Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 01, 2017 FBO #5669
DOCUMENT

A -- Research Protocol Management System. Vendor shall provide Software as a Service in the form of a web-based protocol management system that provides for online submission by tracking of VA research protocols through their lifecycle. - Attachment

Notice Date

5/30/2017
 

Notice Type

Attachment
 

NAICS

541720 — Research and Development in the Social Sciences and Humanities
 

Contracting Office

US Department of Veterans Affairs;Veterans Health Administration;Service Area Office (SAO) East;323 North Shore Drive, Suite 500;Pittsburgh PA 15212-5319
 

ZIP Code

15212-5319
 

Solicitation Number

VA24017Q0149
 

Response Due

6/7/2017
 

Archive Date

6/12/2017
 

Point of Contact

Linda Buccigrossi
 

Small Business Set-Aside

N/A
 

Description

SOURCES SOUGHT NOTICE Protocol Management System for the New Mexico Veterans Affairs Health Care System DESCRIPTION OF REQUIREMENT The New Mexico Veterans Affairs Health Care System (NMVAHCS) requires the following service: Research Service Protocol Management System. Vendor shall provide Software as a Service, in the form of a web-based protocol management system that provides for online submission by researchers and tracking of VA research protocols through their lifecycle and archival. Contractor will provide and manage the infrastructure that houses research protocol information. System will provide for 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 NMVAHCS Research Service (referred to as Customer). This notice 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 to the contracting office no later than Wednesday, June 7, 2017 at 12:00 Noon, EST. Interest/capability statements may be sent to Linda Buccigrossi, Contracting Officer, at linda.buccigrossi@va.gov and should include company name, address, and point of contact, business size, socio- economic status; and product information. No telephone responses will be accepted. This notice is to assist the Government in determining sources only. A solicitation is not currently available. If a solicitation is issued, all interested parties must respond to that solicitation announcement separately from the responses to this announcement. ***When submitting responses via email, please be sure to type PROTOCOL MANAGEMENT in the subject line*** Period of Performance is expected to be a Base + 4 option years. Type of Contract: Firm Fixed Price SPECIFIC REQUIREMENTS Contractor to provide a web-based research protocol management system that will provide electronic document management and web-based protocol sharing of electronic proposal 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 electronic versions of Customer s 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. Frequency of backups should be at least every 24 hours 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, Privacy Officer, Information Security Officer 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) NMVA Institutional Review Board (NMVA IRB) Sub Committee for Research Safety and Biosafety (SRSBS) Institutional Animal Care & Use Committee (IACUC) Institutional Biosafety Committee (IBC) Tracking of NMVAHCS research protocols submitted to and approved by VA Central IRB shall allow for upload of protocol, approval letters, and other relevant correspondence for the following: 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 NMVAHCS 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. 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. Ability to configure out of fully convened committee actions (such as expedited reviews for IRBs or Designated member reviews for the IACUC). Shall not repeat any questions already answered as a part of the Request to Review Research Proposal Wizard, the IRB Review Wizard or the Basic Science Study Wizard. Request to Review Research Proposal Wizard 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, Principal Investigator, study staff, type of research being conducted, funding source, funding period, funding administrator (including CRADAs and MOUs), required approvals 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. Shall document the activities of the review committees including initial review, continuing review approvals. Application for IRB Review Wizard Shall request information regarding subject population, risk assessment, informed consent, research procedures, investigational drugs and/or devices, and conflict of interest. Application for Animal Care and Use Wizard 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 Wizard Shall request information regarding the use of items such as wet lab space, cell or tissue samples, and shipping of biological hazards, microbial agents, recombinant DNA, animals, chemicals, chemical inventories, controlled substances, ionizing radiation, non-ionizing radiation, and physical hazards. Shall include forms for the Subcommittee on Safety and Biosafety as well as the Institutional Biosafety Committee VA Data Privacy and Security Plan Wizard Wizard 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 will direct the 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 type of 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, allows 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, SRSBS, IACUC, IBC and R&DC Committees. Expiration of personnel qualifications, training, appointment status, scopes of practice and financial Conflict of Interest COI) 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 at least the following: Name Date of current curricula vitae or resume Credentials (up to four) Option to capture three email addresses Study Role (with the ability to have different roles on each study assigned) VA appointment type with expiration date Scope of practice with expiration date Scope of practice addendum for each study Identify if working with animals (identify type) Track animal medical clearance with expirations Identify if working in laboratory or with other hazards 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). Ability to import relevant records from the VA Talent Management System (TMS) into the system. Ability to manually add training records if not in CITI or 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 all committees (IRB, SRSBS, 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 include location, date and time of meeting, anticipated attendees, list protocol number and 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 will allow for addition and tracking of business items Agendas shall allow for formatting, editing of agenda templates and agendas by committee administrators as needed. Agendas shall allow for pagination. The System shall provide for automatic generation of Committee minutes that meet the following specifications: Minutes shall list protocol number and title, Principal Investigator, type of review, required component reviews, research staff in conflict with any of the review committee members, discussion, controverted opinions, 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 code committee member and investigator names (substitute name with unique number for final minutes of the IACUC). Ability to track and report Events including Serious Adverse Events/ Adverse Events with reports to include protocol title, investigator, NMVAHCS location, study intervention, or other VA specifications. Automatically generated notification/decision letters with customizable text for all protocols approved by the each committee as appropriate. System will 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 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 or Data Use Agreement if applicable, and type of protocol (one or more of human, animal, or bench). System will allow for administrative upload of all current documents. 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. Provision of user manual Contractor will provide assistance in configuration and implementation. Additional training will be provided via either onsite or live Webinar as follows: To accommodate varying schedules, training to PI s and research community on system use and submission of research protocols will be offered at least twice, with dates to be determined by VA, who will provide a minimum of 30 days notice to Contractor. Per training cost provided in contract. Webinar training to be provided as needed at least 3 sessions with ability to schedule additional sessions per contract price. Training to each of the committees on system use and review of research protocols will be offered with dates to be determined by VA, who will provide a minimum of 30 days notice to Contractor. Customer support shall be offered M-F from 7:00am to 7:00pm Mountain Time, excluding federal holidays. System shall provide Customer the ability to directly query the underlying database/tables through a third party reporting tool. Upon termination of this agreement, the vendor will provide a copy of all data in appropriate, readable format. If applicable, vendor will provide data in a format to allow for expeditious data migration.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/9bd26150671ec80a8d323a1e650a0947)
 

Document(s)

Attachment
 

File Name: VA240-17-Q-0149 VA240-17-Q-0149.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3535097&FileName=VA240-17-Q-0149-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3535097&FileName=VA240-17-Q-0149-000.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: New Mexico VA Health Care System;1501 San Pedro Drive SE;Albuquerque, NM

Zip Code: 87108
 

Record

SN04526102-W 20170601/170530235138-9bd26150671ec80a8d323a1e650a0947 (fbodaily.com)
 

Source

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

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