informed consent forms. In order for this statement to be required, one of the major criteria is that the device is subject to 510(k), PMA, or HDE requirements.
In the study we were discussing, the device has already been 510(k) cleared and is a post-market approved study, so it was felt that this statement was not required in the site's consent forms.
I was directed to this document (page 4 in particular), which discusses how ‘Applicable Clinical Trials’ is defined:
- More information can also be found here: http://clinicaltrials.gov/ct2/manage-recs/fdaaa
Since 21 CFR 50.25(c) requires the statement to be included in informed consent forms for ‘Applicable Clinical Trials,’ it makes sense that the NIH (and probably many sponsors) have done some thinking on what that really means.
For this particular study, most sites HAD included the statement, but one of my sites did not. According to this sponsor’s opinion, the consent does not need to be revised. This was indeed an “Ah-ha!” moment for our team and sharing experiences from the field with colleagues is an effective way to provide ongoing training for monitors, particularly regarding regulations that are often difficult for sites to understand. Feel free to download our whitepaper “Regulations Revelations” which shares more of these “Ah-Ha!” moments.
We would love to hear about your thoughts and experiences with this statement (or lack of statement) on informed consent forms for various kinds of clinical trials!
Photo Credit: T.Young