One of the fundamental principles of Clinical Research is: “if it is not documented, it is not done”. The attributes of source documentation, we, as research personnel, should be looking for are ALCOA: Attributable, Legible, Contemporaneous, Original and Accurate. (The IMARC ALCOA Checklist is a helpful tool for understanding the importance of these qualities.)
In respect to clinical research, the monitors look to the subject’s medical record to verify the data being submitted on Case Report Forms (CRFs). In the past, the motto of “if its not documented it was not done” was the standard. Frequent documentation of a subject’s status was contained in a narrative progress note or flow sheets with frequent (hourly) notations. As medical facilities transition to electronic medical records, documentation by exception is becoming increasingly common. The definition of documentation by exception is a notation is made only when there is a deviation from baseline or an unexpected outcome. Therefore, a check mark on a flow sheet indicates that all standards and protocols were followed during the time period.
So how does the monitor verify the “standard of care” items that are checked off once per shift? For the sake of example, consider an orthopedic study that requires the use of Deep Vein Thrombosis (DVT) prevention. This is considered standard of care and its use is denoted by a checkmark on a recovery room admission check list. The rational given is that because this is considered “standard of care” and an expected activity, no further documentation is needed. The monitor can verify the physicians order and observe the check mark for following the DVT prevention protocol on the flow sheet. But, is this sufficient to document the protocol requirement of DVT prevention protocol? What can the monitors do to verify the data? Is it sufficient to review the protocol requirements for DVT prevention protocol and compare to these to the hospital’s standard of care? Is any additional documentation warranted?
Here is another example: If the oxygen was noted to be at 2 L per minute per nasal cannula 6 hours ago and no new notation was made, can you verify that the subject was continuing to receive the oxygen as per the standard of care? Does that satisfy sufficient source?
Have you been noticing more charting by exception? How do you ensure all protocol requirements are followed with the trend toward minimal documentation?
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