I am currently setting up a Phase III CLL non-commercial trial comparing 3 already marketed drugs being tested in new indications.

The trial will involve limited on-site SDV and pharmacy monitoring during the course of the trial. In the interim periods between monitoring visits, should I be requesting sites to send in temperature data for central monitoring or is it acceptable to fully delegate this responsibility to the sites (RSA states site responsibility)?

Also, is it acceptable for sites not to have to inform the Sponsor of temperature deviations if there are clear guidelines in place regarding the storage limits and course of action to be taken i.e. quarantine stock?

Finally, we assume that most sites will standardly perform continous monitoring of IMP storage areas, however, where this is not the case, is there a minimum frequency of recording that a Sponsor should request i.e. twice daily, daily?

I'd be keen to hear what other people's experiences are, from a Sponsor and site pharmacy perspective.

Many thanks in advance.