SOLICITATION NOTICE
Q -- Administrative & Technical Support Services
- Notice Date
- 7/21/2021 7:23:59 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- RPO EAST (36C24E) PITTSBURGH PA 15212 USA
- ZIP Code
- 15212
- Solicitation Number
- 36C24E21R0022
- Response Due
- 8/23/2021 7:00:00 AM
- Archive Date
- 10/22/2021
- Point of Contact
- Michael Haydo, Contracting Officer:, Phone: (412) 822-3158
- E-Mail Address
-
michael.haydo@va.gov
(michael.haydo@va.gov)
- Small Business Set-Aside
- SDVOSBC Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)
- Awardee
- null
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number 36C24E21R0022 is issued as a Request for Proposal (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-92. This requirement will be made using a cascading set-aside under the associated NAICS code 541611 Administrative Management and General Management Consulting Services with a small business size standard of $16.5 Million. The full solicitation document is included as an attachment to this notice; to include: a list of contract line items, a Description of requirements for the items to be acquired, SOW, Date(s) and place(s) of delivery, and applicable clauses and provisions. Evaluation procedures: Evaluation of offers will be made in accordance with FAR 13.106-2, and award made on the basis of Best Value. Evaluation Factors include the following: Technical Capability to include an assessment of Proposed Personnel (submission of resumes for Key Personnel is required), Technical Approach, and Corporate Experience and Management; Past Performance; and Price (to include a labor breakdown, work breakdown structure (WBS), and a price/cost realism analysis). Statement of Work Administrative and Technical Support Services Contract 1.0 BACKGROUND The Department of Veterans Affairs (VA) Office of Research and Development (ORD) oversees thousands of research projects in such research areas as aging, women s health, post-traumatic stress disorder, cancer, and genomics. A secondary benefit of these research endeavors is the transfer to the healthcare delivery system of new and beneficial technologies resulting from research conducted throughout the VA medical centers. ORD consists of four research services that together form a cohesive whole to explore all phases of Veterans' health care needs: Biomedical Laboratory Research & Development (BLRD); Clinical Science Research & Development (CSRD); Health Services Research & Development (HSRD) and Rehabilitation Research & Development (RRD). Additional Research Programs within ORD include the Quality Enhancement Research Initiative (QUERI), the Office of Research Protection, Policy and Education (ORPP&E), the Million Veteran Program (MVP), Technology Transfer Program (TTP) and the Cooperative Studies Program (CSP). The mission of the Office of Research Protections, Policy, and Education (ORPP&E) is to protect participants in VA human research. ORPP&E is responsible for: all policy development and guidance for human research protection in the VA; all training and education in human research protection throughout the VA; and oversight of the administrative operation of the VA Central Institutional Review Board (VA CIRB), which reviews and has oversight of designated VA multi-site and single site projects. ORPP&E's vision is to make VA human research as safe as possible. Additional information about ORPP&E can be found at https://www.research.va.gov/programs/orppe/default.cfm. The intended contract seeks to acquire technical and administrative support for the following functions: ORPP&E s regulatory policy team is responsible for developing policy and guidance for the 108 VA facilities engaged in human subject research. As part of this effort, ORPP&E maintains a total of five mailboxes and one database to manage the receipt of questions from VA facilities. In 2020, an estimated 800 questions were received in the various mailboxes ORPP&E manages. ORPP&E also manages five listservs to facilitate the sharing of information and best practices amongst VA facilities engaged in human subject research. ORPP&E s regulatory policy team is also responsible for managing VA s national implementation of the Cooperative Research Provision/Single IRB Requirement found in 38 CFR 16.114. Programmatic responsibilities include managing the process by which study teams request exceptions to the single IRB requirement and facilitating the process by which study team s obtain ORD approval to rely on ORD approved commercial IRBs for industry-sponsored multisite non-exempt research. A total of 200 single IRB exception requests and 153 applications to rely on a commercial IRB were processed in 2020. ORPP&E s education and training team is responsible for conducting training and education for the 108 VA facilities and their university affiliates that are engaged in human subject research. A total of 35 education and training sessions were offered in FY20 to over 12,343 attendees. The team is responsible for hosting both in-person and remote educational training sessions on issues pertaining to the conduct and oversight of research involving human subjects. The team is also responsible for the dissemination of guidance and tools to VA facilities involved in the conduct and oversight of VA research involving human