STANDARD OPERATING PROCEDURE FOR PREPARATION, REVIEW AND APPROVAL OF SOPS

Transcription

1 Version: Health Research SOP QA01 STANDARD OPERATING PROCEDURE FOR PREPARATION, REVIEW AND APPROVAL OF SOPS Date to be reviewed: See review log Authorship: Health Research SOP Writing Group Approved by: BCUHB R&D Group and Health Research Sub-Committee Responsible director signature: Nefyn Williams Director of R&D, BCUHB J Rycroft Malone Pro-Vice Chancellor for Research, Date approved: Disclaimer: Printed SOPs are considered uncontrolled. To ensure you are working with the current version always refer to the pdf version on the Health Research Quality System website. Health Research SOP QA01 Version Page 1 of 12

2 Bwrdd Iechyd Document History Version Effective Reason for change Number Date New Recorded on Amendment tracking log Minor amendments to flow chart, reference to NISCHR CRC updated, committee name changes and amendment to website controller Table of Contents 1. Flow charts of procedures 1.1 SOP development 1.2 SOP distribution, maintenance and review 2. Purpose 3. Scope 4. Responsibilities 5. Procedures 5.1 Production of new SOPs 5.2 Formatting of SOPs 5.3 Naming, numbering and version control of SOPs 5.4 SOP distribution 5.5 SOP review and maintenance 6. Training 7. Glossary 8. Documents to be read alongside this procedure 9. References and SOP links 10. Appendices Appendix 1 Template BCUHB/ Health Research SOP Front Sheet Appendix 2 Health Research SOP Proposed Amendment Tracking Log Health Research SOP QA01 Version Page 2 of 12

3 Bwrdd Iechyd 1 Flow Chart of Procedures 1.1 SOP Development SOP for Work Up Author from SOP group uses template to develop SOP within agreed formatting and time frame Author sends draft SOP to SOP core writing group Reviewers where possible use Track Changes to add comments and amendments Reviewers send reviewed document to SOP controller SOP controller merges changes, corrects formatting and assigns new version number to the SOP SOP controller sends the new draft to additional reviewers if required No Changes agreed? SOP controller makes final amendments Yes Hard copy signed by Director of R&D, BCUHB and representative of Pro-Vice Chancellor for Research, SOP APPROVED Flow Chart Symbols Preparation Process Decision Terminator Document Health Research SOP QA01 Version Page 3 of 12

4 Bwrdd Iechyd 1.2 SOP distribution, maintenance and review Approved SOP SOP controller converts SOP to pdf format and uploads SOP onto appropriate web page SOP users send comments and suggestions to SOP controller for amendments SOP review triggered either by review date or significant changes Yes Revisions required? No Minor SOP controller makes minor amendments as required Major SOP group assigns author to re-draft SOP SOP does not change SOP sent to Director of R&D, BCUHB R&D and Pro-Vice Chancellor for Research, SOP enters SOP development process described in flow chart 1.1 above Flow Chart Symbols Preparation Process Decision Terminator Document Health Research SOP QA01 Version Page 4 of 12

5 Bwrdd Iechyd 2 Purpose This procedure defines the system to write, review, format, name, number, distribute and maintain this and other BCUHB/ Health Research Standard Operating Procedures. It also describes the process for periodic review of approved SOPs and verified training for SOPs. BCUHB/ R & D Standard Operating Procedures are written in compliance with current regulatory requirements and form part of the joint BCUHB/ Health Research quality system. 3 Scope This procedure applies to all BCUHB/ Health Research Standard Operating Procedures. 4 Responsibilities Role Responsibilities Health Research SOP Writing Group Writing and reviewing new SOPs according to agreed timeframes Review and revision of existing SOPs on either a scheduled or triggered basis Health Research SOP Controller Coordinating, collating and merging draft versions of SOPs Uploading approved SOPs onto website Maintaining SOP weblinks Facilitate access to Health Research SOP website Producing final versions of SOPs and sending for approvals Ensuring where appropriate SOPs are circulated to other specialist personnel Ensuring correct versions of SOPs are uploaded onto website Monitoring training records on SOPs BCUHB R&D Director Reviewing and giving final BCUHB approval of SOP Pro Vice Chancellor for Research BU Reviewing and giving final BU approval of SOP 5 Procedures 5.1 Production of new SOPs Health Research SOP QA01 Version Page 5 of 12

6 Bwrdd Iechyd Identified BCUHB/ Health Research Standard Operating Procedures will be written in agreed order of priority, determined by the Health Research SOP writing group. Members of the Health Research SOP writing group will agree on an author for each SOP. The author will use available SOP templates to develop a draft version of the SOP for review by the remainder of the SOP group. When drafting newly identified SOPs evaluation of best practice from other sources should be carried out.. Reviewers, where possible, will use Track Changes to add comments and amendments to the first draft version which will then be sent back to the SOP controller. The SOP controller will merge changes, correct formatting and add logos as required. If required a second draft of the SOP will be sent to and BCUHB stakeholders and other identified users for further comments and amendments. If there are conflicting reviewer comments these will be reconciled through discussion within the SOP writing group. The SOP controller will merge changes and amendments and then send the final version of the SOP to the Director of R&D for BCUHB and representative of Pro Vice Chancellor for Research. 5.2 Formatting of SOPs BCUHB/ Health Research SOPs will be formatted as follows: Layout Front sheet Second page Section 1 Section 2 Section 3 Section 4 Section 5 Section 6 Section 7 Section 8 Section 9 Section 10 See Appendix 1 for template. Document History and Table of Contents. Flow Charts of Procedures. Uses standard flow chart shapes. Purpose. Describes what the SOP is for. Scope. Describes who, what and where the SOP applies to. Responsibilities. Details who is responsible for the procedures described within the SOP. Procedures. Gives detailed instructions of who should do what, when and how. Training. Describes how SOP users should validate their knowledge of the SOP. Glossary. Clarifies abbreviations used in the text. Documents to read alongside this procedure. Lists other overarching and relevant documents References and SOP links. Suggested sources for further information. Appendices. Extra information attached as appropriate Fonts, headers and footers Health Research SOP QA01 Version Page 6 of 12

7 Bwrdd Iechyd Section headers will be bold Arial typeface size 14. Subheadings will be bold Arial typeface size 12. Headers and footers will be Arial typeface size 10. The remainder of the document will be Arial typeface size 12. Footers will have SOP number, SOP version number and approval date and page number of total number of pages. 5.3 Naming, numbering and version control of SOPs Naming and numbering The SOP writing group will be responsible for naming the SOPs and assigning them a category plus a sequential two digit number. SOP categories used are: B DM QA S T TM R BCUHB/ organisational Data Management Quality Assurance Safety Training Trial Management Regulatory Draft versions SOP versions are labelled clearly on the front sheet of the SOP and on the footer of each page. The author of the SOP labels the original draft version Draft Version 0 and adds the date of creation. Any further drafts of the SOP should be labelled by the author using a decimal place and the new date. (For example, Draft version ). is this done by the SOP controller or does anyone making a comment change the date? When saving the SOP to file it should be given a file name indicating SOP number, version and date. Each reviewer should add their initials to the file name before returning it to the SOP controller. (For example, QA01 Draft version JLB ) Final versions Final SOP version numbers will be indicated as single numbers plus the date. (For example, QA01 Version ). The version and date will appear on the front cover of the SOP and on the footer. When a version is approved one hard copy will be signed by the Director of R&D, BCUHB and representative of the Pro-Vice Chancellor for Research,. This copy will be filed by the SOP Health Research SOP QA01 Version Page 7 of 12

