LCRN Guidance Suite. V1.0 March Document Ref No: D05. Version 1.0 March 2016 Page 1 of 8

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1 LCRN Guidance Suite Provision of good practice for Sponsors to enable assesing, arranging and confirming local capacity and capability for participating organisations delivering CRN Portfolio studies V1.0 March 2016 Document Ref No: D05 Version 1.0 March 2016 Page 1 of 8

2 Document Control This document is issued and updated by the national Clinical Research Network (CRN) Coordinating Centre and forms part of the Local Clinical Research Network (LCRN) Guidance Suite a group of documents provided to support LCRN delivery against the CRN Performance and Operating Framework. Readers should ensure that the latest version is being viewed. Document Information Document Title Document Ref No. Principles of good practice for Sponsors to enable assessing, arranging and confirming local capacity and capability for participating organisations delivering CRN Portfolio studies D05 Version V1.0 Supersedes Function N/a Performance and Operating Framework: Section 6 Research Delivery Effective Date March 2016 Audience Sponsors, Researchers and Life Science Companies conducting NIHR CRN Portfolio studies. All LCRN partner organisations. Participating Organisation staff delivering NIHR CRN Portfolio studies. LCRN Staff. Category Expectation Purpose For guidance National standard with local flexibility The purpose of the document is provide guidance for the principles of good practice to enable Partner Organisations in assessing, arranging and confirming local capacity and capability to an agreed standard for NIHR CRN Portfolio studies. Version 1.0 March 2016 Page 2 of 8

3 Contents 1. Introduction 4 2. Principles of good practice to enable assessing, arranging and confirming local capacity for CRN Portfolio studies 4 3. Abbreviations & Glossary 7 4. Key Contact 8 5. Abbreviations 8 Version 1.0 March 2016 Page 3 of 8

4 1. Introduction HRA approval provides one approval for research studies for the NHS in England. It combines a single assessment of governance and legal compliance with the independent REC opinion (if required). For Participating Organisations, this provides the means to confidently assess, arrange and confirm local capacity and capability for their involvement in a study to Sponsors. While the Participating Organisation has overall responsibility for study set up (capacity and capability assessment) and confirmation of study participation, it requires provision of key information from the Sponsor following completion of HRA initial assessment following submission for HRA Approval. The CRN has therefore produced this document, in consultation with the HRA and the R&D Forum, to support Sponsors to enable the participating partner organisations consistently deliver their assessment, arrangement and confirmation of local capability and capacity activities for CRN studies in accordance with the framework outlined by HRA approval. 2. Principles of good practice to enable assessing, arranging and confirming local capacity and capability for CRN Portfolio studies. What is expected of Sponsors? 1. Early engagement with the CRN as outlined by the Study Support Service, prior to HRA submission, to support study planning (e.g. general resource signposting, understanding CRN portfolio eligibility, attribution review or costing template completion) and inform site identification where applicable (i.e. multiple site studies). 2. It is the responsibility of the Sponsor to provide the required information in a timely and reliable way to the Participating Organisation which enables assessment of capacity and capability to deliver the study and to put the necessary practical arrangements in place to comply with the protocol. This should be provided by a single sent to the following multiple recipients at a minimum: a. The contact address for the Participating Organisation as listed on the contact details for NHS Organisations on the NHS R&D Forum website. b. The Principal Investigator/local collaborator (or their nominated local coordinator), where known. c. The Local CRN generic address listed with each NHS organisation on the NHS R&D Forum website to enable provision of CRN support. 3. Sponsors who wish to set sites up in parallel to an application being reviewed for HRA Approval are recommended to send the document set to the Participating Organisation no more than 10 working days from the date of the HRA Initial Assessment letter. 4. Where the HRA Initial Assessment letter states that a Participating Organisation is required to assess, arrange and confirm local capacity and capability, the following document set and information must be provided to Participating Organisation. Version 1.0 March 2016 Page 4 of 8

5 a. A copy of the HRA Initial Assessment letter (or HRA Approval letter if site set up is post HRA Approval) b. The documents submitted as part of HRA Approval submission relevant to the site. c. A copy of the combined IRAS form. d. For commercial studies, the delegation log listing any known members of the local study delivery team. For non-commercial studies, the Statement of Activity and Schedule of Events for the Participating Organisation. Where the local study delivery team has not been identified or contacted previously, the Sponsor has the opportunity in the to list the proposed team, or to request help to locate the required information. e. A list of all above documents and their version numbers/dates which correspond to the versions submitted in the HRA Approval submission to clarify the documents provided. 5. The following information for the study is provided to Participating Organisation using the same distribution list once HRA Approval has been issued: a. A copy of the HRA Approval letter. b. The documents approved by the HRA as part of HRA Approval relevant to the site where different to those provided with the Initial Assessment letter (to minimise provision of duplicate versions). c. A copy of the combined IRAS form. d. A list of all above documents and their version numbers/dates for clarification of current versions 6. Where the sponsor wishes to include a new site after HRA Approval has been issued, and an amendment request has been submitted to the HRA, the following information for the study is provided to the new Participating Organisation using the distribution list described above: a. The current approved documents b. For commercial studies, the delegation log listing any known members of the local study delivery team. For non-commercial studies, the Statement of Activity and the Schedule of Events for the organisation. Where the local study delivery team has not been identified or contacted previously, the Sponsor has the opportunity in the to list the proposed team, or to request help to locate the required information. c. A copy of the combined IRAS form d. A copy of the HRA Approval letter and subsequent relevant amendment correspondence. e. A list of all above documents and their version numbers/dates for clarification of current versions. 7. Amendments are submitted to the HRA as per instructions on the HRA website. Following HRA categorisation of a study amendment requiring local review, the following information for the study is provided to the Participating Organisation using the same distribution list described above: a. The documents approved by the HRA as part of HRA Approval for the amendment relevant to the site. b. A copy of the amendment. c. A list of all above documents and their version numbers/dates for clarification of current versions. Version 1.0 March 2016 Page 5 of 8

6 Figure One: Flow of Information completes IRAS Form submits IRAS pack to HRA HRA issues outcome of initial assessment HRA issues HRA Approval to HRA Approval related activities includes Initial Assessment letter to local document set notifies site of HRA Approval Participating Organisation related activities identifies sites provides local document set to site and LCRN Arrangement capacity and capability Confirmation of capacity and capability Continuous Improvement The CRN will apply the continuous improvement process of Plan, Do, Study, Act. (PDSA) to maintain the effectiveness of this guidance. Please provide any feedback on this guidance to the Study Support Service Help Centre at Version 1.0 March 2016 Page 6 of 8

7 4. Key contact Laura Bousfield Study Start-Up Manager Fairbairn House Clarendon Road Leeds LS2 9PH Tel: Abbreviations Term CRN LCRN NIHR NHS HRA IRAS Participating Organisation PIC PDSA R&D REC Site Definition Clinical Research Network Local Clinical Research Network National Institute for Health Research National Health Service Health Research Authority Integrated Research Application System For the purpose of this document the term Participating Organisation is an organisation at a study level and includes an NHS organisation, General Practice, Tertiary Centre, Independent Provider, Any qualified Provider or Participant Identification Centre (PIC) as appropriate Participant Identification Centre Plan, Do, Study, Act Research & Development Research Ethics Committee The location which research activities are taking place for the study. Version 1.0 March 2016 Page 7 of 8

8 Fairbairn House Clarendon Road Leeds LS2 9PH Tel: Web.