Pharmacy Establishment Plans Sample Clauses

Pharmacy Establishment Plans. A Pharmacy Establishment Plan is required for each site conducting an HPTN study involving study product(s). A copy of the DAIDS Standard Pharmacy Establishment Plan form can be found in the Pharmacy Guidelines and Instructions for DAIDS Clinical Trials Networks. An electronic copy is made available to the site via DAIDS PAB. The Pharmacy Establishment Plan (PEP) and applicable PEP Module(s) must be approved by the DAIDS PAB as a condition for shipping study product to a site and for initiation of study procedures. This plan is submitted directly by the site Pharmacist of Record to the DAIDS PAB for review and approval. The Pharmacist of Record is encouraged to work with study investigators and other local staff members to complete the DAIDS Pharmacy Establishment Plan. Questions regarding the completion and review of Pharmacy Establishment Plans should be directed to the DAIDS PAB. (For studies where product may be managed by the HPTN Pharmacist, see Section 23.)
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Pharmacy Establishment Plans. A Pharmacy Establishment Plan is required for each site conducting an HPTN study involving investigational product(s). A copy of the DAIDS Standard Pharmacy Establishment Plan form can be found in the Pharmacy Guidelines and Instructions for DAIDS Clinical Trials Networks. An electronic copy is made available to the site via DAIDS PAB. The Pharmacy Establishment Plan must be approved by the DAIDS PAB as a condition for shipping study product to a site and for initiation of study procedures. This plan is submitted directly by the site Pharmacist of Record to the DAIDS PAB for review and approval. The DAIDS PAB will provide an initial response to the Pharmacist of Record within 10 to 12 working days; revisions and review will continue until PAB has approved the Plan. The Pharmacist of Record is encouraged to work with study investigators and other local staff members to complete the DAIDS Standard Pharmacy Establishment Plan. For sites conducting multiple studies using different types of products with different storage and dispensing requirements (e.g., topical microbicides and systemic antiretrovirals), DAIDS PAB may require that a separate Pharmacy Establishment Plan be completed for each study. Questions regarding the completion and review of Pharmacy Establishment Plans should be directed to the DAIDS PAB.
Pharmacy Establishment Plans. A Pharmacy Establishment Plan is required for each site conducting an HPTN study involving study product(s). A copy of the DAIDS Standard Pharmacy Establishment Plan form can be found in the Pharmacy Guidelines and

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