SOP01a: Standard Operating Procedure for Developing, Reviewing and Approving Standard Operating Procedures

Transcription

1 SOP01a: Standard Operating Procedure for Developing, Reviewing and Approving Standard Operating Procedures Authorship team: Ian Russell for Joint SOP Group on Trial Administration (viz Angela Evans, Sarah Gaze, Hayley Hutchings, Kathy Malinovszky, Anne Seagrove, Marie Thomas). Approved by WWORTH Joint Executive Group: (Ian Russell in chair) Signature: Date: 11 September Version record Version number Effective date Reason for change 0 16 Jan 2009 Derived from SOP approved by NWORTH Jan 2009 Reviewed by TAF A on 23 January Feb 2009 Reviewed by TAFs P & T on 30 Jan & 4 Feb Feb 2009 Informally reviewed by WDG on 13 Feb Mar 2009 Reviewed by TAF A on 19 Feb 09 & others Jun 2009 Updated to accord with UKCRC Core SOPs Jul 2009 Reviewed by TAF A on 18 June Jul 2009 Approved by WDG 10 Jul 09 subject to amendment Aug 2009 Updated for UKCRC registration application Sept 2009 Approved by WDG for use in practice May 2010 Minor formatting amendments Oct 2012 Reviewed after 3 years in practice Jul 2013 Amendments to header and roles 2 21 Jan 2014 Authorised by JEG subject to amending flowchart May 2014 Remove training log post JSOPG discussion - MS & CS WWORTH-SOP01AonSOPsV Page 1 of 11 Not guaranteed if printed

2 1 Table of Contents 0 Version record Table of Contents Glossary Introduction Purpose Roles and Responsibilities Procedure Flow chart for developing, reviewing and approving a SOP SOP document control Standard structure and content for SOP Process for reviewing and approving a SOP in development Circulating & disseminating a SOP Training in a SOP Process for reviewing and updating an approved SOP Relationships between SOPs Modified Operating Procedures Training Plan References Related SOPs...11 WWORTH-SOP01AonSOPsV Page 2 of 11 Not guaranteed if printed

3 2 Glossary The full Glossary is in Swansea University H drive/documents/526 WWORTH/Development Group/Glossary. 3 Introduction Standard Operating Procedures (SOPs) are succinct formal documents designed to achieve consistency in specified trial functions by specifying standard practice in performing those functions (GCP 1.55 & [1]). While SOPs should cite relevant legislation & regulations, and key references & evidence, they need not expound theory. This document is the first SOP of the West Wales Organisation for Rigorous Trials in Health (WWORTH). It describes the roles, responsibilities and actions of individuals developing and approving SOPs. We are grateful to colleagues in the North Wales Organisation for Rigorous Trials in Health & Social Care (NWORTH) for access to their SOP on SOPs [2]. WWORTH SOPs must accord with all relevant regulations, including the European Union Clinical Trial Directive, the ICH guideline for Good Clinical Practice (GCP) and the current NHS Research Governance Framework. They will seek to distinguish between regulations for CTIMPs and for other research. They should reflect best practice in clinical trials conducted by Swansea University, ABM UHB and HDd LHB. [This paragraph epitomises an important principle in writing SOPs for WWORTH: must denotes aspects of trial practice required by formal legislation or regulation; will denotes aspects recommended by GCP; and should denotes aspects recommended by WWORTH.] 4 Purpose The purpose of this SOP is to describe the process of structuring, developing, labelling, approving, circulating, disseminating, reviewing, re-reviewing, updating and modifying SOPs within WWORTH. Its scope is to address all the issues specified as typical of a SOP on SOPs in the document Core SOPs for UKCRC Registered CTUs circulated by UKCRC in April Roles and Responsibilities Everyone writing, editing, reviewing or modifying SOPs for, or in collaboration with, WWORTH is responsible for getting training in this SOP and working according to it. WWORTH Director has general responsibility for academic and technical WWORTH-SOP01AonSOPsV Page 3 of 11 Not guaranteed if printed

