Guidance for Quality Control (QC) of CTU Study Document(s)

Transcription

1 Document type Keele University Health and Social Care QMS: Guideline Version No. 1.0 Version Date 20 July 2018 SOP index number HSCR-GUI10 Guidance for Quality Control (QC) of CTU Study Document(s) Author(s) CTU Project Management Team Signed hard copy stored in approved SOP file with Research Integrity Office 20-Jul-2018 Susie Hennings Disclaimer Once printed from PDF, this document is an unofficial copy. All SOPs and associated documents must only be accessed through the dedicated SOP area of the Keele University Research Toolkit webpage to ensure the correct version is being used. The user must ensure that they are working to the current version of this document. Version History Log Version Date Reason for change Jul-2018 New guidance document Page 1 of 5

2 Contents Section A Introduction... 3 Section B QC of Study Documentation... 3 Section C References... 5 Page 2 of 5

3 Section A Introduction A1 Once all documents for inclusion within ethical and regulatory applications have been developed for a study and their content has been agreed by the relevant members of the Trials/Study Management Group (TMG), these documents must undergo the CTU process of Quality Control (QC). This QC process helps to maintain the high standard of documentation and also ensure consistency throughout the study itself. A2 An effective QC process also helps to ensure that timelines can be maintained and resources used efficiently, avoiding future corrective protocol or supporting document changes. PLEASE NOTE: Documents should remain in draft version until all comments (including Sponsor comments) have been satisfactorily addressed and the documents are ready for regulatory submission. Section B QC of Study Documentation B1 It is recommended that the QC process is conducted in 2 stages; QC of the study protocol to a near final state followed by QC of other study documents, however, the CI/AI may wish to conduct these stages together. The decision on how this process is to be conducted should be documented (e.g. recorded in TMG minutes or on the CHL13: Standard Checklist for Quality Control). PLEASE NOTE: Significant changes to all documents should be avoided at this QC stage (where possible). B2 The Chief Investigator (CI) / Associate Investigator (AI) should outline which members of the study team should be included in the QC process (and may include different members for review of the protocol and review of the study documentation). This must include as a minimum the Senior Trials Manager (STM), the Lead Statistician and the CI. This may require further discussion and agreement at a TMG meeting. The final members of the study team to be included in the QC process should be documented (e.g. recorded in TMG minutes or on the CHL13: Standard Checklist for Quality Control). B3 The CI / AI should be the last person to complete the QC review. In addition to their own review, the CI / AI should adjudicate on the comments and queries raised by other members of the team. The decision to accept or reject changes suggested by other members of the team should be recorded by the CI / AI on the reviewed document. This ensures that there is transparency in decision making, and decision making can be recorded. B4 QC includes checking the following: content; format; font; spacing; layout; spelling errors; question numbering; image / logo placement etc. (N.B. For documents, e.g. letters, which are to be produced by the database, the focus of QC should be on content, as formatting etc. will be finalised during database testing (post-regulatory approvals)). B5 QC may be completed either as a paper copy or electronically, for example via (options outlined below) or by uploading to a secure shared drive. B6 Coordination of this QC process is usually performed by the SC or TM within the CTU whereby the near final draft documents are made available according to what has been agreed by the CI / AI (regarding who should be included in the QC process and how this is going to be conducted (paper or electronically via or shared drive(s) or a combination of methods)). The QC Page 3 of 5

4 process agreed should be clearly documented (e.g. recorded in TMG minutes or on the CHL13: Standard Checklist for Quality Control). See below of examples of how this could be conducted: Paper CHL13: Standard Checklist for Quality Control (one checklist per person reviewing) placed at the front of a folder and information regarding who the folder is to be circulated to should be added. Print all current final draft documentation and place the paperwork in a folder, suitably in order, divided into sections. If the circulation is for supporting documents only, the contents of the folder should also include the near final draft of the Study Protocol, flow diagram and any other (draft) documents deemed relevant by the study team (these documents should be used for reference only at this stage no further changes should be made). The folder should then be passed between all the relevant individuals who are required to review and provide feedback. Electronic CHL13: Standard Checklist for Quality Control An is circulated outlining all relevant individuals who are required to give feedback according to that agreed by the CI / AI. This is usually sent by the SC / TM. Depending on the preferred process, all current final draft documentation are attached to an or uploaded to a shared drive*, (each suitably named for easy identification). If the circulation/upload is for supporting documents only, the near final draft of the Study Protocol, flow diagram and any other (draft) documented deemed relevant by the study team should also be included (these documents should be used for reference only - at this stage no further changes should be made). Depending on the preferred process, the relevant individuals (either at the same time or co-ordinated in a specified order) should review and provide feedback using the same document. PLEASE NOTE: Changes MUST be tracked via tracked changes or an edit function. Once completed, the individual signs the QC sheet to confirm they have commented (or have reviewed it and have no comments), and passed the folder onto the next person on the list, who then completes the same process. Depending on the preferred process, the relevant individual(s) once completed their review should reply via to confirm they have performed their review. Where is being used the reviewer should reply all and should attach the updated documents with their comments (or indicate they have reviewed the document(s) and have no comments). This is so that the next reviewer is using the most up to date version of the document or so that comments can be compiled. When all individuals have completed the QC process, the folder and its contents are returned to the TM / SC. When all individuals have completed the QC process, the TM / SC collates all feedback. *PLEASE NOTE: Googledrive/Googledocs/Dropbox are not secure shared drives/folders, therefore the use of these drives should be assessed regarding the sensitive nature of the information being uploaded which should be considered when deciding which process to use. Page 4 of 5

5 B7 Once all comments/suggested changes have been made throughout the QC process the SC/TM addresses this feedback using the CI s/ai s final decision on changes to the protocol/study documents. Any queries on any decisions will be relayed back to the CI/AI for a final decision. B8 After all comments have been addressed, please refer to SOSOP01: Sponsorship, Regulatory Approvals and Green Light section D2 Application for Sponsor Review Prior to Submission of Regulatory Applications. PLEASE NOTE: There will be other documents (CVs, contracts, etc.) that require to be compiled for Sponsor/Regulatory submission that are not part of the QC process this process is outlined in SOSOP01: Sponsorship, Regulatory Approvals and Green Light. Section C References None Page 5 of 5