Version: 2 21.1 17 STANDARD OPERATING PROCEDURE FOR STUDY REPORTING Health Research SOP TM10 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 J Rycroft Malone Director of R&D, BCUHB Pro-Vice Chancellor for Research, Date approved: 1.3.17 16.2.17 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 TM10 Version 2 21.1.17 Page 1 of 6
Bwrdd Iechyd Health Board Document History Version Effective Reason for change Number Date 1 14/02/14 New 2 20/03/17 Formatting header, Change of name pf R&D Director. Change reference to NISCHR. Minor typographical corrections. Summarised R&D progress reporting to R&D. Table of Contents 1. Flow Chart of Procedure... 3 2. Purpose... 4 3. Scope... 4 4. Responsibilities... 4 5. Procedures... 4 5.1 Research and Development reporting... 4 5.2 Research Ethics Committee reporting... 5 5.3 Clinical Research Portfolio Studies reporting... 5 5.4 Reports to funders... 5 6. Training... 6 7. Glossary... 6 8. Documents to be read alongside this procedure... 6 9. References and SOP Links... 6 Health Research SOP TM10 Version 2 21.1.17 Page 2 of 6
Bwrdd Iechyd Health Board 1. Flow Chart of Procedure Consider who requires reports when study is being conducted Regulatory bodies e.g. REC, R&D, Competent Authority (see SOP R05) Funder Sponsor UK CRN portfolio Determine what their reporting requirements are e.g. format, content, frequency Study accepted on Health and Care Research Wales Clinical research portfolio Agree who completes and approves reports and schedule for reporting UKCRN Accrual Upload system accessed through portal account Submit report in line with agreed schedules Upload recruitment activity onto the UKCRN database on a monthly basis Flow Chart Symbols Preparation Process Decision Terminator Document Health Research SOP TM10 Version 2 21.1.17 Page 3 of 6
Bwrdd Iechyd Health Board 2. Purpose This procedure outlines the reports that may be required when a study is being conducted and defines the system for reporting research activity and recruitment. This is to ensure all research activity is registered with BCUHB/BU research offices and progress reported to the relevant regulatory bodies. This will enable organisations to comply with regulatory requirements. 3. Scope This procedure applies to all health research where BCUHB and or are the sponsor or host studies. 4. Responsibilities Role Responsibilities Chief Investigator ensure the report(s) follows sponsors, funding body, and regulatory reporting requirements, agree the format and content of the report(s) based on the size and nature on the study, agree the reporting schedule, ensure the report(s) are reviewed by the relevant members of the study team, agree who completes and where required approves the reports, ensure progress reports are provided to all relevant parties upload recruitment activity on to UKCRN database on a monthly basis. Principle Investigator report to Chief Investigator on recruitment activity on an agreed regular basis, where required provide progress reports. 5. Procedures 5.1 Research Ethics Committee reporting Progress reports should be submitted to the REC which gave the favourable opinion (the main REC) 12 months after the date on which the favourable opinion was given. Annual Progress reports should be submitted thereafter until the end of the study. The progress report should be completed in line with the Health Research Authority (HRA) annual progress report form: http://www.hra.nhs.uk/resources/during-and-after-your-study/nhs-rec-annualprogress-report-forms/ Multi-site studies In the case of multi-site studies, you only need to send progress reports to the main REC, you do not need to send copies to other local RECs. Health Research SOP TM10 Version 2 21.1.17 Page 4 of 6
Bwrdd Iechyd Health Board The REC office will acknowledge receipt of all progress reports. The Chief Investigator may be invited to attend a meeting of the main REC or a subcommittee to discuss the progress of the research. Following receipt of the first progress report, the Chair of the main REC has the discretion to waive the requirement for further reports on receipt of a written request from the Chief Investigator. This might be appropriate where a study has completed recruitment and intervention but has a long period of follow-up with minimal participant involvement. 5.2 Research and Development reporting Details of all health research within BCUHB will be registered on a database in the BCUHB R&D office in order to provide a resource detailing current activity within the Health Board and track its progress. On a six monthly basis the CI, PI or designated member of the research team will be sent a progress report form from the BCUHB R&D office. Completion of the form requires information regarding the progress of the study including details of adherence to the approved research protocol and recruitment activity. The research team is required to keep the BCUHB R&D, the NHS REC committee and where required designated BU contact updated on the progress of the study. As part of reporting R&D should be kept informed of any significant findings or recommendations by an independent Data Monitoring Committee or equivalent body established for the study (see also SOP S02 Safety reporting). The R&D Office will send a reminder to the CI, PI or designated member when the progress report is due.. Failure to submit the report may result in suspension of the R&D approval for this study. 5.3 Reports to funders Reporting requirements for individual funders should be established when study funding is approved which should include reporting schedule. Adherence to these requirements is important in order that to ensure that contractual obligations are met. 5.4 Clinical Research Portfolio Studies reporting The timely upload of recruitment data for Health and Care Research Wales Clinical Research Portfolio studies has several benefits. It allows: - NHS R&D Offices to actively manage studies and in particular identify those that are not on target to deliver, hence enabling steps to be taken to assist with delivery to time and target - Reporting to Health and Care Research Wales to ensure the funding stream is maintained. - Funding to be allocated to NHS organisations which best reflects the resources required for their participation levels in research. Health Research SOP TM10 Version 2 21.1.17 Page 5 of 6
Bwrdd Iechyd Health Board The data sources used for the NHS R&D allocations formula are the Health and Care Reseach Wales Clinical Research Portfolio (used to identify studies), and the UKCRN Portfolio data (used to identify recruitment to studies). For current reporting requirements visit the Health and Care Research web sitehttp://www.wales.nhs.uk/sites3/home.cfm?orgid=952 6. Training Training activities will be in accordance with training SOPs T01 Research Quality System Training and T02 Trial Specific Training. 7. Glossary BCUHB BU CI Ethical approval HRA IRP REC SOP Sponsor UKCRN Health Board Chief Investigator the requirement to gain approval of your project from the Research Ethics Committee Health Research Authority Internal Review Panel Research Ethics Committee. Standard Operating Procedure Person or organisation taking ultimate responsibility for the project. United Kingdom Clinical Research Network 8. Documents to be read alongside this procedure SOP T01 Research Quality System Training SOP S02 Safety reporting in research. SOP B03 Honorary Research contract and access to patient data SOP R04 NHS Approvals SOP R05 MHRA approval SOP TM09 Study closure and follow-up SOP TM11 End of study reporting 9. References and SOP Links Clinical Trials Directive 2001/20/EC Good Clinical practice Directive 2005/28/EC Medicines for Human Use (Clinical Trials) Regulations 2004 Medicines for Human Use (Clinical Trials) Amendment Regulations (2006) Research Governance Framework for Health and Social Care in Wales 2 nd Edition (2009) Health Research SOP TM10 Version 2 21.1.17 Page 6 of 6