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Signing of Study Plan Amendment



  • Marion
    25/10/2020 09:23
    OECD No.1 8.1 Study Plan states: 1. The study plan should be approved by dated signature of the Study Director The study plan should also be approved by the test facility management and the sponsor, if required by national regulation or legislation in the country where the study is being performed. 2. a) Amendments to the study plan should be justified and approved by dated signature of the Study Director and maintained with the study plan. Although it does not state this in the above, but is it good practice to have the sponsor sign the study plan amendment considering that the amendment may be in relation to the change of the conduct of the study and therefore supersedes the original plan? Also how would the study be affected if the sponsor does not sign the amendment?
  • RQA GLP Committee
    20/11/2020 09:03
    Dear Marion, It depends where you are in the World. Some countries mandate that a Sponsor signature is required, (In some countries the COVID pandemic has meant this requirement has been waived). In the UK it is not mandatory, so check local regulations. However, it would be a good idea to have the Sponsor at least approve the amendment, as this indicates that they are supportive of the changes being made to the study. GLP states that the Study Director must have control of the study and therefore the sponsors agreement for the facility (and therefore the SD) to conduct the study should give the study director the permission they need to be able to conduct the study in the way they see fit.
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