SPECIAL NOTICE
A -- Research Protocol Management System
- Notice Date
- 11/18/2019 11:44:31 AM
- Notice Type
- Special Notice
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- RPO EAST (36C24E) PITTSBURGH PA 15212 USA
- ZIP Code
- 15212
- Solicitation Number
- 36C24E20Q0025
- Archive Date
- 12/18/2019
- Point of Contact
- Contracting Officer: Michael HaydoEmail: michael.haydo@va.gov
- E-Mail Address
-
michael.haydo@va.gov
(michael.haydo@va.gov)
- Awardee
- null
- Description
- The Veteran s Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with BEC Acquisition Co. based in Melville, NY. on behalf of the VA Bronx Healthcare System. The requirement is to provide a web-based protocol management system that provides for online submission and tracking of VA research protocols for current and planned VA medical studies. The Contractor shall provide and manage the infrastructure that houses research protocol data. System will provide at least six separate research committees/boards with the tools necessary to support the management, submission, review and oversight of all research protocols submitted to the JJP VAMC Research Service.Contractor shall provide a web-based research protocol management system that will provide electronic document management and web-based protocol sharing of electronic protocol submissions and reviews. Submission process shall include the ability to electronically sign documents which will be in compliance with CFR Title 21. System to allow for utilization of Customers current forms and workflows and will provide the following:Unlimited usage and accessibility via World Wide Web.Hosting web interface: 24-hr security, long-term storage, automated backups, multiple fiber carriers, more than one power grid, FIPS 140.2 compliant and 508 compliant.Access for an unlimited number of users.User accounts shall be password protected.Facilitates self-registration with approval by VA. Access to protocol information to be limited to study personnel, research administrative staff, committee reviewers/members and research compliance officer with access control regulated by VA.Full review of research protocols required by the following review boards:Research & Development Committee (R&DC)Institutional Review Board (IRB)Sub Committee for Research Safety (SRS) Financial Conflict of Interest (FCOI)Institutional Animal Care & Use Committee (IACUC)Institutional Biosafety Committee (IBC)Tracking of JJP research protocols submitted and approved by VA Central IRB shall allow for upload of protocol, approved letters, and other relevant correspondence for the Central Institutional Review Board (CIRB)Tracking of JJP research protocols submitted and approved by NCI Central IRB shall allow for upload of protocol, approved letters, and other relevant correspondence for the NCI Central Institutional Review Board (CIRB)Ability to add review committees as changing needs require.Unlimited smart form wizards for committees that are designed and implemented internally by JJP VAMC Research Service. Wizards shall include VA defined fields with questions that are dynamic in nature and shall direct the user to subsequent questions or additional forms based on the information provided. Questions shall not be repeated throughout any of the wizards. Information compiled from the combination of wizards shall be organized and documented in a clear and concise manner that enables reviewers and committee members to easily interpret the information provided. Reports based on these form wizards shall be accessible by Research Service Administration Staff and have the capability to be queried by or restricted to specific date intervals, investigators, project types, performance locations, or other relevant attributes as determined by said staff.Request to Review Research Proposal WizardShall assign Protocol number for all new research proposals, this number will be utilized by all committees for the life of the protocol.Shall include basic protocol information to include, study title, study staff, type of research being conducted, funding source, funding administrator, and performance sites. Questions shall gather basic information about the research staff and their responsibilities so as to determine the additional training and/or credentialing that may be required. Wizard shall be able to identify any and all subcommittees for which approval is required and direct the user on how to access appropriate wizard or upload other committee approvals. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process.Application for Initial IRB Review WizardShall not repeat any questions already asked as part of the Request to Review Research Proposal Wizard. Shall request information regarding subject population, risk assessment, informed consent, research procedures, investigational drugs and/or devices, and conflict of interest. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process.Application for Basic Science Study WizardShall not repeat any questions already asked as part of the Request to Review Research Proposal Wizard and if applicable, as part of the IRB Review Wizard. Shall request information regarding the use of wet lab space, human cell or tissue samples, shipping of biological hazards, microbial agents, recombinant DNA, animals, chemicals, chemical inventories, controlled substances, ionizing radiation, non-ionizing radiation, and physical hazards. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process.VA Data Privacy and Security Plan WizardWizard shall identify the types of VA research information being collected to include specific questions regarding how, where, and in what format the information will be stored. Questions shall determine if information is being shared outside of the VA and if so, how is it being transferred and secured, the type of organization to which it is being transferred, and whether it is proposed that any PII or PHI be transferred. Based on answers, smart form shall determine the need for a data use agreement and direct user to a template appropriate for the nature of the data to be transferred and the type of organization that is proposed to receive the data. Wizard shall have the ability to generate a research data inventory report identifying VA research data and its location, in accordance with VHA requirements.System shall include an online forms and documents library that is accessible to Users and is maintained and easily updated by Customer without requiring technical support from Contractor. Protocol submissions shall have the ability to be routed automatically through the online system for appropriate review and/or action by all required parties to include project staff, research admin staff, committee reviewers/members, Privacy & Information Security Officers, other component reviewers and Committee chairs. Routing mechanism shall allow simultaneous access to protocol submissions by multiple individuals, allow Customer to determine the sequence of access of individual parties or groups of individuals to the protocol submission, and allow Customer to notify individual parties when a protocol submission is available for their review and/or action.Electronic stamping capability for approved consent forms should be in compliance with VA and OHRP guidelines. Automatic email notifications with customizable text, identification of recipients, and at timelines specified by the Customer for the following: Upcoming expirations for continuing reviews, for IRB, SRS, IACUC, IBC, FCOI and R&DC Committees.Expiration of personnel qualifications, training, appointment status and scopes of practice. System shall provide details of protocol status at any given time to all affected users. As protocol moves through different steps in the review process, email notification shall be made to the Principal Investigator and to other members of the research team as specified by the Principal Investigator. Tracks all committee membership rosters with dates of expiration of committee appointment and of all relevant training and provides automatic email notices to committee members and committee chair with notice of upcoming expirations.Data tracked for all research staff shall include the following:NameCredentials (up to four)Option to capture three email addressesStudy RoleVA appointment type with expiration dateScope of practice with expiration dateAll training records to be linked to research staff and include expiration dates.Direct retrieval of training records from the Collaborative Institutional Training Initiative (CITI) and the VA Talent Management System (TMS). Auditing tools shall be an integral part of the system, identifying edits and reviews of all documents and shall include date/time of any changes as well as identifying the person making the change. The System shall provide for automatic generation of agendas for IRB, SRS, IACUC, IBC, FCOI and R&DC that meet the following requirements:Options for generation of agenda either by VA-defined rules concerning steps of the review process completed, manual selection, or combination of both processes.Agendas shall list protocol title, Principal Investigator, type of review, required component reviews, research staff in conflict with any of the review committee members, and shall have a separate function to additional items as needed.Agendas shall allow editing by committee administrators as needed.The System shall provide for automatic generation of IRB, SRS, IACUC, IBC, FCOI and R&D Committee minutes that meet the following specifications:Minutes shall list protocol title, Principal Investigator, type of review, required component reviews, research staff in conflict with any of the review committee members, details of the vote including numbers for, against, recused, and abstaining. Inclusion of customizable text to reflect discussion of each business item.Minutes shall allow editing by committee administrators as needed.Ability to track and report SAE/AE with reports to include protocol title, investigator, study intervention, or other VA specification.Automatically generated notification/decision letters with customizable text for all protocols approved by the IRB, SRS, IACUC, IBC, FCOI and R&DC.Data Conversion Kit Existing protocol data shall be migrated to new system and shall include basic project information to include title, current staff, current expiration dates for each committee review, BUA if applicable, and type of protocol (one or more of human, animal, or bench).Contractor shall lead a kick off meeting NLT 60 days after contract execution and shall provide a detailed plan for system rollout based on the current practices and needs of the VA.Contractor shall provide onsite training and support during the configuration process that is specifically targeted for the Research Service Administrative Staff which deals with initial set up, applications and use of system. Additional training will be provided via live Webinar as follows:To accommodate varying schedules, training to the following groups will be offered at least twice, with dates to be determined by VA, who will provide a minimum of 30 days notice to Contractor.PI s and research community on system use and submission of research protocols.Committee members on system use and review of research protocols.Customer support shall be offered M-F from 8:00am to 4:00pm Eastern Time, excluding federal holidays.System shall provide Customer the ability to directly query the underlying database/tables through a third-party reporting tool.The requirement will take place remotely and at the JJP facility in Bronx, NY. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Thursday, Nov 21, 2019, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at Michael.haydo@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.
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- Record
- SN05497392-F 20191120/191120064105 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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