Att F - Data Disclosure Clearance Form.docx
DOCX document 29 KB Posted
- Attached to
- Safe Medication Use
- Solicitation number
- 75F40125Q00401
About this file
This document is a Data Disclosure Clearance Form from the Food and Drug Administration (FDA) designed to facilitate the public release of aggregated limited rights data. The form provides a structured mechanism for contractors to request clearance for releasing data through various channels such as publication, research, or presentation. It requires electronic submission of specific details including drug file names, query file names, and dates of planned releases, with the contractor expected to provide clearance via email.
The form is specifically related to a FDA/CDER solicitation (75F40125Q00401) for "Safe Medication Use" seeking medication error data collection and analysis services. The solicitation aims to acquire comprehensive medication error case reports from across the U.S. population, including detailed information about error types, origins, specific products involved, contributing factors, preventative actions, and associated adverse events. The FDA is specifically seeking unlimited, multi-user access to a web-based analytics platform containing at least 5 years of medication error case reports to support surveillance and public health safety monitoring activities.
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Other files
| File | Type | Posted |
|---|---|---|
| 75F40125Q00401-SafeMedUse-QA.pdf | ||
| Att D - FDA Form 3398.pdf | ||
| Att A - Records management cert.pdf | ||
| SOL_RFQ (75F40125Q00401) SafeMedUse.docx | DOCX document | |
| Att C - Pricing Worksheet.xlsx | XLSX spreadsheet | |
| Att E - Data Disclosure Clearance Procedures.docx | DOCX document | |
| Att B - Records management training.pdf |
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Text version
DATA DISCLOSURE CLEARANCE FORM
COVER SHEET - FDA CLEARANCE REQUEST FORM
INSTRUCTIONS:
- Review Data Disclosure Clearance Procedures before completing this form.
- For all requests, complete "Clearance Type/Requestor Information" and "Project" sections.
- For requests to publicly disclose Aggregated Limited Rights Data, complete "Section I."
Date:
| Contractor's Address: |
| Client’s Address: |
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
| Contact Name: |
| Contact Name: |
| Telephone: |
| Telephone: |
| E-mail: |
| E-mail: |
CLEARANCE REQUESTOR INFORMATION:
| Clearance Request |
| Date of this Clearance Request: |
| ☐Public Release of Aggregated Limited Rights Data by FDA (complete project description and Section I) |
| Request form completed by: |
PROJECT DESCRIPTION:
Name(s) and description(s) of FDA project associated with the use of the data:
FDA contact(s) for the project(s):
SECTION I: Public Release of Aggregated Limited Rights Data by FDA
Purpose of Aggregated Limited Rights Data use:
| ☐Publication |
| ☐ Research |
| ☐ Presentation |
| ☐ Other, please specify: |
The following items must be provided electronically by FDA with this Clearance Form (if practicable):
Date(s) of publication(s), presentation(s), or forum(s) (if known):
Drug file name:
Query file name (if applicable):
Contractor shall provide clearance by e-mail for the release(s) identified in this Section I.
File details come from the government source that posted it. Updated .