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Sponsor asking for CRO Monitoring SOPS

By Nicodemus Kisengese posted 05-02-2013 12:57 PM

  

We were recently awarded a contract to monitor a clinical trial which sponsored by two organizations. We agreed that we will use our SOPs to monitor the study. Recently I received an email from one of Sponsor representatives requesting for our SOPs copies. Is it in order to provide our internal documents to them?, especially controlled documents like SOPs?  Your thoughts and guidance will be highly appreciated.
 Regards

Nick

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Bonnie Miller
05-29-2013 04:23 PM

Sponsor SOPs should indicate CRO SOPs meet or exceed their quality expectations, contract should indicate sponsor review and approve/not approve CRO SOPs for the delegated work.

Laurie Emmert
05-22-2013 04:44 PM

Hi Nick,
Yes, this is not unusual for a Sponsor to request a copy of the SOP's if you have already been awarded the contract. If you have a signed contract, You can send them a copy of your SOP's with each SOP stamped as "uncontrolled copy". Hope this is helpful to you... Laurie E. Quality Assurance Auditor

Edgar Smeets
05-07-2013 07:24 AM

Hi Nick,
This can be acceptable indeed. How else could a sponsor judge if your QMS is appropriate for the work?
However, you could offer to be sitting face to face with them, when allowing them to review the actual SOP documents. This might take away your concern that you are disclosing internal documents.
Regards, Edgar Smeets