subjects. The VA Innovation and Research Review System (VAIRRS) is the VA's enterprise instance of IRBNet. VAIRRS is the research committee software management platform for all VA medical centers with research programs and is uniquely positioned to withstand the changing pressures of research needs, including: oversight needs of the research programs and institutions collaborative needs of dually appointed VHA investigators regulatory changes of the new Common Rule (2019). As of November 2020, a total of 48 VA facilities have transitioned to the VAIRRS platform, with the remaining facilities scheduled to transition onto the platform by the end of FY21. The VAIRRS platform houses a library of over 60 forms and templates that are used by VA facilities in the conduct and oversight of research involving human subjects. The VA Central IRB has been in existence for over 12 years and is responsible for providing IRB oversight of human subject research for VA facilities nationwide. The VA CIRB currently has Memorandums of Understanding (MOUs) with 108 VA facilities for which it serves as an IRB of record. The VA CIRB is currently comprised of two IRB panels, with a third panel scheduled to begin operation in 2021. As of December 31, 2018, the two panels had oversight of 228 studies involving 1,490 local sites. In 2019, the VA Central IRB received 35 new studies and approximately 44 new protocol applications, which includes 199 associated LSI applications. With the implementation of the single IRB requirement in 2020, this number is expected to only increase. The two existing panels review, approve, and provide continuing oversight of human subject research for which more than one VA facility is engaged in human subjects research. The third panel will be responsible for reviewing single site human subjects research conducted at smaller VA facilities that do not have a primary IRB of record. 2.0 PURPOSE AND SCOPE The purpose of this contract is to obtain administrative and technical assistance in support of the Office of Research Protections, Policy, and Education. To support the tasks identified below requires an experienced and cohesive team of technical and administrative professionals who can demonstrate a comprehensive understanding of the regulatory and policy requirements governing the conduct and oversight of human subjects research and the infrastructure needed to support these activities for approximately 108 VA facilities nationwide. Support to ORPP&E s regulatory policy team shall include (1) providing administrative support to maintain the five mailboxes and FAQ database, to include updating the database with questions and responses received and (2) providing administrative support to track and process single IRB exception requests and applications to rely on commercial IRB s for multisite non-exempt research. Support to ORPP&E s education and training team includes providing administrative assistance with educational trainings to include assisting with pre-and post-event activities and assisting with the administration of webinars using platforms available to ORPP&E (e.g. gotowebinar, CISCO Webex, Microsoft Teams). Support to the VAIRRS team includes providing administrative support with the planning and hosting of meetings pertaining to the VAIRRS program and providing administrative support with managing the document review process for the creation and revision of templates and forms related to the VAIRRS program. Support to the VA CIRB will include providing both technical and administrative assistance in managing the receipt and processing of human subject research applications, to include new submissions as well as post-approval monitoring (i.e. amendments/modifications, continuing reviews, and reportable events). Additional duties of the Contractor shall include (1) providing meeting support to include scheduling panel meetings, ensuring distribution of meeting materials electronically to IRB panel members and staff, and preparing meeting agendas and minutes for VA CIRB panel meetings; (2) assisting in the preparation and review of Standard Operating Procedures and related forms for the VA CIRB; and (3) conducting annual file audits of a select number of VA CIRB study folders. 3.0 PLACE OF PERFORMANCE The contract services and activities will take place primarily at the VA ORD in Washington D.C. or at approved Contractor facilities mutually agreed to by the Contractor and the VA, to include the option of telework. 4.0 PERIOD OF PERFORMANCE The period of performance shall be one base period of twelve months and three option periods of twelve months each. Only the VA under authority of the VA Contracting Officer has the authority to exercise an option under this Agreement. 