NIH StrokeNet Network Standard Operating Procedure

Transcription

1 1. PURPOSE The purpose of this SOP is to outline procedures for Institutional Review Board (IRB) approval and oversight of National Institutes of Health (NIH) StrokeNet affiliated protocols conducted by Department of Veterans Affairs (VA) Facilities. The VA Central IRB (VA CIRB) will serve as the IRB of Record for VA Facilities conducting NIH StrokeNet affiliated protocols. The VA CIRB will collaborate with the National Coordinating Center (NCC), the National Data Management Center (NDMC), and the StrokeNet Central Institutional Review Board (StrokeNet CIRB). 2. DEFINITIONS AND ACRONYMS National Coordinating Center (NCC) -An institution designed and directly funded by NINDS/NIH to oversee project management for NIH StrokeNet research protocols. The NCC for NIH StrokeNet is located at the University of Cincinnati. NCC Project Manager - The individual responsible for being the interface with StrokeNet CIRB liaison, the VA Protocol Principal Investigator (VA PPI), and VA Local Site Investigators (LSI) for all-va Facilities participating in a specific StrokeNet protocol. This includes approvals and modifications of new protocols, protocol modifications, local site submissions, continuing reviews, and reporting of unanticipated problems involving risks to subjects or others, SAEs, and protocol deviations. National Data Management Center (NDMC) - An institution designed and directly funded by NINDS/NIH to oversee all aspects of data collection and management for NIH StrokeNet research protocols. The NDMC for NIH StrokeNet is located at the Medical University of South Carolina (MUSC), Charleston, NC. National Institutes of Health (NIH) StrokeNet - The National Institute of Neurological Disorders and Stroke (NINDS) established the NIH StrokeNet to facilitate the rapid initiation and efficient implementation of small and large multisite exploratory and confirmatory clinical trials focused on promising interventions for stroke prevention, treatment, and recovery, as well as validation studies of biomarkers or outcome measures. The main components include the National Coordinating Center (NCC) at the University of Cincinnati, the National Data Management Center (NDMC) at the Medical University of South Carolina, and 25 academic regional coordinating centers (RCCs) across the United States. NIH StrokeNet Central Institutional Review Board (StrokeNet CIRB) - An IRB designed and directly funded by NINDS/NIH to oversee human subject research for NIH StrokeNet research protocols. The StrokeNet CIRB serves as the IRB of Record for non-va sites. The StrokeNet CIRB is operated and managed at the ADM 23 Final v1.0 Page 1 of 8

2 University of Cincinnati and will provide IRB oversight for all non-exempt human subject research activities for non-va sites. Protocol Principal Investigator (PPI) - The investigator at the prime award site who was awarded funding for the execution of the NIH StrokeNet research protocol. The PPI is responsible for the development of the prime award protocol and the coordination of the conduct of the research at multiple performance sites, including required regulatory reporting to the VA CIRB through the VA investigators. For purposes of StrokeNet, the PPI is also considered the sponsor for all FDA and DSMB activities. If this person is the IND or IDE holder, this individual is also responsible for all applicable FDA regulatory requirements, which includes all Sponsor-Investigator responsibilities. The PPI may be from a VA or non-va institution. Performance site - A site at which the prime award protocol is performed. Prime Award Site - The institution that is awarded the grant to oversee the study protocol Prime Award Protocol - Protocol for the multi-site clinical trial submitted by the PPI that is initially approved by the StrokeNet CIRB and VA CIRB. (SOP) - established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations. StrokeNet CIRB Liaison - The StrokeNet CIRB Liaison coordinates communications between the StrokeNet CIRB and StrokeNet research sites. StrokeNet /VA Site Coordination Team - The Chairs of the VA CIRB and the StrokeNet CIRB as well as the VA CIRB administrator, StrokeNet CIRB Liaison, and the NCC Project Manager VA Central Office Institutional Review Board (VA CIRB) - The central IRB supported by the VHA Office of Research and Development that has authority for oversight of VA human subjects studies it approves. VA CIRB Administrator -The VA CIRB Administrator is responsible for overseeing the daily administrative activities of the VA CIRB. VA Office of Research and Development (ORD) - is the office within VHA that is has primary responsibility for developing the policies involving the conduct of research at VA Facilities as well being ADM 23 Final v1.0 Page 2 of 8

