A variety of records is generated and maintained relating to the healthcare of clinical trial subjects
(whether study subjects or healthy subjects). Some of these are general and relate to the general
healthcare of the study subject before, during and after the trial. Others are specific to the trial. A
clinical trial as a scientific undertaking requires careful record-keeping to ensure that data are collected
and reported in an accurate and complete manner. In addition regulations and guidelines have
established processes including investigator review, monitoring, auditing and inspection, in order to check
and control the accuracy and completeness of the data. GCP, ethical requirements and medical standards
require that each study subject is cared for and this duty to the individual is put above the more general
scientific needs.
There are national, professional, local, or institutional requirements either in law, various forms of
guidance, rules, or established practice which define many requirements for the maintenance of records
in the course of normal study subject care. Any requirements that may arise as a consequence of the
conduct of clinical trials can only be an addition and not a substitute for these, since the conduct of a
clinical trial should never diminish the standard of care.
Many of those involved in clinical research ask questions about what should be documented, when,
where, by whom and for what reason.
The purpose of this document is to set out some of the main elements of this study subject recordkeeping
in the clinical trial context, in order to assist those involved in clinical research to understand why
such records are kept and looked for, and in order to help in planning record-keeping in specific contexts.
Taking into account the various issues outlined it is very unlikely that a CRF would ever suffice as the
complete and only record of a study subject relevant to their participation in a clinical trial.
