In a perfect world, all the data needed to complete a clinical trial case report form would be found in the medical record. Unfortunately, we do not live in a perfect world!
In many clinical trials, specific measurements and observations, which are not considered “standard of care” and not be part of the routine assessment, are necessary for the trial. It is in these instances that a worksheet may be utilized as the source documentation. Recently, I have been questioned if this was adequate source documentation.
What is the definition of source documentation? From ICH GCP, a source document is “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).
Or, a common statement to describe source is the first place an assessment or observation is recorded. If we utilize that definition, then a worksheet can be used as source documentation. Do all worksheets for a study have to be used? Do all data points on the worksheet have to be completed? My response to these questions is no. Duplicating what is entered into a subject medical record on a worksheet, increases the work and the risk of transcription error. A monitor can verify a clinic visit, recorded in the medical record that correlates to the date and time of the worksheet.
A review of recent FDA warning letters to investigators reveals a recurring theme:
“You have failed to maintain adequate and accurate case histories by failing to ensure that XXXXXX Worksheets accurately listed the person who conducted exams as documented in subjects’ medical charts……Your failure to maintain adequate and accurate case histories, including the failure to ensure that the names and signatures of study personnel were accurately recorded on the XXXXXX Worksheets, raises concerns about the validity, reliability, and integrity of data captured at your site.”
As a monitor, I look for clear documentation on the worksheet of who performed the assessment and when it occurred (signatures and dates on worksheets can take care of that – see our ALCOA checklist). I verify that they are qualified by training and the study to complete the assessment. These worksheets must become part of the subject binder and are subject to the same retention requirements the other study documents are. Using the worksheet and a clinic note for source documentation accomplishes two key items: 1) it satisfies the protocol testing requirements and 2) having a clinic note may demonstrate the patient received the routine standard care in addition to the research assessment.
What do you think the FDA’s Auditors view of worksheets as source documentation is? What guidelines do you follow when using worksheets?
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