4 aspects of developing, approving, improving and disseminating the SOP portfolio, including training. WWORTH Manager will have delegated responsibility for managing, documenting, and implementing the SOP portfolio, including the oversight of training, notably by strategic version control through the 1st digit, eg 1.2. WWORTH Quality Assurance Officer has delegated responsibility for assuring the quality of the SOP portfolio, including the organisation of training and the monitoring of adherence. The main author is responsible for writing and, in principle, updating the SOP according to this SOP, reviewing and considering current best practice across the UK, and tactical version control through the second digit, eg 1.2. Other authors are responsible for collaborating with the main author, typically by writing a subsection for, or editing, the current version, and adding date in the form YYMMDDinitials to the current version number when editing, eg DEF. The reviewer is responsible for rigorously and independently reviewing and presenting the SOP, and making a recommendation (viz approve, approve subject to minor revision, request major revision or request review by WWORTH Joint Management Group ), usually to the Joint SOP Group. 6 Procedure When the WWORTH Joint Management Group or Director identifies a need to write a new SOP or update an existing SOP, and they or the Joint SOP Group appoint author(s) and reviewer(s), the latter should use this SOP. WWORTH-SOP01AonSOPsV Page 4 of 11 Not guaranteed if printed

5 6.1 Flow chart for developing, reviewing and approving a SOP Either WWORTH identifies need to develop or review specified SOP Or 1 year has elapsed since 1st approval in principle Or 2 years have elapsed since previous approval in practice JSOPG appoint authors & reviewer Author(s) draft SOP 2/52 before review meeting Reviewer reviews & distributes SOP 1/52 before review meeting Recommendation agreed by review meeting Request major revision Approve without change Approve with minor revisions 1/52 for extra comments from JSOPG etc Main author and reviewer sign SOP 1/52 for final comments from JSOPG etc Authors redraft SOP WWORTH chair signs off SOP and sets review date Authors revise SOP Implement training plan & log Trainer & trainees sign training log SOP effective Figure 1: Flowchart from Section 6.1 WWORTH-SOP01AonSOPsV Page 5 of 11 Not guaranteed if printed

6 6.2 SOP document control The current version number of every SOP, specifically the first digit, shows where its development has reached: versions 0, still in initial development, use the watermark in development and the same footer; versions 1, approved in principle after detailed consideration usually by the Joint SOP Group, use the watermark approved for use and the footer not valid if printed ; versions 2, approved after review of their use in practice usually by the JSOPG, use the watermark authorised for use and the footer not guaranteed if printed ; and versions 3 have completed their first biennial review. The WWORTH Director labels each proposed SOP and tells the specified author. If version 0 of this WWORTH SOP arises from an SOP developed elsewhere, the Director sends that version, appropriately labelled, to the specified author. If not, ie the SOP represents new work, the Director sends only the label. In due course the WWORTH Manager will take responsibility for labelling. SOP labels comprise the characters WWORTH-SOP, two-digit SOP number (currently between 01 and 39), SOP name, version number, hyphen and date in the form YYMMDD to ensure that Windows Explorer arranges successive drafts in date order. For example the label of this SOP, which appears in every page footer, is WWORTH- SOP01AonSOPv As the Version Record on the front of this SOP illustrates, the first digit of the version number is 0 while the SOP is in development, 1 once approved in principle, 2 once approved in practice,and 3 after the first biennial review. This digit is the responsibility of WWORTH Director or Manager acting on behalf of the WWORTH Joint Management Group. The second digit of version number, after the decimal point, charts the progress of drafting or updating the SOP. It is the responsibility of main author ABC to increase it by 1 whenever he or she issues a complete new draft. When author DEF edits, or comments on, the current version, he or she should update and add his or her initials, eg DEF. If author GHI adds more edits or comments, he or she should also update and add initials, eg DEF-GHI. If the main author replies to this dialogue WWORTH-SOP01AonSOPsV Page 6 of 11 Not guaranteed if printed

