Good clinical practice data recording

The verification of compliance with the standards of good clinical practice and the need to subject data, information and documents to inspection in order to confirm that they have been properly generated, recorded and reported are essential in order to justify the involvement of human subjects in clinical trials. 

Quality Assurance (QA). All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). 

The fundamentals of good data recording practices should be observed in clinical supply manufacturing in exactly the same manner as required for commercial materials. Those fundamentals include the following ... 

Studies can be done solely using information on a database, particularly if the quality of the data has been validated. However, it is often considered good practice to seek additional information from clinical records particularly to confirm that there is adequate evidence to support the diagnosis in individual cases. This may lead to some potential cases being excluded and exclusions may be specified for other reasons but, in general, these should be kept to a minimum in order to retain the advantage that such data have in representing real life. 

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