SOURCES SOUGHT
D -- Protocol Review Tool
- Notice Date
- 5/20/2009
- Notice Type
- Sources Sought
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- HHS-FDA-SS-09-1056184
- Archive Date
- 6/11/2009
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Description: Protocol Review Tool This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and woman-owned small businesses) to support as needed for a web based meta-data-driven tool for protocol review. This information is being sought for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA). No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. No telephone inquiries will be accepted. FDA may consider soliciting services for a base year and one option year. Objectives: The ultimate goal of this project is a web-based, meta-data-driven tool for clinical protocol review. Draft Scope of Work: Entered data are retained in a database to support querying and report generation. The user can generate an output Word document suitable for entry into DARRTS. The prototype has been implemented in Microsoft Web Developer. The production tool should use ColdFusion. The backend database in the prototype is SQL Server. Other options for the database will be considered. The tool operates in a secure environment, so you can obtain the user name from the user’s Windows login. His review division (in this case, HFD-110) comes from a local database table. Pending work (IND/Submission) should come from the administrative database (DARRTS). How to do that will need to be negotiated with CDER Office of Business Process Support. (The pilot uses a local database table.) Some information (sponsor, dates) should also be obtainable from the administrative database (DARRTS). User-entered data are organized in a series of tabs (Admin, Design, Comparators, etc.; see Figures 1, 3-6). Content and layout, etc. for the form are described in a local database table (Metadata; see Tables 2 and 3). User form control types are limited to free text or numbers, drop-down lists, and three-state (yes/no/no answer; here implemented with a set of radio buttons). Free text does not require rich text formatting. Every form control has explanatory float-over text (Metadata.Tooltip). Every form control has an associated optional note. The notes use embedded Word to support arbitrary formatting. (All users will have Word installed.) In the final output report, the user can have a note appear as either a footnote or in parentheses. For the most part, one protocol review has one value for each form control. This model breaks down for describing a study’s end points. The contractor will need to do further requirements gathering so that a solution can be crafted that captures multiple endpoints, their relationships among one another, and the data elements associated with an individual end point. This should still be implemented as metadata, so that further enhancements are possible. The pilot implementation went to XML for endpoints; perhaps the entire form metadata ought to be XML. Upon attempt to generate a filable report, the system executes a set of validation rules, stored in Metadata. Some rules enforce database constraints on data types, range, or nullability (see Metadata.IsRequired, Metadata.Choices). Other rules require responses to a set of form controls depending upon another response. For example, if the study enrolled women, then you must answer questions about enrollment criteria regarding pregnancy (see Metadata.RequirementSet.) Some rule violations prevent report generation. The user should be prompted to where those problems are (link from error message to Tab and form control). Some rules should generate warning messages (for example, a large study enrollment with no statistical consult indicated). All database transactions occur through stored procedures. The report output should be controlled through a Word template. The default should be a standard, centrally managed template, but a reviewer should be able to substitute a template of his own. The report generator should support some macro expansion that substitutes form values into the output and enables proper English. The reviewer can view a summary of previously reviewed protocols for the same IND application (History tab). The generated Word report should have a summary of previously reviewed protocols. A partially functional Web Developer prototype is available for perusal, but specific details do not need to match the prototype. We may anticipate a labor hour type contract with a base year plus one option year. Viable parties shall provide the following: Part A. Capabilities and Technical Experience – Provide a capability statement describing how your company would provide a web-based meta-data driven tool for clinical protocol review. Part B. Size of Business- Please provide your business size and submit copies of any documentation such as letters or certificates to indicate the firm’s status. Part C. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of a web-based meta-data driven tool for clinical protocol review. Part D. Cost Estimate - Provide a cost estimate for the services (i.e. hourly rates, hours/days) and the number of hours in the performance of a contractor to provide a web-based meta-data driven tool for clinical protocol review. Part E. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation on Subcontracting. Responses shall be: -identified with the Sources Sought number ; -no more than ten (10) pages in length; -not submit marketing materials; -submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/HHS-FDA-SS-09-1056184/listing.html)
- Record
- SN01823948-W 20090522/090521004825-481a8e54bc2e6925b047203e147174b9 (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 |