ECTU Central Office SOP Template v3.0 - TM 18 - Creating and Maintaining a Pharmacy Site File (PSF)

Sep 22, 2026

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Standard Operating Procedure describing how to create and maintain a Pharmacy Site File (PSF) for CTIMP studies managed by ECTU where a PSF is required and not already available at site. Defines responsibilities for Trial Manager, Pharmacist/designee, and Principal Investigator, and sets out procedures for PSF creation, section structure, document filing rules, labeling, secure storage, updates and receipt logging, and PSF completeness review prior to archiving.

LanguageEnglish

CategoryForms

FormatPDF

Pages6

Reading Time2 min

AccessFree to download

1. Purpose

2. Scope

3. Responsibilities

3.1 Trial Manager / designee

3.2 Pharmacist / designee

3.3 Principal Investigator

4. Procedure

4.1 Creating a Pharmacy Site File (PSF)

ECTU SOP Identifier Version No Effective Date ECTU_TM_ 18 3.0 22 Jul 2024 ECTU Central Office SOP _TM_ 18: Creating and Maintaining a Pharmacy site File (PSF) | Version No: | 3.0 | | --- | --- | | Issue Date: | 04 Jul 2024 | | Effective Date: | 22 Jul 2024 | | Authorship and Approval | | | | | | | --- | --- | --- | --- | --- | --- | | Name and Designation | Author/Reviewer/ Approval/ Authorisation | Date | Signature | | | | Anna Heye, Trial Manager | Author | 04-Jul-2024 | |
Anna Heye (Jul 4, 2024 11:58 GMT+1) | | | Gayle Beveridge, Trial Manager | Reviewer | 04-Jul-2024 | | | | | Gina Cranswick, Trial Management Team Lead | Approver | 04-Jul-2024 | | Gina Cranswick
Gina Cranswick (Jul 4, 2024 15:55 GMT+1) | | | Tanya Tharakan, QA Manager | QA Authorisation | 04-Jul-2024 | | | | | | | | | Tanya Tharakan (Jul 4, 2024 16:25 GMT+1) | | | Document Revision History | | | | --- | --- | --- | | Version No. | Effective Date | Summary of Revisions | | 1.0 | 20 Sept 2019 | Initial creation | | 2.0 | 11 Jul 2022 | Moved to new SOP template
Section 4.1.1 updated and section 4.2.5 added | | 3.0 | 22 Jul 2024 | Addition of Pharmacy Site File receipt process (sections 3.2 and 4 .1.8)
Addition of section 4.1.10
TM-T11 ECTU Pharmacy Manual Template incorporated Minor formatting changes and clarifications throughout | The user of this document is responsible for ensuring it is the current version. ECTU Central Office SOP Template v3 .0 Page 1 of 4 ECTU SOP Identifier Version No Effective Date ECTU_TM_ 18 3.0 22 Jul 2024 1.0 PURPOSE This Standard Operating Procedure (SOP) describes the procedure for creating and maintaining a Pharmacy Site File (PSF) for a Clinical Trials of Investigational Medicinal Products (CTIMP) study. 2.0 SCOPE This SOP applies to all CTIMP studies that are fully managed by ECTU where a PSF will be required and is not already available at site. If available, study sites may use their own established PSF format if agreed with the Trial Manager/Sponsor. 3.0 RESPONSIBILITIES 3.1 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. 3.2 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. 3.3 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. 3.4 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. 3.5 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. 3.6 The Pharmacist or designee will ensure that the PSF is complete and has been reviewed prior to archiving. 4.0 PROCEDURE 4.1 Creating a Pharmacy Site File (PSF) 4.1.1 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) . 4.1.2 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. 4.1.3 Where applicable, each section will contain a sub-section for superseded documents. The user of this document is responsible for ensuring it is the current version. ECTU Central Office SOP Template v3 .0 Page 2 of 4 ECTU SOP Identifier Version No Effective Date ECTU_TM_ 18 3.0 22 Jul 2024 4.1.4 The PSF Contents Page will be the first page of the PSF and all documents will th

FAQs

What is the purpose of this SOP?

It describes the procedure for creating and maintaining a Pharmacy Site File (PSF) for a CTIMP study.

Which studies does this SOP apply to?

It applies to all CTIMP studies fully managed by ECTU where a PSF will be required and is not already available at the site.

Who is responsible for creating and maintaining the PSF?

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.

Sep 22, 2026

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