SOURCES SOUGHT
70 -- Compliance/Facility Management Software Program
- Notice Date
- 6/1/2007
- Notice Type
- Sources Sought
- NAICS
- 511210
— Software Publishers
- Contracting Office
- Department of Veterans Affairs;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
- ZIP Code
- 10468-3904
- Solicitation Number
- VA-243-07-RI-0056
- Response Due
- 7/1/2007
- Archive Date
- 7/31/2007
- Small Business Set-Aside
- N/A
- Description
- Compliance/Facility Management Software Program: Vendor must be knowledgeable with and have experience in VA requirements in the field of Human Subjects (IRB) and Animal Research (IACUC), VA Biosafety and Research and Development Committee function as well as and animal facility management Software program should be capable of the following: IRB compliance: Meeting Agenda, record meeting activities, and generate notification letters of IRB Meeting actions. Maintain historical data base of records, allow for the recording and creation of a permanent record of Serious Adverse Events, IND Reports, and Medwatch numbers, and automatically place Study on agenda for on-site and user-specified event types. Includes Informed Consent Checklist for review of the FDA and other required elements. Education tracking for all participants with reminder letter capabilities. Provide for printing, e-mailing, and customization of letters via integration with MS Word templates. Provide for recording Protocol Revisions. Generate Continuing Review notification letter(s) and provides for follow-up on receipt of a Progress or Final Report. Maintain a database of Investigators, Sponsors, and Study Coordinators. Support for multiple Boards. Provide for the electronic submission of new protocols by Investigators, including Protocol Summaries, Protocol Checklists, Consent Documents Templates, Drug Information Sheets, Device Information Sheets, and Routing Sheets. Allow for online review of protocols and related correspondence. Provide electronic submission of Serious Adverse Events, Continuing Review Applications, Protocol Revisions, Consent Revisions, and other correspondence utilizing Custom User-Specific Templates. Support the use of notebook computers for all IRB members. IACUC Compliance Management. Allow for the automatic creation and generation of 30, 60, and 90 days warning letters. Create approval, conditional approval, deferred and decline letters automatically based on the outcome of the meeting and create both the minutes and agenda. Create program review and training tracking. Create electronic and hard copies of above documents. Create IBC compliance Meeting Agenda, record Meeting activities, and generate notification letters of IBC Meeting actions Protocol submissions. Create R&D compliance Meeting Agenda, record Meeting activities, and generate notification letters of R&D Meeting actions Protocol submission. Create training compliance tracking. Create Occupational health tracking. Allow for online protocol submission Web Based Protocol Submission and Review: Online submission review of protocols. Allow for Web based access. Allow for online ordering. Laboratory animal facility management. Allow for animal ordering, the creation of cage cards, delivery reports, and the USDA report, and the invoicing of investigators for animals purchased. Ability to alert the Laboratory Animal Resources (LAR) office when an investigator would exceed the number of animals allowed on a protocol. Allow the tracking, invoicing and reporting on the animals, services, and supplies being used in research. Allow for the creation and printing of individual invoices for each investigator by either name or account number. Allow the management and tracking of information pertinent to each protocol, as well as track investigator animal usage. Allow for generation of reports of animal usage. Allow for tracking and maintenance of information pertinent to each employee and or investigator; including, but not limited to training information. Allow for the tracking of both large and small animal health, including sentinel animals. Allow for cost analysis. Bar Coding and RFID cage cards can be done either by location or by protocol. May utilize PDA's as an alternative.
- Place of Performance
- Address: James J. Peters VAMC;130 W. Kingsbridge Road;Bronx, NY
- Zip Code: 10468
- Country: USA
- Zip Code: 10468
- Record
- SN01308384-W 20070603/070604103037 (fbodaily.com)
- Source
-
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