The following MHRA Moderator comment is provided in relation to the comments about archiving above:
The UK Clinical Trial Regulations (SI 2004 No. 1031, as amended) don't go into detail about records relating to archiving. However, it is important that the sponsor maintains records of the trials conducted and the archive arrangements for the TMF for those trials, particularly if the organisation sponsors many trials and an external archive facility is being used. Removal of the records from the archive is anticipated to be a relatively rare occurrence and the records should track documentation to and from the archive facility (particularly important where contract archives are being used) and, where appropriate, such as, for large organisations, location of the documentation on site when temporarily removed from the archive. The process should be controlled or overseen by the named individual responsible for archiving.