5.0 GENERAL REQUIREMENTS The Contractor shall contact the Contracting Officer and Contracting Officer Representative (COR) to set up a contract award kick-off meeting within the first 15 calendar days of the contract award date. The Contractor will provide a plan, the Project Management Plan (PMP) , as to how tasks will be successfully completed. The PMP shall include a narrative and graphic format displaying schedule, specifically defined milestones, risks, communications, and resource support. The PMP shall explain how the Contractor will coordinate and execute planned, routine, and ad hoc requirements as identified in the PWS. A list of staff assignments supporting each task shall be included once they are determined. The PMP will be submitted within 30 calendar days of contract award. Upon acceptance, the initial PMP will be considered baseline and shall be updated as needed. The Contractor will contact the COR to set up semi-annual evaluation meetings to discuss the status of the contract, deliverables, and contract performance. Prior to meeting, the VA COR will coordinate schedules for VA staff to receive input for the evaluation of the performance of the Contractor. The Contractor will prepare agendas and minutes for the semi-annual contract meetings. At the request of the VA COR, the Contractor shall take minutes of conference calls and/or meetings held with the Contractor management, VA COR, and Stakeholders. Copies of these minutes shall be provided to the COR. Hours of Operation: the hours of operation will be specified in the approved Project Management Plan. Travel: Travel is not anticipated under this contract. 6.0 SPECIFIC TASKS AND DELIVERABLES Contractor personnel shall provide all administrative and technical support for the tasks outlined below: Task 1: Administrative Helpdesk Support The Contractor shall provide administrative helpdesk support to ORPP&E. Deliverable 1.1 The Contractor shall have experience working with Microsoft Access Databases. The Contractor shall transfer questions and responses received from the five mailboxes managed by ORPP&E as well as questions and responses from newly published FAQs and guidance documents into the FAQ database monthly. Deliverable 1.2 The Contractor shall be responsible for maintaining ORPP&E mailboxes, to include organizing and collating questions and responses and purging redundant questions monthly. Deliverable 1.3 The Contractor shall add VA email addresses of individuals to the various listservs that ORPP&E manages (e.g. IRB Chairs, IRB Administrators, Training and Education, R&D Committee, and Small Research Programs) on an ongoing basis. Task 2: Meeting and Training Support: Education and Training The Contractor shall provide administrative support to ORPP&E s education and training program. Deliverable 2.1 The Contractor shall be responsible for scheduling and conducting tech walks with first time webinar presenters, to include all individuals granted open mics, prior to ORPP&E scheduled webinars. The Contractor shall send emails requesting availability for a tech walk a minimum of one week before the webinar to ensure tech walks occur for all presenters before the day of the scheduled webinar. Deliverable 2.2 The Contractor shall assist with administering/hosting webinars using the platform available to ORPP&E. Activities will include adding requisite information to the webinar platform, to include the title and duration of the webinar; speakers names, titles and email addresses; handouts, polls and surveys; opening the webinar platform at the designated time; managing questions received during the webinar to include displaying questions on the screen for viewers at the appropriate time; displaying presenter slides when necessary; and helping to resolve any issues that may come up during the course of the webinar. Deliverable 2.3 The Contractor shall assist with post webinar activities, to include preparing survey and data analytics generated from the webinar platform, to include attendee registration information, attendance records, questions submitted, response to post-webinar evaluation surveys and sending webinar recordings, associated handouts, presenter information, key words used to tag each webinar for search functionality, and transcripts to ORPP&E s webmaster for posting to the webpage. Task 3: Meeting and Training Support: VAIRRS Program The Contractor shall provide administrative support to the VAIRRS Program. Deliverable 3.1 The Contractor shall be responsible for scheduling project management and workgroup session meetings for the VAIRRS program. The Contractor shall maintain workgroup rosters and coordinate availability of workgroup members and meeting participants for workgroup and project management meetings, respectively. The Contractor shall coordinate availability of meeting participants and set up in-person and remote meetings using approved meeting platform. The Contractor shall solicit agenda topics from meeting participants; prepare and disseminate meeting agendas; attend meetings, track open tasks and action items; and prepare meeting minutes. Deliverable 3.2 The Contractor shall be responsible for scheduling monthly webinars, obtaining webinar materials from presenters and attending webinars and managing presentations as necessary. Deliverable 3.3 The Contractor shall be responsible for assisting with VAIRRS program communication efforts to include the following: Drafting monthly program updates for posting on the VAIRRS external webpage or the internal SharePoint site; monitoring and responding to questions received in the VAIRRS program mailbox; and elevating questions to the VAIRRS Program Manager as appropriate. Deliverable 3.4 The Contractor shall be responsible for drafting revisions to the VAIRRS library of forms and templates based on input received during document review sessions, tracking changes