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Clinical Quality Agreement

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  • Mar
    14/12/2020 11:14
    Dear GCP committee. We currently outsource all of our clinical trial activity to vendors (CROS) and as such need to have in place (other than MSA/Work Order/CDA) a Clinical Quality Agreement. Can anyone recommend where i may be able to find such document as i have not been successful in locating anything that would help me develop the agreement. Many thanks
  • Dominique Chesnais
    14/12/2020 15:32
    You can refer to a good article "10 Key Ingredients For Small Pharma GCP Quality Systems" at https://www.clinicalleader.com/doc/key-ingredients-for-small-pharma-gcp-quality-systems-0001, which might be a good starting point to your objective.
  • Colin Wilsher
    14/12/2020 16:50
    Clinical Quality Agreements differ but they usually state what quality standards the vendor will work to. They also usually have a section on quality metrics that will be generated during the contract (a Dashboard). For instance, with a CRO conducting Risk Based Monitoring there are quality metrics that can feedback and adjust the RBM. This helps the sponsor with their risk based management of the CRO. ESTABLISHING A QUALITY AGREEMENT https://www.lifescienceleader.com/doc/quality-agreements-in-clinical-development-a-road-map-toward-a-successful-partnership-0001 METRICS ARE IMPORTANT https://www.lifescienceleader.com/doc/measuring-quality-in-clinical-trials-why-you-re-probably-doing-it-wrong-0001 TransCelerate BioPharma has got lots on quality. http://www.transceleratebiopharmainc.com/wp-content/uploads/2016/01/TransCelerate-RBM-Position-Paper-FINAL-30MAY2013.pdf.pdf
  • Aldwin Aldana, MS, RQAP-GLP, MRQA
    14/12/2020 20:53
    The Society of Quality Assurance has a Clinical Quality Agreement template available for members-only.
  • Colin Wilsher
    15/12/2020 12:17
    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/
  • Mariem
    15/12/2020 12:20
    Wow, thank you so much everyone that is really helpful. I'll check out the links hopefully might be able to find a template that i can effectively work with.
  • Aldwin Aldana, MS, RQAP-GLP, MRQA
    15/12/2020 14:08
    Send me a PM and I'll send you the GCP Quality Agreement from SQA.
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