Version Control of Study Specific Documents

Transcription

1 SOP Title Version Control of Study Specific Documents SOP No. SOP 10 Author Consulted Departments Lead Manager Sign and Print Name Julia Farmery Revision V2.0: Sarah Fahy Lincolnshire Clinical Research Facility, Research and Development, Trust consultants and research staff. Professor Tanweer Ahmed Director of LCRF, Head of Research and Development and IP Lead Date published 12/07/2017 Review date of SOP 12/07/2019 Version 2.0 Version 1 superseded 12/07/17 Page 1 of 6

2 Version History Log This table should detail the version history for this document. It should detail the key changes when a version is amended. Version Date Implemented Details of key changes /08/2010 Not applicable /07/2017 This document has been significantly re-written and it is recommended that all staff to whom this SOP is applicable familiarise themselves the content of this Version 2.0 SOP Title: updated Applies to: updated Relevant SOPs: updated Definitions: updated Policy: updated Procedure: updated Responsibilities: updated 1. Purpose: This SOP has been produced in accordance with the Research Governance Framework 2005 and ICH GCP. This SOP will outline the procedure for a unified approach to version control for all controlled documents that are created, used by or submitted to the Research and Development department. It is essential that all users of a controlled document use the most up to date version in order to ensure that accurate procedures are being followed at all times. It is essential that an audit trail of version controlled documents is made Page 2 of 6

3 available once a document is approved for use and subsequently reviewed and/or changed. Version Control is the management of multiple revisions to the same document. Version control enable us to tell one version of the document from another. Applies to: Chief Investigators who run studies in ULHT. This SOP applies to all staff who create and edit study specific documents. This would usually be locally sponsored studies only. However the principles of version controlled documents can be applied to other documents used within the Trust. Relevant SOP documentation : Trial Master File SOP Investigator Site File SOP Amendments SOP Definitions : Health Research Authority - HRA Medicines and Healthcare products Regulatory Agency - MHRA Research and Development R&D Research Ethics Committee - REC United Lincolnshire Hospitals NHS Trust ULHT Policy: EU Clinical Trial Directive (2001/20/EC) accessed on 15/03/2012, available at: 034:0044:en:PDF The UK Clinical Trial Regulations No. 1031, No. 2754, No. 2759, No. 1928, No. 2984, No. 941, No Research Governance Framework available at: 2. Procedure: Page 3 of 6

4 2.1 The following study specific documents must be given a version number and date: Protocol Patient information sheet and other information sheets Informed consent form GP or hospital consultant letter Adverts Patient study card Case report forms Substantial and Minor amendments Study prescriptions Study medication labels Trial Master File forms e.g. the Delegation Log Pharmacy documentation (prescriptions, labels, accountability forms etc.) will be version controlled according to the pharmacy SOP. 2.2 The author of the document should originate the version numbers. 2.3 All users of study specific documents must use the most recent version that has been approved by the MHRA and/or HRA, REC and Trust R&D. 2.4 The version number and date should either be in the header or footer of the document so that it appears on every page of the document. 2.5 Date the document with the date that the new version of the document is saved. 2.6 The first draft of the research document should be labelled Draft Version 0.1 and dated. Further draft versions should be labelled Draft Version 0.2, 0.3 etc. and dated i.e. each draft version becomes a decimal place larger. 2.7 The final original version of the research document should be labelled Final Version 1.0 and dated. This version will be submitted for the appropriate approvals or authorisations. 2.8 If substantial amendments are necessary following appropriate approvals or authorisations, then subsequent versions of the research document may be labelled Draft Version 1.1, 1.2 whilst being revised and reviewed and the version re-submitted for approval should be labelled Final Version 2.0 and dated. Page 4 of 6

5 2.9 If the study document is then substantially amended again during the study then the version submitted for approval of the amendment will be labelled Final Version 3.0 and so on If the study document requires only a minor amendment (and therefore only HRA approval) during the study then the version used will increase by a decimal place larger Final Version The relevant qualified individual must review and authorise the amendment. Please see Amendment SOP An electronic and hard copy of all Final study documents and also a tracked changes version should be filed in Trial Master File (Locally Sponsored Studies) and the Final study documents also filed in the Investigator Site Files at all sites actively conducting the study. The tracked changes version can be provided for information purposes to all active study sites The localisation of approved study documents i.e. entering local contact details, adding local Trust logo s does not constitute an amendment, therefore, version numbering and dating should not be altered. 3. Responsibilities 3.1 It is the responsibility of the Chief Investigator and the Principal Investigator to ensure all documents have appropriate version control. 3.2 It is the responsibility of the Chief Investigator and the Principal Investigator to ensure versions have appropriate regulatory approval and have R&D approval before use. 3.3 Circulation of study specific documents to research sites. When a new version of a document is issued to sites, the researcher should obtain written confirmation from the principal investigator at each site that: the updated document has been placed in the site file the previous version of the document is retained in the site file but is marked as SUPERCEDED on the front page all staff working on the study are aware of the changes to the document all stocks of previous versions of paperwork held at site have been destroyed (if applicable) Page 5 of 6

6 References: Thanks are given to Maria Koufali, Assistant Director of Research & Innovation for the adoption of some parts of Nottingham University Hospitals, Training Record, SOP 19. Adopted Information: NHS Lothian and The University of Edinburgh, ACCORD, SOP 015. Version 2. This SOP will be reviewed every two years, a more updated revision of the SOP will be implemented if new local, national or international regulations change. This would therefore replace the existing document. All SOPs can be located on the Research and Development s shared file and a hard copy of all SOPs are kept in the SOP Trial Master File Page 6 of 6