21st Nov 2011, 05:02 PM
Central Monitoring of IMP Storage
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.
25th Nov 2011, 01:01 PM
The responsibility of the temperature monitoring can be delegated to the site. It is difficult/impossible for the sponsor to keep an eye on the temperatures on day to day basis. It is not uncommon to delegate this responsibility to the site.
In my opinion, site should inform the sponsor if the storage area temperature go out of the range even if there are clear steps to deal with it. By this way sponsor can appropriately assess the situation can come with action plan if necessary.
It is always desirable, however not always possible, to have a means of continuous monitoring in place. If it is not possible, then sponsor has to decide the frequency. The frequency may have been mentioned in the site SOP so you can have a look at that as well. Normally 4 times a day would be sufficient to give you the clear picture of the storage temperature conditions. You may also want to think about outsourcing the 'continuous monitoring device' to the site on temporary basis.
Hope this helps.
2nd Aug 2012, 02:10 PM
I would suggest providing Temptale devices to the site (not very expensive), and these continuously monitor and can be downloaded monthly and printed out for you to view, or sent to you by PDF on email.
It is the sites responsibility to monitor the temperature and maintain quality of the IMP, have SOPs for quality deviations, temp monitoring and recall.
Usually it is the Sponsor who authorises the site to release IMPs after a deviation, after checking with the QA dept. (QP) that the stability is acceptable, particularly important is tracking multiple exposures to out of spec temperature as some medicines may not be reused after several exposures to incorrect storage conditions.
This can be risk asessed if you are using licensed products which are stored at room temperature for example, from experience Sponsors will (in this case) write clear instructions in a Pharmacy manual what to do in case of deviation of temperature, and under which circumstances the product may be released again for use, the robustness and documentation of these events is tested on inspection.
My opinion is based on experience from inspections and setting up the Pharmacy support of many many protocols