Paper Diaries – Risky Business

 

Many in our industry refer to the “parking lot syndrome” when describing patients rushing to complete days’ worth of their paper diaries for their clinical trial just before their site visit.

Did you know that this “syndrome” was actually captured in a study published by the British Medical Journal (BMJ2002;324:0.6)?

It found that although 90% of subjects reported completing the paper diary on time, only 11% actually completed it as instructed.  They were able to track paper diary entries by embedding photo sensors into the diary binder (to determine when the binder was actually opened).   This compares to a 94% compliance rate with an electronic diary.

The complete article can be read here.

Equally as interesting, the FDA PRO guidance(published in 2009) states the following:

“If a patient diary or some other form of unsupervised data entry is used, we plan to review the clinical trial protocol to determine what steps are taken to ensure that patients make entries according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected.” (pg. 14)

This guidance indicates the regulatory authorities are keenly aware of the non-compliance associated with paper diaries, and intend to monitor patient compliance with diary entries according to protocol requirements.

If your study is designed to collect patient reported outcomes, study endpoints, symptoms, or undesirable events from patients at home, consider using an electronic diary with an automatic date and time stamp, to facilitate regulatory compliance.

You can learn more about assisTek’s Patient eDiaries by clicking here, and see pictures here.

 

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