Good Clinical Practice
Good Clinical Practice - A Guide to Archiving Page 5 3 Roles and Responsibilities 3.1 Sponsor Prior to initiating a trial the Sponsor should define, establish and allocate all trial related duties and functions. In relation to material retention, the Sponsor should: Agree the format in which all records will be maintained
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A Guide to Archiving Electronic Records
the-hsraa.orgArchivist: An individual designated by management to be accountable for the management of the archive, i.e. for the operations and procedures for archiving. Electronic archive: The designated repository in which electronic records are retained for their long term preservation. Electronic Document and Records Management System (EDRMS): A
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www.ema.europa.euThe ICH GCP guideline provides information in relation to essential documents to be collected during the conduct of a clinical trial. The risk-based approach to quality management also has an impact on the content of the TMF. To ensure continued guidance once the Clinical Trials Regulation (EU) No. 536/2014