Essential documents are documents that allow, individually and collectively, to evaluate the completion of a test and the quality of the data produced. These documents are used to demonstrate compliance by the examiner, sponsor and monitor with standards of good clinical practice and all applicable regulatory requirements. The documentation produced at the time of the administration of the PMI to the subjects must clearly indicate the identity of the product administered to each subject, unless it is a blind study. There are several ways to properly document this management, so it is important for the ability to reconstruct the clinical trial that the location of the original protocol is clear. The identification list, which documents the source data, is primarily designed as a tool for observers, inspectors and inspectors in their work to verify that the review is being conducted in accordance with the GCP guidelines, the applicable legal provisions and guidelines, as well as the experimental protocol. Compliance with the requirements of the protocol with regard to the conditions of administration must be documented: quantity of water with PMI, administration in the state fed or drowned, postures, etc. The PAG task force expects investigators to be aware of the location of the source data and to record it consistently. The planned site should be clearly defined prior to the applicant`s hiring. One way to do this is to generate a list of source data storage locations. This list should be compiled by the website and signed and dated by the lead investigator or by a person to whom the lead investigator has entrusted this task. The list must be deposited in the examiner`s analysis file.
The site should develop an SOP for good documentation. This SOP should be shared with the sponsor/CRO and agreed before the start of the study. This SOP should address aspects, including, but not limited, of consent, authorization verification, the use of instruments such as diaries, source document sheets, OPD documents, copies of prescriptions, etc.; Ways to avoid multiple datasets and, in the case of multiple datasets, to define the source of the study, the method of correction, the verification of security laboratories and other reports.