Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 11, 2018 FBO #6074
DOCUMENT

70 -- Web Based Research Protocol Management System - Attachment

Notice Date

7/9/2018
 

Notice Type

Attachment
 

NAICS

541519 — Other Computer Related Services
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 2;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
 

ZIP Code

10468-3904
 

Solicitation Number

36C24218Q9585
 

Response Due

7/13/2018
 

Archive Date

9/11/2018
 

Point of Contact

Christopher Coker, Contract Specialist
 

E-Mail Address

christopher.coker@va.gov
(christopher.coker@va.gov)
 

Small Business Set-Aside

N/A
 

Description

THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION Only. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. This Request for Information is intended for all Socio-economic groups. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. No solicitation exists. Therefore, do not request a copy of the solicitation. The Department of Veterans Affairs Service Area Office East/Network Contracting Office 2, Bronx, NY team, is conducting market research to identify potential sources with the intention to purchase Web Based Research Protocol Management System services for Northport VAMC. Responses to this notice should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS). This procurement will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. NAICS Code is 541519. Telephone responses will not be accepted. Responses must be received in writing no later than, 1400/2:00PM Eastern Standard Time (EST) on July 13, 2018. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff in regards to this requirement, as they are not authorized to discuss this matters related to this procurement action, all questions will be addressed during the solicitation stage by the Contract Specialist. All firms responding to this Request for Information are advised that their response is not a request for proposal therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the FedBizOpps (FBO) web site for all qualified interested parties at a later date, and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any service. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contract Specialist at christopher.coker@va.gov. WEB BASED RESEARCH PROTOCOL MANAGEMENT SYSTEM STATEMENT OF WORK GENERAL GUIDANCE Title of Project: Northport VA Medical Center Research Service Protocol Management System. Scope of Work: Contractor shall provide software as a service, in the form of a web-based protocol management system that provides for online submission and tracking of VA research protocols. Contractor shall provide and manage the infrastructure that houses research protocol oversight data. System shall provide at least five separate research committees/boards with the tools necessary to support the management, submission, review and oversight of all research protocols submitted to the Northport VA Medical Center. At no time will Contractor have access to any employee or patient Personally Identifiable Information (PII) or Protected Health Information (PHI). VA shall own the rights to all data placed on the Contractor s Servers. No software is to be placed on VA networks. Background: Northport VA Medical Center Research Service provides administrative support and oversight for all VA engaged research conducted within Northport VAMC or by Northport VAMC investigators while on official VA duty. Currently, Northport VAMC oversees research which is conducted at various locations to include, Stony Brook University. There are currently six separate committees charged with the review of research protocols and oversight of research compliance. The Research & Development Committee (R&DC) has ultimate responsibility for approving all Northport VAMC research and has oversight of each of the following subcommittees: Institutional Review Board (IRB), Subcommittee for Research Safety (SRS), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC), and the Veterans Affairs Central IRB. The VA Central IRB is run by the VA Central Office; however, all approvals must be tracked and reported to the R&DC. Research investigators and staff are comprised of many dually appointed employees who maintain appointments with both Northport VAMC and Stony Brook University Affiliate. Many research projects are conducted at multiple sites, necessitating the need for protocol approval from both VA and Stony Brook University. SPECIFIC REQUIREMENTS Contractor to provide a web-based research protocol management system that shall 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 shall be in compliance with CFR Title 21 Part 11. Contractor shall have experience with providing this service to other VA facilities. System to allow for utilization of Customers current forms and workflows and shall provide the following: Unlimited users 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, and Section 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) Institutional Animal Care and Use Committee (IACUC) Institutional Biosafety Committee (IBC) Tracking of NVAMC research protocols submitted to and approved by VA Central IRB shall allow for upload of protocol, approval letters, and other relevant correspondence for the Central Institutional Review Board (CIRB) Ability to add review committees as changing needs require. Unlimited xForms (smart form wizards) that are designed and implemented internally by NVAMC Research Service. xForms 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 xForms. Information compiled from the combination of xForms 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 xForms 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 xForm Shall 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. xForm shall be able to identify any and all subcommittees for which approval is required and direct the user on how to access appropriate xForm or upload other committee approvals. Questions shall be such that the xForm easily directs user to additional forms and/or xForms which shall be required as part of the research submission process. Application for Initial IRB Review xForm - Shall not repeat any questions already asked as part of the Request to Review Research Proposal xForm. 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 xForm easily directs user to additional forms and/or xForms which shall be required as part of the research submission process. Application for Animal Care and Use xForm - Shall not repeat any questions already asked as part of the Request to Review Research Proposal xForm. Shall request information regarding the species of animals (allow for multiple), funding source (allow for multiple), United States Department of Agriculture (USDA) category and any protocol specific training. Application for Basic Science Study xForm - Shall not repeat any questions already asked as part of the Request to Review Research Proposal xForm and if applicable, as part of the IRB Review xForm. 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 xForm easily directs user to additional forms and/or xForms which shall be required as part of the research submission process. VA Data Privacy and Security Plan xForm - xForm 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. System 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, and R&DC Committees. Expiration of personnel qualifications, training, appointment status and scopes of practice and financial conflict of interest forms. 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: Name Credentials (up to four) Option to capture three email addresses Study Role VA appointment type with expiration date Scope of practice with expiration date All 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, 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. Agendas shall allow for addition and tracking of business items. The System shall provide for automatic generation of IRB, SRS 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, NVAMC location, study intervention, or other VA specification. Automatically generated notification/decision letter with customizable text for all protocols approved by each committee as appropriate. System shall allow for external documents to be uploaded when signatures are required by VA authorities not set up as Users in system. Data Conversion Kit Existing protocol data in MIRB shall be migrated to new system and shall include basic project information to include title, current staff, current expiration dates for each committee review, Business Use Agreement 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 shall be provided via live Webinar as follows: To accommodate varying schedules, training to the following groups shall be offered at least twice, with dates to be determined by VA, who will provide a minimum of 30 days notice to the 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, should customer elect to subscribe to the Reporting Server optional component. Upon termination of this agreement, the Contractor shall provide a copy of all data in appropriate, readable format. If applicable, Contractor shall provide data in a format to allow for expeditious data migration. Records Management Language for Contracts Required The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C. chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the Agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents shall be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. The C&A (Certification and Accreditation) requirements do not apply. A Security Accreditation Package is not required for this procurement. As no personal patient data will be stored on any part of this system, no requirement for protection of VA (Veteran s Affairs) data is necessary. DELIVERY: Delivery shall be made no later than 30 days after award of contract. As this is an online software as a service deliverable, Delivery shall consist of making the system available to NVAMC defined administrators and staff for their use in setting up the system. There is no physical deliverable with this contract, and as such no packing slip will be furnished. DELIVERY HOURS: The Northport VAMC accepts deliveries Monday through Friday (excluding federal holidays) between the hours of 8:30 a.m. and 3:30 p.m. (Eastern). TRAINING: The Contractor shall provide onsite and webinar training as outlined in the provisions stated in addition to coordinating onsite and webinar training with the Administrative Office no earlier than 15 days prior to the site visit. SECURITY: The C&A requirements do not apply and a Security Accreditation Package is not required.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BroVANAP/VAMD/36C24218Q9585/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24218Q9585 36C24218Q9585_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4465840&FileName=36C24218Q9585-005.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4465840&FileName=36C24218Q9585-005.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: NORTHPORT VAMC;79 Middleville Rd.;Northport, NY

Zip Code: 11768
 

Record

SN04983715-W 20180711/180709231109-135db830642f7451101a24e985e447f0 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |