Such as: Diaries of coordinator, inpatient records of the hospital, electronic records, etc., for the simple reason that the staff does not realize that these form a part of source record.
In India, the documentation in routine medical practice may not be as extensive as what would be expected for clinical research.Īdditional unmonitored medical records are discovered at the time of audits/inspections. As a result the principal investigator (PI) and staff may continue documentation per the routine medical practice. Inadequacies in documentation could be the result of lack of training and experience in good understanding of clinical research and documentation requirements. Moreover clinical research happens over a long period of time which adds to the challenge of maintaining continuity in the documentation practice. Thus rendering this process to be complicated and posing challenges to meet requirements. WHAT ARE THE POSSIBLE ROOT CAUSES FOR REPEATED DEFICIENCIES IN SOURCE DOCUMENTATION?Ĭlinical research documentation involves a variety of documents from various sources and is often completed by several people. Let‘s look at these attributes described by different authorities collectively.
EMA has added some more ‘letters’ to describe qualities of good source documentation particularly for electronic documentation. These are also adapted by World Health Organization (WHO). Key attributes for good documentation were first described by US-FDA in the form of ALCOA -attributable, legible, contemporaneous, original and accurate. This definition describes the various types of documents which collectively form the source document.
#Define redacted medically verification
Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, X-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). There can not be two thoughts to emphasize the need for reliable and quality documentation. Irrespective of clinical trial, accurate documentation supports the fundamental principle of protecting subject’s rights, safety and well-being. It serves as the complete medical record of the subject as the reference to the treating physician at any point of time.įinally it forms a strong foundation for the data that gets transcribed into a CRF which ultimately gets translated into a clinical study report. It records the accountability of the investigational product dispensed, consumed and returned by the subject. It documents the progress of the subject from consenting till the subject completes the study. It is the tool which confirms the eligibility criteria of the subject in the given trial. Source documentation is the medical record of the subject before, during and after the trial.
Documentation should be such that it is able to provide audit trail to permit investigation if and when required. It should enable an independent observer to reconfirm the data.
#Define redacted medically trial
The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. To understand the importance of good source documentation we should first review the purpose of source documentation. WHAT IS THE PURPOSE OF SOURCE DOCUMENTATION? There were two underlying potential issues here: For the trial subjects there were no other hand-written progress notes which the site would normally use for routine patients. This method was adopted only for clinical trial subjects. In normal practice the site did not use MS word to generate medical records. The site was actually using MS word to document the data collected during the study. I would like to share an experience at a recent investigator site audit.ĭuring the audit opening meeting we were informed that all the source data is on paper and no electronic documentation is used. Not surprisingly, clinical trial monitors and auditors also report documentation issues as a frequent area of GCP concern. Similarly, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of investigator sites in 2009 and in some instances the findings were classified ‘critical’. Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites.
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