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At the end of a trial it is important to make sure that everything has been properly documented and reported. A study close-out SOP should detail procedures to ensure the following:

  • That all the GCP documents are complete and transferred to a trial document archive.
  • That all the trial drugs or vaccines are returned or destroyed.
  • That a Trial Report is written that captures all the key data, states where everything (including important documents such as participant log, randomisation codes and product batch numbers) can be found. This important document is a complete report on the study and includes all the data, all the intervention details and who took part. It is an essential record of the trial that could be used if anyone needed to go back for any reason to resolve an issue about the trial or one of its subjects.
  • That the results were reported to Ethical Committee, Regulatory Authorities, the community and Ministry of Health or other relevant regulatory body.

To view and download templates for Study Close, such as termination checklists, close-out SOPs, and archival documents, please click on the link to access our extensive Templates Library

  • opgupta opgupta 22 Mar 2017

    Preservation and documentation of all data is necessary so hat it can be retrieved as and when it is required for nau inquiry, reproduction of the trial etc.

    Important results related to trial should be informed to the community/individuals having participated in the trial if it requires continuity of the drugs ar any further management, and to the regulatory authorities