Hi everyone,

I'm looking for your advice and experience please.

Access to our eCRF database is tightly regulated, with all sponsor users listed on the trial specific sponsor delegation log and the user access request (read only) being signed off by appropriate trial team memeber.

Are there regulations, or concerns from the MHRA regarding,

1. eCRF database user access requests are signed off by a member of the team, usually TM, listed on the delegation log with role defined as 'authorised to sign off to eCRF database'. Would there be concerns over the current TM signing the user access request for another TM? e.g. when handing over the study to a new TM within the organisation
2. Occasionally within our organisation there is a need for TMs/DMs listed on sponsor delegation logs to cover for another trial team. This means that there can be a few TMs/DMs listed on each delegation log, each with user access granted to view the eCRF database. Is this acceptable?

We regularly audit the users whoi have access to ensure they are still appropriate.

I would appreciate your experience and thoughts.

With best wishes