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Role, responsibility and reference to EMA (On GCP discussion forum I was asked to place the question here)

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  • Lise
    18/11/2020 14:56
    Can anyone please make a reference in EMAs guideline (E6 R2) and/or reflection paper on GCLP to the following, that a colleague told me was stated at the RQA e-learning introduction to GCLP: An Analytical Project Managers is responsible for the clinical results of a study and must sign off, to indicate the correctness of the data and GCP-compliance. What is the definition of that role? In our setup (as a CRO) we do have a project manager (PM) who is responsible for the co-ordination of activities associated with the clinical project. We also have an analytical responsible scientist (ARS) who is responsible for the clinical results of a study and who signs off, to indicate the correctness of the data and GCP-compliance. I say, that in our set-up it is only the ARS who must sign off and not the PM. I would like a comment from the RQA or other with reference to the guideline and/or reflection paper
  • peter smith
    15/01/2021 08:38
    I respect the government's decision very much. learning too
  • Dominique Chesnais
    19/01/2021 07:57
    The responsibilities of the Analytical Project Manager are stated in the GCLP document, section 5.2. They are quite comparable to the ones of the study director described in GLP guidelines. Their roles are fully inclusive of the whole laboratory project, from its planning to its finalisation, far beyond the limited roles and responsibilities assigned to the analytical responsible scientist (ARS) in your CRO. The Analytical Project Manager is not responsible for confirming the GCP-compliance, as they have no involvement in the trial at sites, limited to the conditions of collating and receiving the biological samples. They can only confirm the GLP-compliance.
  • RQA GLP Committee
    15/02/2021 13:12
    Dear Lise, In section 6.1. Organisation - The analysis or evaluation of clinical trial samples should be overseen by a named individual(s) who assumes responsibility for the conduct and reporting of the work. This individual(s) should ensure that all laboratory work is performed in compliance with the clinical trial protocol, clinical trial protocol amendments, the contract, any associated work instruction and standard operating procedures.
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