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{"sheet":"QE Form","index":0,"n_rows":93,"n_cols":11,"rows_kept":93,"cut":false,"hidden":false,"merged":[[0,1,3,1],[40,0,40,1],[33,0,33,1],[57,0,57,1]]}
["Quality event form","This form captures information about quality events. These are deviations from intended or expected study processes. A quality event can be a breach of the study protocol or GCP, an  administrative error in study documentation, or some other kind of divergence from expected study standards that might in some way impair research quality. For more information on this form, see the RG Quality event form – Guidance Note. For more information on the Research Governance procedure for quality events, see RG SOP 8 – Quality events.\n\nThe user should input information about the event using the fields below. The form will then  prompt either a Breach Report, Note to File form or neither, depending on the information provided. The form will also provide guidance on when to seek further advice, and whether and how to file and report onwards these forms.\n\nFor questions about this form, or to provide feedback, please write to research-governance@bristol.ac.uk.\n\nLocal versions of this template form are uncontrolled. For the latest version, please see https://www.bristol.ac.uk/research-enterprise-innovation/research-governance/SOPs/",null,null,null,null,null,"YES","YES","A)","ACTUAL"]
["Research Governance Team",null,null,null,null,null,null,"NO","NO","B)","POTENTIAL"]
["University of Bristol",null,null,null,null,null,null,"UNSURE",null,"UNSURE"]
["v1.3 24/04/2025\n\n"]
[]
["A – EVENT BACKGROUND"," "]
["Submitter information"]
["A1 – Name"]
["A2 – Role"]
["A3 – Date"]
[]
["Quality event background"]
["A4 – Study title"]
["A5 – Study acronym/short title","If applicable"]
["A6 – Sponsor"]
["A7 – Sponsor reference"]
["A8 – IRAS ID"]
["A9 – REC approval reference"]
["A10 – Chief Investigator"]
["A11 – Site name","If applicable"]
["A12 – Principal Investigator","If applicable"]
["A13 – Date of event"]
["A14 – Date investigator/research team made aware of event"]
["A15 – Event reference number","If internal reference numbers are used by study team"]
["A16 – Number of participants affected by event","If applicable"]
["A17 – Participant ID number(s)","If applicable"]
[]
["A18 – Summarise the event\n\nProvide a summary, including what happened, how it was identified, the steps taken to determine the extent of the situation, the sites involved, and any mitigating factors.  Describe who did what, when, why and how, with references to job roles, or names as initials only. Information should be ordered chronologically."]
[]
["B – EVENT CLASSIFICATION"]
["B1 – Does the event involve a Personal Data Breach\n\n A Personal Data Breach is defined in the Data Protection Act 2018 as “a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed”."]
[]
[]
["Suspected Data Breaches must be reported to data-protection@bristol.ac.uk immediately. If you are unsure whether the event is a Data Breach, you should still seek advice at this email address."]
[]
["B2 – Is the event: \n\nA) One or more of:\n- A deviation from the intended processes set out in the study protocol or IRAS application\n\n- A breach of, or non-compliance with, the principles of Good Clinical Practice (https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline) \n\n- A breach of, or non-compliance with, the principles of the UK Policy Framework for Health and Social Care Research (www.hra.nhs.uk/media/documents/Final_Accessibility_uk-policy-framework-health-social-care-research_.pdf)\n\nB) None of the above"]
[]
["If you are unsure what kind of event this is, please contact the Research Governance Team for advice as soon as possible."]
[]
["C – FILE NOTE"]
["Based on your answers, this is a non-breach quality event and requires a File Note be added to the Trial Master File. Please complete the below fields and file the PDF output according to study procedures. The PDF should be created using instructions in the corresponding spreadsheet tab below. All Notes to File must be made available to the Sponsor on request.\n\nThe Research Governance Team periodically reviews File Notes to ensure Breaches have not been misclassified. If you believe the event breaches intended processes set out in the study protocol or IRAS application, the principles of Good Clinical Practice or the UK Policy Framework, please adjust your answer above."]
[]
["C1 – Summary of discussions and agreed actions\n\n\n\n\n\n"]
[]
["C2 – Has the incident resolved/been resolved"]
[]
["C3 – Describe the resolution\n\n\n\n\n\n"]
[]
["C4 – What steps are being taken to resolve the incident\n\n\n\n\n\n"]
[]
["C5 – Please describe any supporting documents you are attaching to this form\n\n\n\n\n"]
[]
["C6 – Where in the Master File will this File Note be stored\n\n\n\n\n\n","If applicable"]
[]
["C7 – Additional comments\n\n\n\n\n\n","If applicable"]
["This section of form is complete. You can now export the form to pdf and file according to study procedures."]
["D – BREACH REPORT"]
["Based on your answers, this quality event is a Breach and requires a Breach Report. This must be reported to the Sponsor within 24 hours of your becoming aware of it. Please complete the below fields and send the Excel document to the Research Governance Team using the process agreed during study setup (if no process has been formally agreed, please contact Research Governance)."]
