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Good Clinical Practice (GCP) Questions and Answers - Quality Management System




Developing a Clinical Trial Quality Management System and SOPs for new Sponsors 

Sponsor is establishing quality management system according to ISO 9001:2008 requirements. So they will have SOPs only in relation to ISO requirements, but not specifically for clinical trial conduct (e.g. site selection, monitoring, safety, data management, GCP audit,). Is it sufficient for outsourcing purposes and delegation of responsibilities if they select CRO & vendors based on their "generic" SOP on vendor selection and qualification, and then in the contract to state that SOPs of contracted parties will apply for the specific scope, or should sponsor develop clinical trial conduct SOPs as well? 

Ref: MS05 Date: 22nd May 2014


All sponsors conducting clinical trials usually adhere to ICH E6 on GCP.  This has specific Sponsor requirements, as you say, for the activities of clinical trials.   As you will see below (ICH reference) it is the sponsor who is responsible for ensuring that trials are conducted to GCP, by the use of written SOPs.  However as long as the Sponsor can definitely ensure that the trials are conducted in compliance with GCP, the exact specification as to the content of SOPs is up to the Sponsor. 

Hence Sponsors, who outsource a lot of trial activities, have a core set of SOPs including (but not limited to) SOP on SOPs, Training, Oversight of Clinical Trial CROs & Vendors, Fraud & Misconduct as well SOPs covering safety reporting from clinical trials and urgent safety measures. 

It would be impossible to conduct trials via a vendor if there was no mechanism (SOPs, oversight process, co-monitoring, audit, etc.) to ensure that the trial was conducted to GCP.  When outsourcing it is extremely important to make sure that the contract and oversight plans, detail what SOPs the vendor will be following and hence what SOPs will be used by the sponsor to ensure that the vendor is being compliant.  Areas where there could potentially be gaps include be period safety reporting and serious breach reporting.  If these are not explicitly delegated then the sponsor would need SOPs for this. Provided that oversight safeguards are in place, there is no problem in having vendors working to their own SOPs. The MHRA GCP Guide (2012) has a whole section on vendors with more details.   You will have to examine your existing Sponsor SOPs to see if they cover sponsor responsibilities detailed in the legislative requirements of the countries that you are conducting the trials in and guidance such as ICH GCP.  If your "generic" SOP on vendor selection, qualification and oversight covers the GCP requirements, then there is no problem in using them.  Most Sponsors have clinical trial specific SOPs on the use of vendors.

In summary it is acceptable to rely on the vendor SOPs for the conduct and reporting of all aspects of the clinical trial, however the sponsor would need to be very specific to ensure that all delegated aspects are clearly laid out and agreed at the start. 

Reference ICH E6: Sections 5.1.1 and 5.2