STANDARD OPERATING PROCEDURE

Transcription

1 STANDARD OPERATING PROCEDURE Title Reference Number Document Version Control SOP-QMS-002 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s) Reviewer(s) Teresa O Leary, Head of Regulatory Compliance (Interim) Melanie Boulter, QA Auditor Authorisation (Original signatures are retained by Research & Innovation) Dr Brian Thomson Director of Research & Innovation Dr Stephen Fowlie Medical Director 24 th Nov th Dec 2015 USERS OF THIS STANDARD OPERATING PROCEDURE MUST REFER TO TO ENSURE THE MOST CURRENT VERSION IS BEING USED

2 Page 2 of Document History Version Number Issue Date Reason for Change 1 16 th December 2013 Original SOP. It replaces SOP th Dec 2015 Biennial review

3 Page 3 of Introduction Research documents may be regularly updated; therefore appropriate use of version control must be applied to ensure that the most current approved document is used. Through allocating each revision a unique version number and date, and controlling the distribution of each revision, multiple revisions may be efficiently managed 3. Purpose and Scope This standard operating procedure (SOP) outlines the version control process which applies to NUH R&I sponsored studies and the essential documentation retained within the Investigator Site File (ISF) and the Trial Master File (TMF). This SOP applies to all Nottingham University Hospitals NHS Trust (NUH) personnel and researchers involved in clinical research and who are involved in revising draft and final research documents at their writing, review and approval stage or personnel who control document distribution. 4. Responsibilities All NUH employees and researchers are responsible for ensuring they are using the most current approved document version. NUH personnel and researchers that create or update documents, or control their distribution must adhere to this SOP. NUH R&I Research Project Managers involved in sponsorship management activities for a study must ensure the latest versions of documents are issued to all sites. 5. Definitions CMD CTIMP Documents ISF NUH R&I Clinical Medical Device Clinical Trials of Investigational Medicinal Products Refer to the list in Appendix 1 for examples of research documents Investigator Site File Nottingham University Hospitals NHS Trust Research and Innovation RPM Research Project Manager

4 Page 4 of 11 SOP TMF Standard Operating Procedure Technical Master File 6. Procedure All essential research documents must be identified by: Title Version number Version date Their unique document number (where relevant). This information should be displayed in the document header and/or footer. 6.1 Version Control Process New Document When creating a new document that is likely to go through multiple revisions a consistent numbering system must be used so that version drafts and finals can be easily distinguished. Track changes should be applied in order to highlight changes. The following version numbering should be applied: Initial draft document should be numbered as 0.1 and issued for review. Once changes or updates are applied the draft document should be numbered as 0.2 (and so on) and re-issued for review. Once the final review is complete and all changes are incorporated, the document should be issued for approval at version 1.0 Documents should be approved by CI/PI and Sponsor as a minimum Depending on study type (e.g. CTIMPs or CMDs), REC or MHRA approval may also be required. The document version history should state the approval/issue date. Approved documents must be stored in the ISF or TMF (or both) and electronic copies should be stored in a secured location. Refer to the flowchart in Appendix 2 for guidance on how to apply version numbering.

5 Page 5 of Minor Amendment For minor amendments to documents (e.g. protocol, informed consent form or patient information sheet) the following version numbering should be applied: Once changes or updates are applied the draft document should be numbered as 1.1 Once final review is complete and all changed incorporated, the document should be issued for approval at version 1.1 Documents should be approved by the CI/PI and Sponsor. The document version history should state the approval/issue date. Approved documents must be stored in the ISF and TMF and electronic copies should be stored in a secured location. Track changes should be applied in order to highlight changes. Refer to the flowchart in Appendix 3 for guidance on how to apply version numbering Substantial Amendment For substantial amendments to documents the following version numbering should be applied: Once changes or updates are applied the document should be numbered as 1.1 (and so on) and issued for review. Once the final review is complete and all changes are incorporated, the document should be issued for approval at version 2.0 Documents should be approved by Researcher and Sponsor at a minimum Depending on study type (e.g. CTIMPs or CMDs), REC or MHRA approval may also be required. The document version history should state the approval/issue date. Approved documents must be stored in the ISF or TMF (or both) and electronic copies should be stored in a secured location. Track changes should be applied in order to highlight changes. Refer to the flowchart in Appendix 4 for guidance on how to apply version numbering.