made to forms and templates, and maintaining a list of the most current versions of all forms. Task 4: VA Central IRB Support Protocol Review and Processing The Contractor shall support the VA CIRB by processing new study submissions and managing post-approval monitoring (amendments, continuing review, and reportable events) for all assigned human subjects research studies. The Contractor shall ensure that all documents produced by and in support of the VA CIRB are written clearly, concisely, and incorporate all required regulatory and VA policy requirements. Deliverable 4.1 The Contractor shall use the approved IRB platform for managing research studies (e.g. IRBNet and VA CIRB database). All protocol actions must be processed in accordance with VA CIRB SOPs. Deliverable 4.2 The Contractor manages both PI applications and Local Site Applications from all local participating sites for the assigned study (which can involve anywhere from 1 site to over 50 sites per study nationwide), notifying all sites of the requirement for local review, collecting all comments and summarizing them for review by the IRB, and highlighting any problems or concerns that may require additional required changes or modifications to the study for review by the IRB. Deliverable 4.3 The Contractor shall perform administrative and technical reviews of assigned study applications to identify missing or incomplete documentation and to highlight areas that may be deficient or require clarification. The contractor will complete required review forms and communicate findings to the study team and/or assigned IRB members as necessary. Deliverable 4.4 The Contractor shall coordinate review of the study submission among the study team and assigned IRB members to include information security, regulatory, privacy, and VA Central IRB voting primary, secondary, and informed consent reviewers, ensuring that all reviews are completed in a timely manner, summarizing comments, and contacting the study team to request additional information and/or changes to the project or forms. Deliverable 4.5 The Contractor shall maintain a complete file of all submitted study documents, results of all reviews by assigned reviewers, and all correspondence in accordance with VA CIRB SOPS and other regulatory requirements. The Contractor shall ensure strict document and version control to preserve the integrity of approved documents. Deliverable 4.6 The Contractor shall prepare interim and final letters to the study team for actions eligible for expedited review, notifying all relevant parties, including but not limited to the national study team, all local participating sites, local participating research offices, and coordinating centers, of the results of each review and the regulatory basis for requested changes, until the study team has satisfied all identified reviewer and regulatory concerns and a final approval letter from the IRB is issued. The Contractor is responsible for ensuring that all expedited actions are appropriately reported to the next convened meeting of the IRB. Deliverable 4.7 The Contractor shall ensure all databases and tracking logs are kept up to date, so the exact status of a given project is known at all times. Deliverable 4.8 The Contractor shall manage communication with, and provides advice and guidance to Principal Investigators, Study Chairs, and Study Teams, throughout all stages of the study, from application submission to conclusion of the study. Deliverable 4.9 The contractor shall manage all post-approval monitoring activities as assigned by VA Central IRB Management staff to include the processing of modifications to approved studies, continuing review or annual reports as required, and the processing of reportable event reports to include unanticipated problems, protocol deviation and violations, local RCO and other audit reports, and complaints. In managing these actions, the tasks delineating in deliverables 4.1 through 4.8 also apply. Task 5: VA Central IRB Support Meeting Support The Contractor shall provide pre-meeting, meeting, and post-meeting support to all panels of the VA CIRB. The Contractor shall ensure that all documents produced by and in support of the VA CIRB are written clearly, concisely, and incorporate all required regulatory and VA policy requirements. Deliverable 5.1 The Contractor shall assist with generating agendas for VA CIRB meetings, to include coordinating schedules with VA CIRB members to ensure both quorum and appropriate placement of items on the agenda with sufficient allocation of time to agenda items. Deliverable 5.2 The Contractor shall ensure that actions that require review by the convened IRB are placed on the appropriate meeting agenda for review and that all project documents are received from the study and available to IRB members for review. The Contractor is responsible for alerting the IRB Panel Manager if experts are needed for the review of the protocol and ensuring the study team s availability at the meeting when necessary. Deliverable 5.3 The Contractor shall attend IRB meetings where his/her assigned protocol will be reviewed and shall be responsible for taking accurate, detailed, and comprehensive notes during the meeting and drafting letters that accurately capture required changes and recommendations