Document Title: Research Database Application (ReDA)

Transcription

1 Document Title: Research Database Application (ReDA) Document Number: SOP035 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration Manager, Research Officers R&D Administration Manager Research and Development Research and Development NHS Staff Trust-Wide Review due: April 2018 THIS IS A CONTROLLED DOCUMENT Whilst this document may be printed, the electronic version maintained on the Trust s Intranet is the controlled copy. Any printed copies of this document are not controlled. Papworth Hospital NHS Foundation Trust. Not to be reproduced without written permission. Key Points of this Document This document sets out the procedures to be followed by all Papworth Staff who are involved in the receipt and management of research study related information and documentation, and the research governance process. It aims to provide clear guidance on what needs to be recorded within the Papworth Research and Development s Research Governance Database, called Research Database Application (ReDA) to ensure compliance with both Papworth R&D s, and the Trust s, policies. Instructions for how to use ReDA can be found in the user guide. Version 5.0 Review Date: April 2018 Page 1 of 10

2 1 Purpose and Content a. This document defines the Trust s procedures for the recording of research study related information and documentation in the Research Database Application (ReDA). b. The document aims to provide clear guidance on what research specific documentation and information should be recorded and stored so as to comply with the Trust s policies on Information Governance and Patient confidentiality. c. The monitoring of study documents and files to ensure the proper conduct of the study is outside the scope of this SOP and is described in SOP016: Monitoring. 2 Roles & Responsibilities a. This Policy applies to all personnel that are conducting research at the Trust including: staff that are full or part-time employees of the Trust, those working at the Trust with employment contracts funded partially or wholly by third parties including those within CUHP AHSC and those seconded to and providing consultancy to the Trust, and to students undertaking training at the Trust. b. Staff involved in the management and recording of the documentation used in research studies must comply with the requirements set out in section 4. The maintenance of accurate and up-to-date information is essential for the generation of accurate reports reflecting research study activity being undertaken at Papworth Hospital NHS Foundation Trust. c. The Research Governance Team are responsible for the timely creation of records, upload of documentation and entry of research study related information onto ReDA. d. The study team are responsible for notifying the Research Governance Team of new studies, amendments, the local end date, post approval change in status and other changes that could affect the conduct of the study. 3 Policy a. This SOP is mandatory and, as per the Trust s Information Governance and Records Management framework, non-compliance with may result in disciplinary procedures. Version 5.0 Review Date: April 2018 Page 2 of 10

3 4 Procedure a. ReDA is used to capture research study information; store documents; track a study s status; store CV s; GCP certificates; Letters of Access and Honorary Research Contracts and to record key dates. 4.1 Creation of a new project record in ReDA: a. A new project record is created for each research study prior to its inclusion on a RGPAS agenda. b. When the new research study record is created the next sequential number will be assigned with a P0 prefix, for example P c. A new project record is created for each service evaluation or research study not requiring ethical approval prior to issue of trust approval letter. d. When the new service evaluation or research study not requiring ethical approval record is created the next sequential number will be assigned with a S0 prefix, for example S Study Status a. The status of each research study must be updated as appropriate throughout its lifecycle. The following statuses are used: b. Status Definition New Study Research study undergoing feasibility prior to trust approval NTSTD (not started) Active Closed in follow up Complete Suspended Withdrawn Abandoned Service Evaluation Research study will not progress to trust approval Research study which is actively recruiting Research study ongoing, but recruitment complete Research study has concluded at Papworth Hospital Recruitment has halted but may resume Recruitment stopped prematurely and permanently by Sponsor Recruitment stopped prematurely and permanently by Papworth Hospital Service Evaluation or research study not requiring ethical approval Version 5.0 Review Date: April 2018 Page 3 of 10

4 b. Minimum information to be captured for a research study. The minimum information that is captured for each research study record is shown in appendix 1. c. Information will be entered as it becomes available during study set-up. d. A check for completeness will be conducted at trust approval. 4.3 Dates to be captured for a research study a. The key dates to be captured for each research study record are shown in Appendix2. b. Dates will be entered as they become available throughout the life of the study. 4.4 Documentation to be stored Non - portfolio studies: a. As new documents relevant to the study become available, these will be uploaded onto ReDA. b. The Trust Approval letter must be uploaded following Trust Approval Portfolio studies: a. For portfolio studies, full documentation is maintained on the NIHR s Research & Development Management Information System, CSP module. Documentation will not be duplicated on ReDA. b. The following statement must be added to the comments box: This is a portfolio study and as such full documentation will be available via the CSP module only. c. The Trust Approval letter must be uploaded following Trust Approval Project Reminders: a. A project reminder may be set for the date that monitoring needs to be performed on Papworth Sponsored studies. Monitoring intervals will be decided on a risk-based system as described in SOP016: Monitoring Papworth Sponsored Studies Version 5.0 Review Date: April 2018 Page 4 of 10

