Controlled Access Program (CAP) linkage to PSP enrolment form
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Hello PAAB,
The team that we work with is creating a Controlled Access Program (CAP) website as a part of a Risk Management Program. The team intends to submit the CAP website for a PAAB opinion as a RMT. They want to link to a digital PSP enrolment form from the CAP website.
Our question: Will PAAB require that they review the PSP enrolment form as a part of the CAP opinion? Does the PSP enrolment form they are linking out to have to have an eFile # for the purpose of the opinion on the CAP website?
Thank you!
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Per Health Canada guidance, PSPs are not a type of additional Risk Minimization Measure/Tool, therefore, there should be no mention of the PSP within the RMT. Participation in the PSP should not be seen as a part of conditions for receiving the drug. Given this, the enrollment form question would be moot. Please, let us know if any new questions come up given the response.