7 without issuing a complete new draft, he or she should also add initials, viz eg DEF-GHI-ABC. Where a SOP is modified for a specific trial, the trial acronym should be the first set of initials. If the COnStRUCT Trial Management Group were to decide to modify this SOP, for example, it would become eg WWORTH- SOP010onSOPv COnStRUCT. 6.3 Standard structure and content for SOP Use all sections of the current SOP template (of which this SOP is an exemplar), in particular the following headings: 0. Version Record record version numbers, effective dates and reason for change, ideally in one line 1. Table of Contents 2. Glossary if possible use (if not adapt & report adaptation) the generic WWORTH glossary (full list in Swansea University drive H/Documents/526 WWORTH/Joint SOP Group/Glossary) 3. Introduction identify legal or regulatory or other requirements for this SOP 4. Purpose and scope identify the purpose and scope of this SOP 5. Roles and responsibilities identify all those responsible for using this SOP 6. Procedure describe this operating procedure in a logical sequence in Plain English, starting with a flow chart 7. Training plan create a plan to ensure effective implementation of this SOP 8. References include all key references but avoid marginal references 9. Related SOPs specify SOPs to be read in conjunction with this SOP 10. Appendices include a training log template WWORTH-SOP01AonSOPsV Page 7 of 11 Not guaranteed if printed

8 6.4 Process for reviewing and approving a SOP in development The main author should send the version for review to the reviewer (appointed in advance and by mutual consent usually by Joint SOP Group) at least 2 weeks before the scheduled meeting for reviewing it (usually a meeting of the Joint SOP Group). The reviewer should propose major changes in Comments, suggest minor corrections in Track Changes, and ensure with the WWORTH secretariat that the resulting version reaches all those entitled to attend the scheduled review meeting (usually members of the Joint SOP Group) at least one week before that meeting. After considering the reviewers recommendations, the discussion at the review meeting, and electronic comments received before the meeting, the review meeting will choose one of four recommendations: A B C D Approve without revision at the next meeting of WWORTH Joint Executive Group the Chair will sign the SOP for implementation. Approve subject to minor revision main author will make the agreed revisions, consider any other suggestions received within one week of the review meeting, and send the resulting SOP to WWORTH Director or Manager for signature at the next meeting of WWORTH Joint Executive Group and implementation. Request major revision authors will redraft the SOP for 2nd review meeting. Request review by WWORTH Joint Management Group - at its next meeting when SOP raises issues of principle. 6.5 Circulating & disseminating a SOP WWORTH will circulate pdf versions of approved SOPs, initially by putting them onto Swansea University s shared drive H/Documents/526 WWORTH/Approved SOPs, thereafter onto a SharePoint site shared with both NHS Trusts, and eventually onto the WWORTH web site. All approved and developing SOPs will be accessible by members of WWORTH, defined as staff engaged in clinical trials within Swansea University, Abertawe Bro Morganwg University Health Board or Hywel Dda Local Health Board that have been adopted by WWORTH. WWORTH-SOP01AonSOPsV Page 8 of 11 Not guaranteed if printed

