Hi all, looking for comments from our experienced clinical research redditors!

I am working on a study where medication withholding is necessary prior to screening visit for assessments performed at screening visit. As such, it makes sense to consent subjects ahead of screening visit, because you can't ask subjects to withhold medication until they are consented. The protocol does allow for screening visit to be split over multiple days, but it is not necessary, and potentially a barrier to recruitment and enrollment if subjects meet the washout for medications and screening can be performed over 1 day.

Study team is saying that consenting must occur at screening visit. it is listed under V1/Screening on the Schedule of activities and mentioned briefly that as soon as subjects are consented they enter the screening/run in period. The subjects also have weekly diaries, and study team says that as soon as they are consented, we are following subjects.

I have a site that is strongly pushing back against this, saying that screening and consenting are independent processes. Especially in this study's case, making consenting required at V1/screening visit makes a big barrier for recruitment (since V1 will likely always have to be split over multiple days so that subjects can meet medication withholding criteria for required assessments). It is already a small subject population and now we have another huge barrier for recruitment, I am really turning into the bad guy with this site.

What has your experience been with screening visits and consenting?