Frequency of sponsor visits

[clinicalandrew]

Hello,
Is there an expected number of visits by a sponsor or their CRA during a clinical trial? I have heard that it should be approximately every six weeks for an active trial though I guess this may depend on the type of trial. I ask because we have had some difficulty in getting a CRA to visit our site.

Many thanks
Andrew

[ashirve]

Hi Clinicalandrew,

You have the answer in your question! You are perfectly right in saying that the CRA monitoring visit frequency depends on the type and complexity of the trial. This frequency should be determined and documented in the monitoring plan.

Sorry, not very helpful as don't have enough info about type of the trial you are talking about.

[Prof David Hutchinson]

Hi Andrew
There are many factors which determine how frequently a monitor may visit your site. The latest developments suggest that a risk assessment be undertaken and a monitoring plan drawn up by the sponsor. This will document who gets visited and when. If you are doing a low risk study perhaps on a marketed medicine within its marketing authorisation --- nowadays termed Type A -- and are contributing few subjects to the trial it is likely that you are low priority for a visit. That said the sponsor should not ignore your activity and should at least visit in the early stages of the trial to check that things are going ok. If you are conducting a trial on an unlicensed investigational medicinal product you are likely to be visited more frequently. If you have not had any monitor visits then you should make extra effort to make contact with the sponsor to discuss that as they do have oversight responsibilities. You should have been given contact details.
Hope that helps.
David