Comments from RQA GCP Committee:-
quality agreements typically have content that covers who does what & when for
1. Audits – by the Sponsor/third-party and by the CRO, including sharing of planned audits, audit outcomes and follow-up
2. Inspection – of the Sponsor, of the CRO/its vendors and of investigator sites
3. Quality Issues – usually significant, mainly focussed on issues at sites & CRO/its vendors but sometimes at sponsors where there is actual/potential impact on CRO tasks
a. Special language for escalation, management and reporting of potential serious breaches, USM, etc
For 1-3, there would be definitions of the threshold for sharing issues & findings with the Sponsor.
4. Quality Metrics – often included. Sometimes reported via a general governance framework at the executive and, usually, operational level. If not, the shared directly between quality groups CRO-Sponsor.
5. Communication – how the quality groups meet and interact regularly
Another source is AVOCA . https://www.theavocagroup.com/qtl-faq/