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If available, study sites may use their own established PSF format if agreed with the Trial Manager/Sponsor.  \n3.0 RESPONSIBILITIES  \n3.1 If sites do not have their own established PSF format, the Trial Manager or designee will be responsible for creating the PSF for each site.  \n3.2 If the PSF is provided by the Trial manager or designee, the Pharmacist or designee at site will be responsible for confirming receipt of the PSF.  \n3.3 The Pharmacist or designee at site will be responsible for maintaining the PSF and ensuring that it is held in a secure location for the duration of the study.  \n3.4 Trial Manager or designee will be responsible for ensuring that any updated documents applicable to the PSF are provided to the site as required. The receipt of these should be logged appropriately.  \n3.5 The Principal Investigator (PI) at site will be responsible for ensuring that the PSF is archived along with the Investigator Site File (ISF) in accordance with the protocol.  \n3.6 The Pharmacist or designee will ensure that the PSF is complete and has been reviewed prior to archiving.  \n4.0 PROCEDURE  \n4.1 Creating a Pharmacy Site File (PSF)  \n4.1.1 The PSF will be created by the Pharmacist, or designee, prior to the start of the study at their site using their own established PSF format. Alternatively, if the site don’t have a PSF format, the Trial manager or designee will be required to create the PSF for the site using the PSF Contents template below (see 4 .1.6) .  \n4.1.2 The PSF will be split into six main sections. Additional sections and sub-sections can be added as required and the PSF Contents page updated accordingly.  \n4.1.3 Where applicable, each section will contain a sub-section for superseded documents.  \nThe user of this document is responsible for ensuring it is the current version.  \nECTU Central Office SOP Template v3 .0 Page 2 of 4  \nECTU SOP Identifier Version No Effective Date  \nECTU_TM_ 18 3.0  \n22 Jul 2024  \n4.1.4 The PSF Contents Page will be the first page of the PSF and all documents will th","cbCaifBSUMEWt7uG","https://ap.wps.com/l/cbCaifBSUMEWt7uG","pdf",289234,6,"English","# 1. Purpose\n# 2. Scope\n# 3. Responsibilities\n## 3.1 Trial Manager / designee\n## 3.2 Pharmacist / designee\n## 3.3 Principal Investigator\n# 4. Procedure\n## 4.1 Creating a Pharmacy Site File (PSF)","[{\"question\":\"What is the purpose of this SOP?\",\"answer\":\"It describes the procedure for creating and maintaining a Pharmacy Site File (PSF) for a CTIMP study.\"},{\"question\":\"Which studies does this SOP apply to?\",\"answer\":\"It applies to all CTIMP studies fully managed by ECTU where a PSF will be required and is not already available at the site.\"},{\"question\":\"Who is responsible for creating and maintaining the PSF?\",\"answer\":\"If sites lack an established PSF format, the Trial Manager or designee creates the PSF for each site. The Pharmacist or designee at site confirms receipt (if provided) and maintains the PSF in secure storage, ensuring it is complete and reviewed prior to archiving.\"}]","ECTU Central Office SOP Template v3.0 - TM 18 - Creating and Maintaining a Pharmacy Site File (PSF) | PDF",1790076940]