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V1 Fast

By Joseph Saponaro posted 05-01-2012 06:11 AM

  
DSI had this come up at a Sponsor induced audit for a pain mgt. Drug Study trial where they asked me if it were not a violation of GCP to have subjects fast for V1 prior to their signing the ICF.  My response was consent is a process; the most proximal is the ad, then the V1, etc....  I explained our process of how to minimize harm and maximize benefit.  I enquired if she had knowledge of how to do it better, and she did not.  I called the Sponsor to enquire about her and they told me to ignore thi8s silly question.

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCTI, CCRC, CCRP
www.DrugStudy.MD   
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Comments

Kristina Cleveland
07-31-2012 11:31 AM

This has come up several times in our practice. I was taught that we can not ask a subject to fast for a visit prior to signing a consent. We can however let them know what would be required at the visit, if they sign consent. In several protocols, this is asked for at screening. We tend to consent and screening the subject on the same day. I talked with the sponsor. Then the sponsor said that we could do the blood work on the next day if they were not fasting.
I hope this helps.
Kristina Cleveland, CCRC