3 responsible for the intramural VA research program. ORD consists of the following four research services: Biomedical Laboratory Research & Development Service Clinical Science Research & Development Service, which includes the Cooperative Studies Program (CSP) Health Services Research & Development Service Rehabilitation Research & Development Service ORD also include different program offices that support VA research. This includes the Program for Research Integrity, Development, and Education (PRIDE), which is responsible for the operation of the VA CIRB VA-Local Site Investigator (LSI) - The Local Site Investigator (LSI) is a VA qualified investigator at a site participating in a multi-site research project. The LSI oversees scientific, technical, and day-to-day management of the research at the performance site. The VA Protocol Principal Investigator is not analogous to a LSI, but a LSI can also be the VA Protocol Principal Investigator for a StrokeNet protocol. The LSI responsibilities are described in VHA Handbook and in VA Central IRB SOPs. The VA Central IRB SOPs are available for reference on the VA Central IRB website VA Protocol Principal Investigator (VA PPI) - A VA Investigator designated as the overall PI for all VA Facilities participating in a specific StrokeNet protocol. The VA PPI is not analogous to a LSI. The VA PPI and the National Study Coordinator serve as the main points of contact on the study team for the VA CIRB regarding activities involving the overall project. The PPI responsibilities are described in VHA Handbook and in VA Central IRB SOPs. The VA Central IRB SOPs are available for reference on the VA Central IRB website WebDCU - An integrated web-based clinical trial management system (CTMS) developed by NDMC for clinical trial data management and full scope trial operation management. ADM 23 Final v1.0 Page 3 of 8

4 3. SCOPE The VA CIRB and StrokeNet CIRB are two central IRBs. The VA CIRB is part of the VHA Central Office Human Research Protection Program (HRPP) in Washington, DC. The StrokeNet CIRB is part of the HRPP at the University of Cincinnati in Cincinnati, OH. The VA CIRB is the IRB of Record for all VA Facilities conducting StrokeNet studies, including the Cincinnati VA. The StrokeNet CIRB is the IRB of Record for all non-va Facilities conducting StrokeNet studies. This SOP applies to the coordination of activities that involves obtaining VA CIRB review and approval of StrokeNet studies conducted by VA Facilities in conjunction with the StrokeNet CIRB review and approval of StrokeNet studies conducted by non-va Facilities. 4. Roles of StrokeNet NCC and NDMC A. Role of the NCC 1. Establishing a VA PI for NIH StrokeNet Trials conducted at VA facilities All StrokeNet research projects involve a prime award protocol that is submitted by the PPI. The prime award protocol is approved for conduct at multiple performance sites. If VA Facilities are included as performance sites in a StrokeNet research project, a VA PI must be designated as a VA PPI prior to preparing application submission materials to the VA CIRB and designating VA LSIs. If the PPI is not a VA Investigator, the NCC will assist the PPI in identifying and establishing a VA Investigator as the VA PPI for the study. This individual will serve as a co-ppi. If the PPI is a VA Investigator, a PPI will also be designated for the non-va Facilities prior to preparing application submission materials to the StrokeNet CIRB and designating non-va participating LSIs. This individual will serve as a co-ppi. 2. Assist VA PI with preparing a New Project Application to the VA CIRB The NCC project manager will assist the VA PPI in completing VA CIRB forms and documents. The VA PPI will submit the required forms and associated documents to the VA CIRB per VA CIRB procedures to the VA CIRB SharePoint site. 3. Assist with submission of Local Site Investigator (LSI) Applications ADM 23 Final v1.0 Page 4 of 8

