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Healthy subjects Conmed compliance

By Wilma Villaver posted 10-01-2012 10:07 AM

  

We recently completed an SIV and a question came up from the study monitor.  "How do you question healthy study volunteers to honestly  admit or present to the coordinator that they have recently taken medication prior to or during a study period"?.  Due to study criteria or restrictions, healthy study volunteers are withholding or denying taking medications. Our sites present this questions to the subejcts, in addition also further query them and give them an example.  "Have you recently taken tylenol for headache, musclepain..etc"?  Also,iriterate to them that giving this information will not be the reason for exclusion unless it is in the window of wash-out period prior to taking the study medication.

Any suggestions or helpful comments to improve this process?



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11-12-2012 01:02 PM

Hi Wilma,
As a CRA, I myself like the checklist medical history that is provided to and completed by the patient. It could list several categories such as physical, musculoskeletal, neurological, endocrine, cardio, GYN, etc. Then each category would list several common conditions indications with a Y or N, diabetes, anxiety, LMP, etc. Then a section to list all medications they have taken in the past 60 days. The site staff would then review then answers with the patient to ensure dates, durations, and the aliments were recorded accurately.