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The procedure defines responsibilities across the Data Management team, specifies required header and footer elements for Word and Excel templates, and sets naming conventions for Draft, Pilot, and Final statuses. It also requires a Template Revision History and provides guidance text rules. 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May 2024 |\n\n\n| Authorship and Approval |  |  |  |\n| --- | --- | --- | --- |\n| Name and Designation | Author/Reviewer /Approval/ Authorisation | Date | Signature |\n| Lynsey Milne Data Manager | Author | 23 Jan 2024 | See retained email approval dated 23 Jan 2024 |\n| Ruth Armstrong\u003Cbr>Assistant Data Manager | Reviewer | 05 Feb 2024 | See retained email approval dated 05 Feb 2024 |\n| Tony Wackett, Data Management and Programming Architect | Reviewer | 22 Jan 2024 | See retained email approval dated 22 Jan 2024 |\n| Kenton D’Mellow\u003Cbr>Data Management and Programming Team Lead | Approver | 11 Apr 2024 | See retained email approval dated 11 Apr 2024 |\n| Tanya Tharakan QA Manager | QA\u003Cbr>Authorisation | 22 Jan 2024 | See retained email approval dated 22 Jan 2024 |\n\n\n| Document Revision History |  |  |\n| --- | --- | --- |\n| Version No. | Effective Date | Summary of Revisions |\n| 1.0 | 21 Aug 2020 | • Initial creation |\n| 2.0 | 06 May 2024 | • Updated to new SOP template\u003Cbr>• Wording changes to section 2\u003Cbr>• Section 3 added\u003Cbr>• Template control instructions for excel templates added throughout and in Appendix 1\u003Cbr>• Pilot template instructions added to section 4.1\u003Cbr>• Standard review period added to section 4.3\u003Cbr>• Wording and numbering changes made throughout document |\n\n1.0 PURPOSE  \nThis Standard Operating Procedure (SOP) describes the procedure for ensuring all templates and study-specific documents produced by the Data Management team are developed and versioned consistently, and are reviewed on a regular basis to ensure accuracy and efficacy.  \n2.0 SCOPE  \nThis SOP applies to all members of the ECTU Data Management team where they are responsible for creating and maintaining documents for both template and study-specific purposes.  \n3.0 RESPONSIBILITIES  \nDelegation of data management tasks to the ECTU Data Management team will be established at the start of the study as per ECTU Central Office SOP ECTU_SOP_DM_01 Data Management Procedures.  \nWhere a task is delegated to the team, the Data Manager or Assistant Data Manager allocated to that study is responsible for creating all relevant documents.  \nAll members of the ECTU Data Management team are responsible for establishing, reviewing and maintaining document templates.  \n4.0 PROCEDURE  \n4.1 Creating a new Data Management Template  \n4.1.1 Each template developed and implemented by the Data Management team will be assigned a template identifier. The template identifier is unique to each template, starting with DM001 . This identifier will remain the same on all versions of the template. Template identifiers are assigned on an ascending basis with each new template developed (e.g. , DM001, DM002, DM003) .  \n4.1.2 All templates are subject to version control and will be set at version 1.0 at initial creation. Once set, the version number will remain the same on all draft, pilot and final versions of the template. Version numbers will only change when the template is revised and a new version is created. New version numbers will be set by increasing by one whole number each time (e.g. , v1 .0, v2 .0) .  \n4.1.3 When a new template is created, the following must be included in the header in a word document or in appropriate cells in the first worksheet on excel spreadsheets:  \n• ECTU Logo  \n• Study Name/Acronym Field*  \n• Study Specific Document Name Field*  \n• Version Number Field*  \n• Document Version Date Field*  \n* For completion with study-specific information when the template is adapted for use in a study  \n4.1.4 In the footer in a word document or in an appropriate locked cell (see Appendix 1) in the first worksheet on excel spreadsheets, the template name should be included in the following naming conventions , depending on the status of the template. These naming conventions should also be used to ","cbCaisbOLxYwOISv","https://ap.wps.com/l/cbCaisbOLxYwOISv","pdf",230808,7,"English","# 1.0 Purpose\n# 2.0 Scope\n# 3.0 Responsibilities\n# 4.0 Procedure\n## 4.1 Creating a new Data Management Template\n## 4.2 Template Status – Draft, Pilot and Final Status\n## 4.3 Template Review Period\n## Appendix 1 - Template Control Instructions (Excel)","[{\"question\":\"What is the purpose of SOP_DM 07?\",\"answer\":\"SOP_DM 07 ensures all Data Management templates and study-specific documents are developed and versioned consistently and reviewed regularly to maintain accuracy and effectiveness.\"},{\"question\":\"Who is responsible for creating and maintaining documents under this SOP?\",\"answer\":\"When tasks are delegated to the Data Management team, the allocated Data Manager or Assistant Data Manager creates the relevant documents, while all team members establish, review, and maintain the templates.\"},{\"question\":\"How are template versions and identifiers managed?\",\"answer\":\"Each template is assigned a unique identifier (e.g., DM001, DM002) that remains the same across versions, while version numbers remain at 1.0 initially and only change when a template is revised, increasing by one whole number (e.g., v1.0 to v2.0).\"}]","ECTU Central Office SOP_DM 07 - Data Management Document Version Control and Review - Version 2.0 | PDF",1789194931]