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QRTI Newsline --- Wednesday September 8, 2010

What's Wrong with Source Document Worksheets?

By Phyllis B. Kent

From the very basic training given in Clinical Research, we are instilled with the need for source documents to support the data entered onto a Case Report Form (CRF). To help clinical sites meet this requirement, sponsors and CROs develop detailed Source Document "tools" and "worksheets", that are typically identical to the Case Report Forms with modified headings.

• What better way to ensure that every piece of data captured has a source?

Unfortunately, these "Source Document Worksheets" frequently increase site efforts, increase monitoring time and decrease patient safety, without any increase in the quality of the data collected for the study.

• How do the worksheets increase time?

Using worksheets requires that the study staff transcribe all data onto the CRF. In addition to the time consuming effort of rewriting the same information, this task creates the potential of transcription errors.

• So what is the value of writing it on a worksheet instead of the CRF?

The popular argument that the value of worksheets is that they facilitate the capture of all required study data. However, the CRF can serve the same purpose. Using worksheets only adds more work for the site and creates the opportunity to make transcription errors. This also increases the monitoring time because the monitor must also check for transcription errors, in addition to verifying the data in the CRFs against the source document.

• What about source documentation?

Source documentation, as we are trained early on is the first place the information is recorded. The CRF can be the source for study data, if it is the first place the data is recorded. The patient's chart should be the source document for the routine medical information captured on a patient visit. The CRF can be used to capture additional study specific data. If study specific data is to be recorded directly on a CRF, this should be documented in the patient's chart and in a memo in the regulatory binder.

• What will the FDA inspector say when they find the CRF is the source?

FDA is concerned with the accurate recording of data and patient safety. FDA looks for a source medical chart containing the medical history, diagnosis, tests, treatments and medications. The medical/clinical chart should document the history of the disease currently being studied. Each visit should be recorded in the medical/clinical chart with the patient's current disease status, medications, and any adverse reactions noted.

• What about the physician's role?

The physician's assessment of the patient and the results of any tests should be included. This is the routine medical record kept for patient visits and is good clinical practice. FDA does not require every datapoint on the CRF to have a source document. As long as a medical chart is kept with the appropriate visit documentation, the CRF can be the source for study data.

• So what's wrong with "Source Document Worksheets"?

Many sites are using source document worksheets to replace the medical chart. Few, if any, sites retain the worksheets as a permanent part of the subject's chart. Although the data is captured on the worksheet, the data is not available for review after the study is completed., The patient's chart then has holes where data is missing from their medical history. In doing this, the sites are not following good clinical practice or caring for their patients' safety and welfare. Also, the medical course of the patient is often not adequately followed when the focus is to capture what is needed for the study rather than for the patient's medical welfare.

• Are we losing track of important data?

Study data, i.e., worksheets and CRFs, are archived when a study is complete and it is unlikely that they will be accessed again, unlikely to ever be seen again. Patient care is compromised because the physician has only a partial medical record to review and cannot easily access past treatments and adverse experiences. Without a complete medical history, overlapping treatments or retreatment with a problematic medication may compromise the patient.

• How does this impact the studies?

Without a single complete medical history, sites may be enrolling subjects who would be excluded based upon prior treatments, conditions, or adverse reactions. Studies could be overlapping as study worksheets, specific to one particular study, are stored with the study files and cannot be reviewed by a monitor for another study.

• Where is the FDA's place in all of this?

The FDA will be able to access all studies and will likely cite incomplete medical history on subsequent studies or worse yet patient neglect because of inappropriate inclusion in a study. Both the investigator and the sponsor may be found negligent and the study data inadequate and/or unusable.

• What should sites do when a monitor encourages the use of worksheets?

The investigator sites should maintain complete medical charts for each subject. If worksheets will not be placed into the medical chart, then the investigator should decline their use. The site should focus on a comprehensive chart note for each visit including a note that the study specific data will be recorded directly on the CRF.