Bath Research and Development Audit / Monitoring of Approved Research Studies

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1 Audit / Monitoring of Approved Research Studies Introduction Under the Research Governance Framework for Health and Social Care, Consortium office has a responsibility to monitor and audit research studies conducted on its premises; additionally under ICH-GCP it has a responsibility to monitor and audit studies for which it is sponsor. As a result the Consortium has designed and implemented processes to meet these requirements: Purpose - The purpose of monitoring and audit is to ensure that: The rights and well being of subjects participating in the study are protected The conduct of the study is in compliance with the Research Governance Framework, with the current approved protocol/protocol amendments, with Good Clinical Practice (GCP) and with the appropriate regulatory requirements. The Audit / Monitoring process consists of three components 1. Identification of 10% of the total number of projects approved each year, for annual audit throughout the life of the project. The full process for this is outlined below. 2. Follow up of this 10% and completion of an end of study report will be requested and pursued. For non commercial, academic studies, this final report will normally be posted on our website, and studies of particular interest will be publicised more widely via the newsletter and annual reports to the DH. 3. Confirmation of completion of all studies will be sought and pursued. This will enable us to update our database accordingly so that an accurate record of numbers of studies will be available. 1. Identification of studies for Auditing / Monitoring Audit of projects involves an annual monitoring exercise, during which a progress report will be requested. 10% of all studies that are approved in the office will be selected for Audit. Criteria. Studies that meet any or all of the following criteria may be selected for monitoring: Projects for which any of the Consortium PCTs or the are acting as sponsor All project deemed suitable for audit by the RM&G manager at the point of approval, or by the PCT during the approval process Beyond this, further studies will be selected at random to ensure that a full 10% of those approved are audited. The criteria set out above will not be considered exhaustive and studies may be selected for monitoring on the basis of individual circumstances alone. Whilst the criteria above may be used to identify studies, the individual reason for the Consortium staff selecting a study for monitoring will not be disclosed. Staff concerned about study conduct or compliance of a study with the Research Governance Framework may request that a study is monitored by ing the Consortium, on brd@bath.ac.uk Audit / Monitoring Process After identification of the studies to be audited on an annual basis, letters will be sent to Chief Investigators, explaining the audit process (see appendix 1) A blank template for this annual report will be provided electronically this will be accessible via the Consortium website so that Chief Investigators can provide the required information by . A strict word limit will be indicated. For studies with high data risk concerns, a separate audit report will also be required. Page 1 of 6

2 The Consortium staff will ensure that the annual report is rigorously reviewed, particularly in relation to the original aims and objectives, timelines and performance indicators stipulated in the protocol at the outset of the work. Annual reports on those projects that are progressing as expected will be filed and the Chief Investigator informed. For projects where significant deviations from original plans are identified a process will be introduced that is designed to improve the conduct of the work. Recommendations will be made on a case-by-case basis. Where necessary site visits will be organised. The findings of each site visit will be collated and a visit report produced; this report will be sent to site within two weeks of the visit and will include but not be limited to the following: The date(s) of the visit The site The names of all individuals present A list of all findings observed by Consortium staff during the visit Recommendations for any actions that the site staff should take in order to address the findings, where possible these recommendations will be developed in conjunction with site staff References to any applicable sections of the ICH-GCP guideline A summary of the visit The Chief Investigator / Principal investigator will be required to provide the Consortium with a response within two weeks of receiving the report. This response should detail the actions taken/actions to be taken to remedy the shortcomings identified. The Consortium staff may request evidence that these actions have been undertaken and in addition to this a further visit may be undertaken if necessary. The ultimate sanction is for withdrawal of NHS R&D approval in cases where progress in terms of addressing shortcomings is negligible or misconduct is evident. 2. End of Study Reports Beyond the Annual Audit / Monitoring of 10% of all projects approved, stage 2 involves the collection of End of Study reports from these Audited projects. A letter will be sent out three months before the end date of these projects requesting this final report. The report template will be available in electronic format and again a word limit will be specified. Two versions of the request letter are available - one for commercial research, one for non commercial research (appendix 2 and appendix 3).The latter will include an additional paragraph informing the researcher that a selection of the final reports on academic studies will be posted on a dedicated section of the website. Researchers will be given the opportunity to object to this. All final reports should be submitted to the office within three months of study completion, to allow for information of publications and planned publications to be included. 3 Confirmation of end of study Each week, all studies that are due to finish will be identified. One month later, a letter will be dispatched (appendix 3), asking for confirmation that the study did indeed finish when predicted, or if the end date has changed, confirmation of the new completion date will be sought. This will enable the Consortium administrator to keep the data base up-to-date and complete. Care will be taken in terms of ensuring that requests for annual reports are not requested on studies that are due to finish within the next four months. In these cases, the annual report is not necessary as the end of study report will be provided within seven months, and covers essentially the same information. Page 2 of 6

3 APPENDIX 1 ANNUAL PROGRESS REPORT ON RESEARCH STUDIES The annual progress report for the project detailed above is due for submission to the Bath Research and Development Consortium office by XXX. This report is required by the Consortium under the terms of Trust R&D approval, and to fulfil our obligations under the Research Governance Framework. The information we require is shown on the attached template. Please note that you can access this template, complete the necessary information, and send the form back to us electronically. A blank template is available on our website at Please limit your responses so that the word count of the completed template is no more than 1,500 words, and return the completed form by to: brd@bath.ac.uk I look forward to hearing from you by XXX and receiving your completed annual report. If you have any questions, please do not hesitate to contact me. Page 3 of 6

4 APPENDIX 2 FINAL REPORT ON COMMERCIAL RESEARCH STUDIES The final report for the project detailed above is due for submission to the Consortium office by XXX. This report is required by the Consortium under the terms of Trust R&D approval, and to fulfil our obligations under the Research Governance Framework. The information we require is shown on the attached template. Please note that you can access this template, complete the necessary information, and send the form back to us electronically. A blank template is available on our website at Please limit your responses so that the word count of the completed template is no more than 1,500 words, and return the completed form by to: brd@bath.ac.uk I look forward to hearing from you by XXX. If you have any questions, please do not hesitate to contact me. Page 4 of 6

5 APPENDIX 3 FINAL REPORT ON ACADEMIC RESEARCH STUDIES The final report for the project detailed above is due for submission to the Consortium by XXX. This report is required by the Consortium under the terms of Trust R&D approval, and to fulfil our obligations under the Research Governance Framework. The information we require is shown on the attached template. Please note that you can access this template, complete the necessary information, and send the form back to us electronically. A blank template is available on our website at Please limit your responses so that the word count of the completed template is no more than 2,000 words, and return the completed form by to: brd@bath.ac.uk We plan to post a selection of these final reports on a dedicated section of our website, so that the wider research community has access to clear information about research that has been undertaken within the Consortium. I trust that this meets with your approval, but if this does raise any issues, or gives you cause for concern, please let me know. I look forward to hearing from you by XXX and receiving your completed final report. If you have any questions, please do not hesitate to contact me. Page 5 of 6

6 APPENDIX 4 CONFIRMATION OF END OF RESEARCH STUDY Start : Completion : Our records show that your project - detailed above - finished on xxxx. Please can you confirm the exact completion date of the study, so that we can ensure our database is up-to-date and accurate. It would be helpful if you could this information, quoting the study number and title as shown above, via to brd@bath.ac.uk Many thanks for your help with this, should you have any questions please do not hesitate to contact me. Page 6 of 6