8 Bwrdd Iechyd controller. The current electronic version will include the names of approvers and date of approval. The dates for next review of SOPs will be kept in a separate log. 5.4 SOP distribution and feedback The SOP controller will upload them onto the website where they will be accessible to BCUHB and research staff. SOP users can send comments/amendments on the Health Research Quality System website to the SOP controller. The SOP controller will have discretion to escalate frequent or serious reports for discussion at SOP group meetings and a decision will be taken to do one of the following: 1) Assign the same or a new author to amend or re-write the SOP which will then go through the complete development process described above 2) SOP controller to make minor amendments, re-assign a version number and have the SOP re-approved 3) Keep the suggested amendments for implementation at a later review date. 5.5 SOP review and maintenance All SOPs will be reviewed at least every two years or earlier if there is a need to update the procedure. The designated SOP controller is responsible for timetabling and organising SOP reviews. Any user may comment on a SOP via the dedicated Health Research Quality System or R&D BCUHB web pages. All comments will be forwarded to the SOP controller, who will maintain a record of the comments to forward to the SOP group at the time of review, or initiate a revision to the SOP. The review is documented using the Health Research Proposed Amendment Tracking Log (Appendix 2) which will be retained with the signed document master as evidence of the periodic review. 6.0 Training All researchers using BCUHB/ Health Research SOPs will be expected to demonstrate their training of the SOP. SOPs are arranged on the quality system website according to the stage of research, and the role of the researcher. Weblinks will take the researcher to a Multiple Choice Question test that is specific to that researcher s role and the stage of the research project. By registering and successfully completing the test, researchers will be logged by the BCUHB R&D department as being adequately trained on the relevant SOPs they would be required to know to complete that stage of their research project. Monitoring of these training logs will be incorporated into the assessment of suitability of research team members during the research permissions process and later auditing. Health Research SOP QA01 Version Page 8 of 12

9 Bwrdd Iechyd In addition, other training activities will be in accordance with training SOPs T01 Research Quality System Training and T02 Trial Specific Training. 7.0 Glossary BCUHB BU NWORTH R&D SOP Minor change Major Changes North Wales Organisation for Randomised Trials in Health Research and Development Standard Operating Procedure Minor text change for clarification, changes that are self-explanatory, corrections to typographical errors updates to procedures with respect to change of regulations, change of working practice, change of personnel 8.0 Documents to read alongside this procedure BCUHB Research Governance Framework Policy R&D01 Code of Practice for the Assurance of Academic Integrity and Quality Assurance in Research 9.0 References and SOP Links This SOP applies to all BCUHB/ Health Research SOPs. Health Research SOP QA01 Version Page 9 of 12

10 Bwrdd Iechyd 8.0 Appendices Appendix 1: Template BCUHB/ Health Research SOP Front Sheet Version: Health Research SOP XYZ STANDARD OPERATING PROCEDURE FOR Date to be reviewed: See review log Authorship: Health Research SOP Writing Group Approved by: BCUHB R&D Group and Health Research Sub-Committee Responsible director signature: Director of R&D, BCUHB Pro-Vice Chancellor for Research, Date approved: Disclaimer: Printed SOPs are considered uncontrolled. To ensure you are working with the current version always refer to the pdf version on the Health Research Quality System website. Health Research SOP QA01 Version Page 10 of 12

11 Bwrdd Iechyd Appendix 2: Health Research SOP Proposed Periodic Review Form HEALTH RESEARCH SOP PERIODIC REVIEW FORM SOP Number. SOP Title SOP Version. SOP Effective Date... Please tick: No change Change required Classification of change Major Minor Change received Proposed By Date Proposed Amendments incorporated into Version.(enter new version number) Date Signature Health Research SOP QA01 Version Page 11 of 12

12 Bwrdd Iechyd Appendix 3: Example of relevant areas of expertise that may be considered for wider consultation of SOPs. BCUHB Research and Development Directors and Managers operational working group BCUHB Internal Review panel members Other BCUHB areas (e.g. radiology, pharmacy, pathology, information governance) BU College/School Ethics BU Planning & Governance Office BU Centre for Health Economics & Medicines Evaluation Health Research SOP QA01 Version Page 12 of 12