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patient stipend

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Guest
#1 · July 21, 2022, 6:52 pm
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Does anyone document in the source that the stipend was given to the patient?

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brad@brad
184 Posts
#2 · July 21, 2022, 7:12 pm
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Quote from Guest on July 21, 2022, 6:52 pm

Does anyone document in the source that the stipend was given to the patient?

It's recorded in our CTMS but probably not a bad idea to put it in a progress note if you don't have record in a CTMS.

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Jeanette@site-line
25 Posts
#3 · July 22, 2022, 4:04 am
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Our site has the payment history show in the CTMS, which is linked to the subject eSource. If there is ever an issue that arises with the payment vendor that causes a delay in payment being issued to a subject, we will document this as a progress note at the time.
If you don't use a system that automatically links payments to the subjects source,  I would definitely recommend documenting payment history in the subject record, whether in a progress note or other form of documentation.
When our site underwent a routine FDA inspection in 2019, for a study that was conducted prior to integrating our CTMS, the FDA inspector checked the stipend amount & the payment schedule listed  on the ICF, and then verified subjects were compensated as agreed upon.  

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Guest
#4 · July 25, 2022, 2:27 pm
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Thanks for your input.  We have been through 5 fda audits and they have not asked.  

Thanks

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