5 The NCC project manager will review and assist the VA LSI to complete VA CIRB forms and documents. The LSI will submit the completed forms to the VA PPI for review prior to upload to the VA CIRB SharePoint site. The VA PPI will not be responsible for submitting VA LSI applications to the VA CIRB; the LSI is responsible for uploading LSI applications. 4. Assist with submission of requests to amend or modify an approved project The NCC project manager will assist the VA PPI or LSI to complete the VA CIRB forms and documents. The VA PPI or LSI will upload the completed forms to the VA CIRB SharePoint site depending upon whether the amendment or modification involves the prime award protocol or modifications/amendments to the local conduct of the project (i.e., modification to an informed consent document involving changes to the local research team s contact information). 5. Assist with submission of Continuing Reviews The NCC project manager will assist the LSI or the LS study coordinator to complete VA CIRB Continuing Review Form prior to review and submission of the materials by the VA PPI. The VA PPI is responsible for submitting continuing review applications from all participating LSIs as well as completing an overall continuing review submission for the study. 6. Assist with Reporting of Serious Adverse Events and Unanticipated Problems The NCC project manager will assist the VA PPI in collecting data from the sites; reporting serious adverse events and unanticipated problems involving risks to subjects or others that require reporting to the VA CIRB in accordance with VHA Handbook and VA Central IRB SOPs. B. Role of the NDMC The NDMC is responsible for providing the WebDCU CTMS for all NIH StrokeNet trials. This system houses and manages the necessary regulatory documents collected for the trial execution and houses the trial data entered by each site participating in the trial. This system also tracks all protocol required, site reported adverse events and unanticipated problems. All VA Facilities participating in StrokeNet studies must sign a data use agreement (DUA) with NDMC describing the data being sent to and received from the NDMC as part of StrokeNet activities (see attachment B). The DUA is executed by the VA Facility authorized signatory (either the authorized Medical Center Director or the authorized Associate Chief of Staff for Research & Development). This ADM 23 Final v1.0 Page 5 of 8

6 document should be printed, signed by the appropriate VA Facility authorized signatory, and uploaded into the WebDCU Regulatory Document Module. This document will apply for all StrokeNet studies conducted at the facility and will be archived in the StrokeNet CTMS. 5. Coordinated CIRB Review of Prime Award Procedure A. For StrokeNet Studies in which VA Facilities are identified prior to the initial IRB approval of the prime award protocol: Prior to review of the prime award protocol by each respective CIRB, the StrokeNet/VA Site Coordination Team will conduct a pre-review of the submitted materials and communicate in writing or orally issues that could affect CIRB review and approval. This pre-review is not to be interpreted as an expedited IRB review process as described in 45 CFR (b) and 38 CFR (b) and does not take the place of IRB review procedures required for IRB approval of research. Following resolution of any issues identified by the StrokeNet/VA Site Coordination Team review, the StrokeNet IRB application materials will be submitted, if possible, within the same week for VA facilities and non-va Facilities to the VA CIRB and the StrokeNet CIRB. The VA CIRB and StrokeNet CIRB Chairs, the VA CIRB administrator, and the StrokeNet CIRB liaison will communicate during this process to discuss any significant discrepancies between the IRB reviews. 6. For StrokeNet Studies in which VA Facilities are identified after the StrokeNet CIRB approval of the prime award protocol: If VA facilities are identified as research sites after the StrokeNet CIRB approves the prime award protocol, the VA CIRB will review the prime award protocol most recently approved by the StrokeNet CIRB. The VA PPI will submit the protocol to the VA CIRB by the VA PPI. The VA CIRB must approve the protocol before it reviews and approves the VA LSI applications. If the VA CIRB identifies issues during the review that affect the approval process, the VA CIRB Chairs may communicate those issues with the StrokeNet CIRB Chair. 7. For StrokeNet Studies in which non-va Facilities are identified after the VA CIRB approval of the prime award protocol: If non-va facilities are identified as research sites after the VA CIRB approves the prime award protocol, the StrokeNet CIRB will review the prime award protocol most recently approved by the VA CIRB as submitted by the VA PPI. If the StrokeNet CIRB identifies issues during the review that affect the approval process, the StrokeNet CIRB Chair may communicate those issues with the VA CIRB Chairs. ADM 23 Final v1.0 Page 6 of 8

7 8. APPLICABLE REGULATIONS AND GUIDELINES 21 CFR Part 50, Protection of Human Subjects 21 CFR Part 56, IRBs 38 CFR Part 16, Protection of Human Subjects Final NIH Policy on the Use of a Single Institutional Review Board for Multi Site Research VHA Handbook (Research Compliance Reporting Requirements issued June 15, 2015) VHA Handbook (Requirements for the Protection of Human Subjects in Research issued November 12, 2014) 9. REFERENCES TO OTHER APPLICABLE SOPS VA CIRB SOPs are available at StrokeNet CIRB SOPs are available at ATTACHMENTS A. Memorandum of Understanding (MOU) between Veterans Health Administration and University of Cincinnati on behalf of Its Institutional Review Board B. Research Data Use Agreement Template between VA facilities and the NDMC ADM 23 Final v1.0 Page 7 of 8

8 11. DOCUMENT HISTORY Version Description of Modification Completion Date Issue Date Effective Date 1.0 FINAL 30-Nov Jan Jan-2017 ADM 23 Final v1.0 Page 8 of 8