made by the convened IRB, ensuring that all letters are clear and reflect the regulatory basis for the actions and determinations by the IRB during the meeting. Deliverable 5.4 The Contractor shall provide support to the VA CIRB panel administrator during meetings by attending meetings, tracking attendance throughout the duration of the meeting, and taking detailed notes during the meeting. Deliverable 5.5 The Contractor shall prepare accurate, detailed, and complete meeting minutes of VA CIRB meetings, ensuring that meeting minutes are compliant with VA and other federal requirements as well as VA CIRB SOPs. The Contractor will assist with publishing final minutes to IRBNet and the VA CIRB SharePoint site as necessary. Task 6: VA Central IRB Support Administrative Support Deliverable 6.1 The Contractor shall assist with revising VA CIRB SOPs as requested by VA Central IRB management personnel. Deliverable 6.2 The Contractor shall assist with updating forms, checklists, templates, and reports used by the VA CIRB as requested by VA Central IRB Management personnel. Deliverable 6.3 The Contractor shall perform file audits of up to 20 VA CIRB Principal Investigator protocols on an annual basis. Protocols to be audited will be designated by VA Central IRB Management personnel. Deliverable 6.4 The Contractor shall assist with preparing for oversight inspections and site visits as necessary. Deliverable 6.5 In rotation with other VA CIRB staff, the Contractor shall be responsible for answering calls received on the national VA Central IRB toll free line, logging in the calls, and providing and appropriate response or forwarding the call to VA Central IRB staff if indicated. Task 7: Regulatory and Policy Support Implementation of the Cooperative Research Provision/Single IRB Requirement The contractor shall provide administrative support to ORPPE s cooperative research provision/single IRB program. Deliverable 7.1 The Contractor shall ensure that all checklists and other required documents for the Non-VA Institutional Review Board Application Process are included in the application process, entering applications into the tracking system, and routing documents appropriately to required reviewers. Deliverable 7.2 The Contractor shall maintain and track records of the status of IRB reliance agreements and Federal Wide Assurance (FWA) for non-VA Institutional Review Board including maintaining a database of when IRB reliance agreements are executed, modified, renewed, suspended, or terminated. Deliverable 7.3 The Contractor shall maintain a database of the status of Federal Wide Assurances for any non-VA IRB used by a VA Facility, including when it is executed with an Office of Research Oversight addendum, modified, suspended, or terminated. 6.1 DELIVERABLES TABLE TASK DELIVERABLE PLANNED COMPLETION DATE Task 1: Administrative Help Desk Support 1.1 The Contractor shall have experience working with Microsoft Access Databases. The Contractor shall transfer questions and responses received from the five mailboxes managed by ORPP&E as well as questions and responses from newly published FAQs and guidance documents into the FAQ database on a monthly basis. As outlined in task order. Task 1: Administrative Help Desk Support 1.2 The Contractor shall be responsible for maintaining ORPP&E mailboxes, to include organizing and collating questions and responses and purging redundant questions on a monthly basis. As outlined in task order. Task 1: Administrative Help Desk Support 1.3 The Contractor shall add VA email addresses of individuals to the various listservs that ORPP&E manages (e.g. IRB Chairs, IRB Administrators, Training and Education, R&D Committee, and Small Research Programs) on an ongoing basis. As outlined in task order. Task 2: Meeting and Training Support Education and Training Program 2.1 The Contractor shall be responsible for scheduling and conducting tech walks with first time webinar presenters, to include all individuals granted open mics, prior to ORPP&E scheduled webinars. As outlined in task order. Task 2: Meeting and Training Support Education and Training Program 2.2 The Contractor shall assist with administering/hosting webinars using the platform available to ORPP&E. As outlined in task order. Task 2: Meeting and Training Support Education and Training Program 2.3 The Contractor shall assist with post webinar activities. As outlined in task order. Task 3: Meeting and Training Support VAIRRS Program 3.1 The Contractor shall be responsible for scheduling project management and workgroup session meetings for the VAIRRS program. As outlined in task order. Task 3: Meeting and Training Support VAIRRS Program 3.2 The Contractor shall be responsible for scheduling monthly webinars, obtaining webinar materials from presenters and attending webinars and managing presentations as necessary. As outlined in task order. Task 3: Meeting and Training Support VAIRRS Program 3.3 The Contractor shall be responsible for assisting with VAIRRS program communication efforts. As outlined in task order. Task 3: Meeting and Training Support VAIRRS Program 3.4 The Contractor shall be responsible for drafting revisions to the VAIRRS library of forms and templates. As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.1 The Contractor shall use the approved IRB