6 Page 6 of Version History The document version history should be summarised so that changes from one version to the next are easily identified. The summary may be contained within the document itself (in SOPs or protocols, for example) or in a separate Document Version Control Log (TAFR00701), or both. The document history and log must be updated each time a new version is created. 6.3 Maintaining Records of Versions During the draft and review process, all electronic documents should be stored in a secure location e.g. restricted network folder. For audit trail purposes all versions should be retained throughout the review process. Often draft versions can be deleted once the final version has been approved; however it can be important to keep draft versions of a document in order to demonstrate decision-making and changes made at each revision of the document. Approved versions must be retained at the very least and issued to the appropriate personnel. Approved versions of documents may be retained electronically or as paper copies, or both; however appropriate controls must be in place to ensure the current approved version is clearly identified and accessed for use. This can be achieved through marking previous versions as superseded or archived in its storage location (network folder or ISF/TMF), or moving previous versions to an alternative storage location (this must be appropriately managed by a nominated individual). For NUH R&I sponsored CTIMP and Medical Devices studies it is essential that the latest approved documents are stored within the ISF and TMF and previous versions are superseded. For amendments the researcher should request the latest approved (electronic) copy from the R&I RPM with track changes applied.

7 Page 7 of Distribution and Training Only final approved versions of documents should be made available to users. Once a new version of a document is finalised it must be distributed so that relevant personnel have access to the current approved version. The appropriate level of control should be applied to the document before it is distributed. For example, to prevent uncontrolled changes to a document it should be considered if pdf or read-only formats need to be distributed, or if documents should be distributed as a controlled copy. Controlled copies should be tracked so that they may be recalled when they are superseded. Once a document is implemented users of the document are required to receive appropriate training and this should be documented. 7. References and Associated Documents TAFR00701 SOP-RES-007 SOP-QMS-007 Document Version Control Log Trial Protocols and Documents Training and Development

8 Page 8 of Appendices Appendix 1. Examples of Research Documents This list provides some examples of research documents that require version control; however this list is not exhaustive. R&I and/or the study sponsor should be consulted to confirm which documents are controlled by whom. Examples: Standard Operating Procedure Protocol or Clinical Investigational Plan Study-Specific Standard Operating Procedure Study Manual Investigator Brochure Case Report Form Information Sheet Consent Form GP Letter Poster Participant Contact Card or Participant Identification Card Prescription Form Deviation Reporting Form Serious Adverse Event Reporting Form

9 Page 9 of 11 Appendix 2. Flowchart for Applying Version Control for New Documents Identify document 0.1* Prepare draft Review draft 0.1_Draft 1_01 0.2_Draft 2_05 0.2_Draft 1_01 Jan 0.3 Draft 3_10 0.3_Draft 2_05 Jan 0.1_Draft 1_01 0.2_Draft 2_05 Approve final version 1_21 *Version numbers should be allocated sequentially and tracked. For example, start with version 1, and when this is superseded the next version should be version 2 and so on.

10 Page 10 of 11 Appendix 3. Flowchart for Applying Version Control to Minor Amendments Identify document 1.0 Prepare draft Review draft 1.1_Draft 1_01 1.2_Draft 2_05 1.2_Draft 1_01 Jan 1.3 Draft 3_10 1.3_Draft 2_05 Jan 1.1_Draft 1_01 1.2_Draft 2_05 Approve final version 1.3_21

11 Page 11 of 11 Appendix 4. Flowchart for Applying Version Control to Substantial Amendments Identify document 1 Prepare draft Review draft 1.1_Draft 1_01 1.2_Draft 2_05 1.2_Draft 1_01 Jan 1.3 Draft 3_10 1.3_Draft 2_05 Jan 1.1_Draft 1_01 1.2_Draft 2_05 Approve final version 2_21