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Essential Documents

Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all the applicable regulatory requirements.

Essential documents are the ones which will be reviewed during any audit or inspection to confirm the validity of the trial conduct and the integrity of the data collected.

Essential documents are filed in the Trial Master File (TMF) at the coordinating centre and in individual Investigator Site Files (ISF) at each centre. For Clinical Trials of Investigational Medicinal Products (CTIMPs) a Pharmacy File index is also available.

Warwick CTU's Warwick CTU's SOP 11 - 'Essential Documentation' details how the TMF and TSF's should be set up and maintained. SOP 11 also provides index templates for the Trial Master File, Investigator Site Files and Pharmacy Files. The Chief Investigator (or their designate) is responsible for the creation and maintenance of the TMF which should be held in a secure location and only made accessible to authorised personnel. - 'Essential Documentation' details how the TMF and TSF's should be set up and maintained. SOP 11 also provides index templates for the Trial Master File, Investigator Site Files and Pharmacy Files. The Chief Investigator (or their designate) is responsible for the creation and maintenance of the TMF which should be held in a secure location and only made accessible to authorised personnel.

The PI at each site is responsible for the maintenance of the Investigator Site File and it's subsequent archiving at the end of the trial.