[]
["D1 – Root cause analysis\n\nExplain how and why the Breach occurred, and assess whether the cause was isolated or systematic.\n\n\n"]
[]
["D2 – Corrective actions\n\nExplain the measures taken to correct the situation.\n\n\n\n"]
[]
["D3 – Preventative actions\n\nExplain the measures taken to the prevent the situation occurring again in future.\n\n\n"]
[]
["D4 – Does this meet the criteria for a Serious Breach\n\nA Serious Breach is a Breach of \"the conditions and principles of GCP in connection with that [research, or] the protocol relating to that [research that was] likely to effect to a significant degree – (a) the safety or physical or mental integrity of the [participants]; or (b) the scientific value of the [research]\".\n\nNote, a Breach still qualifies as serious if it did not actually have a significant effect in the sense above, but was likely to do so at the time of the event’s occurrence.\n\nThis definition should not be interpreted overly narrowly. A breach that risked or incurred harm to non-participants might still require classification as serious, and the associated onward reporting."]
[]
["D5 – Is this Breach serious because of actual or potential impact"]
[]
["This section of form is complete. Please save the Excel document as an Excel Spreadsheet without macros enabled (.xlsx) and send to Research Governance for Sponsor Assessment."]
[]
["The remainder of this form is only to be completed by, or at the request of, the Sponsor Representative. "]
[]
["E – SPONSOR ASSESSMENT"]
["This section of the form is only to be completed by, or at the request of, the Sponsor Representative. "]
[]
["E1 – Does this require reporting to the REC"]
["E2 – Date reported"]
["E3 – Does this require reporting to the MHRA"]
["E4 – Date reported"]
[]
["E5 – Does this require CI assessment"]
[]
["E6 – Additional comments\n\n\n\n\n\n","If applicable"]
[]
["E7 – Reporting individual"]
["E8 – Date"]
[]
["E9 – CI name"]
["E10 – Date"]
[]
["E11 – Sponsor representative name"]
["E12 – Date"]

{"sheet":"FAQs","index":1,"n_rows":17,"n_cols":1,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
["Microsoft is preventing me from enabling the macros in the form"]
["Ensure you have opened the form using the desktop app, rather than the browser version of Excel. \n\nUpon opening the app, you may receive a yellow 'Enable editing'  and a further yellow 'Enable Content' prompt at the top of the screen. Both of these can be accepted.\n\nYou may then receive a prompt to Trust the document, its location, or similar. This can also be accepted.\n\nOccasionally, you may receive a red 'Security risk' macro warning in place of the yellow warning described above. This can be manually disabled using the 'Remove Mark of the Web' instructions here: https://learn.microsoft.com/en-us/microsoft-365-apps/security/internet-macros-blocked#guidance-on-allowing-vba-macros-to-run-in-files-you-trust\n\nAlternatively, navigate to the following Research Governance folder on the University SharePoint, and copy the file to your OneDrive or SharePoint by selecting the three dots next to the file name, and selecting 'Copy to'. \n\nhttps://uob.sharepoint.com/:f:/t/grp-researchgovernance/EmB6JP3Uf89FncsTm8DdQ8IBbiifM-aFZ5OU15PbYZ6vgA?e=aGKIIO\n\nWhen opened in the desktop Excel app, the file should now have full functionality.\n\nIf you have any questions, please write to research-governance@bristol.ac.uk"]
[]
["I've sent the form output to someone but they didn't receive it"]
["Some organisations block receipt of emails with macro-enabled spreadsheets (.xlsm format) attached. Make sure you've exported the file to spreadsheet format (.xlsx) or .pdf."]
[]
["I've partially completed the form but I'll need to amend it in future"]
["If the form isn't fully completed, or you think it's likely to need revision, save in .xlsm format to preserve the macro-enabled parts of the form. To create a copy, use 'Save As' and give the document an alternative name. Be aware that saving as .xlsm may cause difficulties in sharing with other organisations (see above)."]
[]
["I'm ready to create a new quality event but information from the previous one is still in the form"]
["Use the 'Reset form' button, though this will overwrite any information currently in the form (see above)."]
[]
["I want to export the form to pdf"]
["To export the form to pdf, either use the button at the conclusion of the note to file report, or follow these steps.\n\n1. Navigate to the 'QE form' tab of the spreadsheet.\n2. Select 'File'\n3. Select 'Print'\n4. In the printer options, select 'Microsoft Print to PDF'\n5. In the printer options, select landscape orientation.\n6. In the printer options, select 'Fit All Columns on One Page' under scaling.\n7. Select 'Print'."]
[]
["I've received some kind of error message when using the form"]
["Triple check that all macros are enabled. \n\nIf they are, and you're still receiving an error code, check cells B14 and B24. When populated, these are used by the form to generate a filename upon exporting the form to .xlsx or .pdf. Therefore if these fields contain characters or strings forbidden within filename conventions (for instance, use of '!', ':', starting the string with an underscore) the export function will not run. \n\nIf you have tried both the above and are still receiving an error, contact the Research Governance Team for advice."]

{"sheet":"Changelog","index":2,"n_rows":4,"n_cols":3,"rows_kept":4,"cut":false,"hidden":false,"merged":[]}
["Date","Version","Changes"]
["2025-04-24","v1.3","Fixed errors in export functionality."]
["2025-04-08","v1.2","Improved ability of fields to expand to fit text; restored filename generation functionality and added error information; corrected inconsistent formatting."]
["2025-03-07","v1.1","Fixed bug in exporting to pdf/xlsx functionality."]