Hi all,

We would like to investigate using our current 3rd party ePRO capture system for MHRA regulated trials but would appreciate your thoughts on the below setup. We use a system for our academic trials where patients have the option to complete QoL data direct online. Data is stored within our institutions ringfenced server.

Of concern,
1. Site (or anyone) have no access to the response data. Data is extracted at the end of a study or for interim meetings, for sponsor viewing only.
2. Once completed and saved by the pt, the data can not be amended by the patient (or anyone)

Looking into GCP/ MHRA requirements, I am concerned this set up is not compliant.
I would appreciate your thoughts.

Thank you,