9 6.6 Training in a SOP All WWORTH staff, and members of the research teams of adopted trials, must undertake the appropriate generic and trial-specific training to ensure they meet the training requirements mandated by their employers, GCP and the needs of the specific trial. For example, all new employees of Swansea University must attend induction, and fire and safety training as well as role-specific training like laboratory safety. The WWORTH Manager should identify, and arrange for new staff to attend, the necessary courses as soon after appointment as feasible. In consultation with CI and TM the WWORTH Manager should identify all the SOPs relevant to a specific trial in which the new member of staff should be trained. The WWORTH Manager or SOP author should train trial staff, either in groups or one to one as appropriate. Trial-specific training should be recorded in TMF or TSF as appropriate and in individual training records. The WWORTH Manager should ensure that these individual records comply with the employer s requirements. When tasks specified in SOPs are delegated to WWORTH staff, TMs, PIs or CIs, they must ensure they have attended the relevant GCP training course and keep up to date through refresher courses. It is the responsibility of CIs and PIs to ensure that all staff allocated duties in delegation logs are suitably trained to fulfil those duties (WWORTH SOP16 Site Setup, Appendices 9 and 10). Each trial should maintain a central training log and ensure that WWORTH has access to that log, not least to integrate the logs of staff who work on more than one trial. Similarly trials should ensure that each site maintains a local training log, not least to integrate the logs of staff who work for more than one sponsor. Each SOP will have a training plan and a training log to designate the trainers for that SOP and monitor the training they deliver. When possible the trainers for each SOP should include the authors of that SOP (of whom there are often two) and at least two members of WWORTH core staff (who should be authors or trained by authors). Training for a typical SOP will be in two stages. First training in the principles of that SOP will take place within a small group led by a designated trainer for that SOP. Second training in using that SOP in practice will take the form of regular supervision by an experienced trialist (ideally a designated trainer). Both trainer and trainee will sign the log (see WWORTH SOP02 Training) to confirm that training is complete. During the development phase of a trial, the CI, available PIs and potential staff will review relevant SOPs for guidance and training. Once the trial receives funding and appoints a Trial Manager or Trial Coordinator, he or WWORTH-SOP01AonSOPsV Page 9 of 11 Not guaranteed if printed

10 she will receive training in those relevant SOPs, ideally from a designated trainer. To help individual staff record training for the purpose of their Continuing Professional Development, and help individual trials and WWORTH record training for quality assurance, WWORTH will aggregate training logs by individual within trial. 6.7 Process for reviewing and updating an approved SOP All SOPS are due for review every two years, or earlier if there are significant changes in legislation or circumstances. We encourage users to comment on SOPs whenever salient. Please send electronic comments to WWORTH Director or Manager with a copy to the author(s). 6.8 Relationships between SOPs To ensure consistency between SOPs, WWORTH will maintain and circulate a matrix of relationships between SOPs. All authors should use their rows to suggest SOPs to which they believe their SOP is related, and their columns to confirm the suggestions of other authors. Once suggestions are confirmed, both authors should have the opportunity to comment on the other SOP in person or in writing at every scheduled review of that SOP if possible. To minimise overlap between SOPs, WWORTH will maintain and circulate an alphabetical index of subsection titles from contents tables. If either the relationships matrix or the contents index identifies inconsistency or overlap between SOPs, the SOP authors should resolve this in consultation with the WWORTH Director or Chair of the JSOPG. If the contents index identifies a topic omitted from all SOPs, the WWORTH Director will propose where it should appear, in consultation with the Chair of the JSOPG and relevant authors. 6.9 Modified Operating Procedures If an operating procedure is specific to only one trial associated with WWORTH, it should take the form of a MOP derived from the most relevant currently approved SOP(s) or the current SOP template (Subsection 6.3). Though CI and trial coordinator will lead development, the process should otherwise follow this SOP. Final approval should be jointly by the CI and WWORTH Director. Such a MOP may also be appropriate in specific circumstances like the Joint Clinical Research Facility or the Joint Clinical Imaging Unit. 7 Training Plan Training in the principles of this SOP will take place within a small group led by (or one to one with) a designated trainer for this SOP. Training in the practice WWORTH-SOP01AonSOPsV Page 10 of 11 Not guaranteed if printed

11 of developing a specific SOP or MOP will take the form of regular supervision from an experienced trialist, culminating in the approval or authorisation of that SOP. In due course new members of WWORTH will receive personal training on this SOP from the WWORTH Manager. WWORTH will record training in a log (see WWORTH SOP02 Training), and aggregate all such logs by individual within trial. 8 References 1. European Medicines Agency (2002). Guidelines for Good Clinical Practice. London: EMeA. (CRMP.ICH/135/95) North Wales Organisation for Randomised Trials in Health (2007). Standard Operating Procedure for Developing, Reviewing and Approving SOPs. Bangor: NWORTH. 9 Related SOPs All other WWORTH SOPs, notably strategic SOPs on sponsorship of trials (typically by Swansea University) and the adoption of new and existing trials by WWORTH. WWORTH-SOP01AonSOPsV Page 11 of 11 Not guaranteed if printed