Contents
1 Aim
This SOP will outline the procedure for a unified approach to version control of all documents that are submitted to the research office. Those created by the research office should be done so following the guidelines set out in in the RDASH policy and procedural documents (development and management) policy.
2 Scope
All staff, internal or external, to the trust who take on the role of document creation and, or updates and any member of the research team with delegated duties to maintain master or site files.
3 Link to overarching policy
4 Procedure
All documents submitted must be designated a unique numerical version and date of creation. This is a standard procedure to ensure:
- all users of a document use the most up to date version in order to ensure that accurate procedures are being followed at all times
- that an audit trail of version-controlled documents is made available once a document is approved for use and subsequently reviewed and, or changed
- a consistent format should be used on all documents created for use in a research study. The document short title, version and date should be added to the document footer. The file name should be the same as the footer. For example, document title, V1.0, 20220101
5 Prior to regulatory approval (draft)
- The author of the document numbers the original version ‘draft v (version) 1.0’ and the date of creation, ‘20220101’.
- The author re-numbers the version when making administrative changes (grammar, spelling, syntax) to the document, using a decimal place, ‘draft v1.1’, ‘draft v1.2’ and so on, and dates the documents.
- The author re-numbers the version when making substantial changes (changes in content, procedure or additions of information) to the document and also dates the documents.
- The version number increases incrementally with each new substantial change, ‘draft v2.0’, ‘draft v3.0’.
- The numbering continues with the administrative changes rule with each version- ‘draft v2.1’, ‘draft v2.2’ and so on.
- The author files the previous electronic version of the document in the designated archive section of their departmental network drive.
- The relevant qualified person reviews and approves the draft document.
- The author files the latest electronic draft version in the designated archive section of their departmental network drive and deletes all previous draft versions.
- When the document is ready to submit for regulatory approval ‘draft’ should be removed from the file name and the version is reset as v1.0.
6 After regulatory approval
- Refer to national guidance on amendments to approved study documents to ensure regulatory approvals are maintained. Guidance is available on the integrated research application system (IRAS) website.
- The author re-numbers the version when making administrative changes (grammar, spelling, syntax) to the document, using a decimal place, ‘v1.1’, ‘v1.2’ and so on, dates the documents.
- The author re-numbers the version when making substantial changes (changes in content, procedure, or additions of information) to the document and dates the document.
- The version number increases incrementally with each new substantial change, ‘v2.0’, ‘v3.0’.
- The numbering continues with the administrative changes rule with each version, ‘v2.1’, ‘v2.2’ and so on.
- The author files the previous electronic version of the document in the designated archive section of the study folder their departmental network drive.
- The relevant qualified people review and agrees the document, usually the chief investigator and sponsor contact.
- The author files the latest electronic draft version in the designated archive section of their departmental network drive and keeps all previous approved versions.
- The amended document(s) are submitted for regulatory approval.
- Once the document(s) are approved the ‘amendment log’ is updated (see appendix A). This allows the document history to be audited easily.
Footnote, individuals should save their work on the trust network rather than on their computer hard drive. For those working in the Grounded Research team, save to the study folder:
- L:\Corporate\Research Team\STUDIES\Study Folder
7 Appendices
7.1 Appendix A Amendment log
Document control
- Version: 2.1.
- Unique reference number: 430.
- Date ratified: 29 January 2024.
- Ratified by: Clinical policy approvals group.
- Name of originator: Research governance manager.
- Name of responsible individual: Research panel.
- Date issued: 9 February 2024.
- Review date: January 2025.
- Target audience: All staff involved in research.
Page last reviewed: April 15, 2024
Next review due: April 15, 2025