Source Data Agreement Form

These measures should only be implemented by authorized staff qualified through education and training. Source verification is an important part of the work of observers, inspectors and inspectors. To understand the importance of good source documentation, we must first verify the purpose of source documentation. The main purpose of documenting the sources in a clinical trial is to reconstruct the study as it took place. It should allow an independent observer to confirm the data again. Documents must be designed to provide an audit trail to allow for review where necessary. The clinical documentation includes a large number of documents from different sources and is often supplemented by several people. This complicates this process and poses challenges to meet the requirements. In addition, clinical research takes place over a long period of time, which highlights the challenge of maintaining continuity in documentary practices. 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.

Procedures documented at the site level should include managing, maintaining, archiving and consulting source documentation. Sites should have measures to improve and maintain quality data. Sites should develop quality control procedures. It is important to note that the following guidelines are the standard for most inspections; However, for some trials, different specific requests may be warranted. Therefore, data should not be provided until contact with the rapporteur has been established and the data list requirements have been reviewed. Systematic gaps in documentation can lead to questions about data integrity, which can lead to decisions by the health authority to exclude data from the analysis. The marking of the containers should be in accordance with local rules. Various health care records for patients who have been the subject of clinical studies (whether healthy subjects or subjects) are established and maintained.

Some of them are general in nature and refer to the general health care of the subject before, during and after the study. Others are process specific. A clinical trial as a scientific enterprise requires careful recording to ensure that data is collected and reported correctly and completely.