5 4.5 Substantial Protocol Amendments - (see Substantial Protocol Amendments SOP 037) Non portfolio- studies: a. Documents relevant to the protocol amendment will be uploaded onto ReDA. b. The Amendment Approval / Acknowledgement letter must be uploaded following Amendment Approval Portfolio studies: a. For portfolio studies, full amendment documentation is maintained on the NIHR s Research & Development Management Information System, CSP module. Documentation will not be duplicated on ReDA. b. The Amendment Approval / Acknowledgement letter must be uploaded following Amendment Approval. 4.6 Creation of a new contact in ReDA. a. A record is created for each Chief Investigator, Principal investigator, researcher and visiting researcher. b. Data and Records to be captured for each contact is shown in appendix 3. c. ReDA will be used to trigger reminders for renewal of expiring certification, Letters of Access or Honorary Contracts. 4.7 Other changes a. ReDA must be kept up-to-date with general changes in the study that do not require ethical approval e.g. new research team members, additional course dates etc. 5 Risk Management / Liability / Monitoring & Audit a. The R&D SOP Committee will ensure that this SOP and any future changes to this document are adequately disseminated. b. The R&D Department will monitor adherence to this SOP via the routine audit and monitoring of individual clinical trials and the Trust s auditors will monitor this SOP as part of their audit of Research Governance. From time to time, the SOP may also be inspected Version 5.0 Review Date: April 2018 Page 5 of 10

6 by external regulatory agencies (e.g. Care Quality Commission, Medicines and Healthcare Regulatory Agency). c. In exceptional circumstances it might be necessary to deviate from this SOP for which written approval of the Senior R&D Manager should be gained before any action is taken. SOP deviations should be recorded including details of alternative procedures followed and filed in the Investigator and Sponsor Master File. d. The Research and Development Directorate is responsible for the ratification of this procedure. Version 5.0 Review Date: April 2018 Page 6 of 10

7 Appendix 1 Minimum Information to be captured for Portfolio and Non portfolio research study records R&D Lead Short Title Full Research Title Chief Investigator Principal Investigator Sponsor Funder Ethics Reference Number Portfolio Status UK CRN ID (portfolio studies only) ISRCTN number (if applicable) CTA (Eudract number) if applicable If Papworth is Lead Centre If the study is a clinical trial If the research study is multicentre If the research study is interventional If the research study is a medicinal trial If the research study has trust approval If study recruitment has completed If the study is a commercial trial Stakeholders Has the first patient been recruited? Funders Target recruitment as documented in the trial agreement (if applicable) Version 5.0 Review Date: April 2018 Page 7 of 10

8 Appendix 2 Dates to be captured for a research study RGPAS Date Ethics Approval Date Trust Approval Date Local End Date Date of Valid Research Application (VRA) * Target date for completion of recruitment Date of first patient recruited Date of last patient recruited Total number of patients recruited to the study See SOP034 Trust Approval and Research Governance for definition of a Valid Research Application. Version 5.0 Review Date: April 2018 Page 8 of 10

9 Appendix 3 Information and Records to be captured for a contact Title and contact details CV GCP certificate Honorary research contract or Letter of Access issued Research Passport or NHS confirmation of pre-engagement checks Chief Investigator Principal Investigator Researchers Visiting Researchers Version 5.0 Review Date: April 2018 Page 9 of 10

10 Further Document Information Approved by: Management/Clinical Directorate Group Approval date: (this version) Ratified by Board of Directors/ Committee of the Board of Directors: Date: This document supports: Standards and legislation Key related documents: Research and Development Directorate 15 th April 2015 STET N/A Medicines for Human Use (Clinical Trials) Regulations 2004 and all associated amendments. Research Governance Framework for Health and Social Care (2005) Trust Research Policy Research and Development Standard Operating Procedures entitled: SOP011 Archiving SOP016 Monitoring Papworth Sponsored Studies SOP021 Trial closure and end of trial reporting SOP037 Substantial Protocol Amendments Trust Policy DN48 Case Note Retention & Disposal of Patient Records Equality Impact Assessment: Does this document impact on any of the following groups? If YES, state positive or negative, complete Equality Impact Assessment Form available in Disability Equality Scheme document DN192 and attach. Groups Disability Race Gender Age Sexual orientation Religious & belief Other Yes/No No No No No No No No Positive/Negative Review date: April 2018 Version Control Version Date effective Valid to Approved by Date of approval th Sept 2009 Sept 2009 RDD 4 th Sept th Dec 2009 Dec 2011 RDD 11 th Dec th Sept 2010 Sept 2012 RDD 10 th Sept st Aug 2012 June 2014 RDD 13 th July th May 2015 April 2018 RDD 8 th May 2015 Version 5.0 Review Date: April 2018 Page 10 of 10