platform for processing research applications (e.g. IRBNet and VA CIRB database). All protocol actions must be processed in accordance with VA CIRB SOPs. As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.2 The Contractor manages both PI applications and Local Site Applications from all local participating sites for the assigned study As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.3 The Contractor shall perform administrative and technical reviews of assigned study applications. As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.4 The Contractor shall coordinate review of the study submission among the study team and assigned IRB members. As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.5 The Contractor shall maintain a complete file of all submitted study documents, results of all reviews by assigned reviewers, and all correspondence As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.6 The Contractor shall prepare interim and final letters to the study team for actions eligible for expedited review. As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.7 The Contractor shall ensure all databases and tracking logs are kept up to date. As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.8 The Contractor shall manage communication with, and provides advice and guidance to Principal Investigators, Study Chairs, and Study Teams. As outlined in task order. Task 4: VA CIRB Support Protocol Review and Processing 4.9 The contractor shall manage all post-approval monitoring activities as assigned by VA Central IRB Management staff. As outlined in task order. Task 5: VA CIRB Support Meeting Support 5.1 The Contractor shall assist with generating agendas for VA CIRB meetings. As outlined in task order. Task 5: VA CIRB Support Meeting Support 5.2 The Contractor shall ensure that actions that require review by the convened IRB are placed on the appropriate meeting agenda and reviewed by the convened IRB. As outlined in task order. Task 5: VA CIRB Support Meeting Support 5.3 The Contractor shall attend IRB meetings where his/her assigned protocol will be reviewed and shall be responsible for taking accurate, detailed, and comprehensive notes during the meeting and drafting letters. As outlined in task order. Task 5: VA CIRB Support Meeting Support 5.4 The Contractor shall provide support to the VA CIRB panel administrator during meetings. As outlined in task order. Task 5: VA CIRB Support Meeting Support 5.5 The Contractor shall prepare accurate, detailed, and complete meeting minutes of VA CIRB meetings As outlined in task order. Task 6: VA CIRB Support Administrative Support 6.1 The Contractor shall assist with revising VA CIRB SOPs as requested. As outlined in task order. Task 6: VA CIRB Support Administrative Support 6.2 The Contractor shall assist with updating forms, checklists, templates, and reports used by the VA CIRB as requested. As outlined in task order. Task 6: VA CIRB Support Administrative Support 6.3 The Contractor shall perform file audits of up to 20 VA CIRB Principal Investigator protocols on an annual basis. As outlined in task order. Task 6: VA CIRB Support Administrative Support 6.4 The Contractor shall assist with preparing for oversight inspections and site visits as necessary. As outlined in task order. Task 6: VA CIRB Support Administrative Support 6.5 In rotation with other VA CIRB staff, the Contractor shall be responsible for answering calls received on the national VA Central IRB toll free line, logging them in, and providing an appropriate response and forwarding the question or problem to another VA Central IRB staff member. As outlined in task order. Task 7: Regulatory and Policy Support Implementation of the Cooperative Research Provision/Single IRB Requirement 7.1 The Contractor shall ensure that all checklists and other required documents for the Non-VA Institutional Review Board Application Process are included in the application process. As outlined in task order. Task 7: Regulatory and Policy Support Implementation of the Cooperative Research Provision/Single IRB Requirement 7.2 The Contractor shall maintain and track records of the status of IRB reliance agreements and Federal Wide Assurance (FWA) for non-VA Institutional Review Board. As outlined in task order. Task 7: Regulatory and Policy Support Implementation of the Cooperative Research Provision/Single IRB Requirement 7.3 The Contractor shall maintain a database of the status of Federal Wide Assurances for any non-VA IRB used by a VA Facility As outlined in task order. Table 1: Task/Deliverable Summary Indicator/Task/Deliverable Performance Standard Min Level Review Method(s) Frequency The Contractor shall contact the Contracting Officer and COR to set up a contract award kick-off meeting within the first 15 calendar days of the contract award date The kick-off meeting was held within 15 days of award 100% 100% Inspection Once The Contractor shall provide project management support. A Project Management Plan (PMP) that lays out the Contractor s approach, timeline and tools shall be provided. A quality PMP is provided and updated annually. 95% Contractor-provided data Annually The Contractor shall contact the COR to set up semiannual evaluation meetings Semi-annual me...
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