Amend 4.pdf
PDF 102 KB Posted
- Solicitation number
- RFP-75N93020R00011
About this file
This document includes an amendment to a request for proposals and details of a related federal contract opportunity. The amendment extends the proposal due date from October 12, 2020 to October 13, 2020 due to the federal holiday. The contract opportunity is for the National Institute of Allergy and Infectious Diseases Clinical Data and Safety Management Center to provide clinical research data management, safety, and pharmacovigilance services for NIAID-funded clinical trials and studies of immune-mediated diseases. Required services include management of clinical study data in Medidata and REDCap Cloud systems, safety data in Oracle Argus On-Premise software, and support for programs such as the Immune Tolerance Network, Asthma and Allergic Diseases Clinical Research, and Autoimmunity Centers of Excellence. The National Institutes of Health National Institute of Allergy and Infectious Diseases will award the contract.
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Other files
| File | Type | Posted |
|---|---|---|
| Att 22 CumulativeInclusionEnrollmentReport.docx | DOCX document | |
| Attach 25 Emp sep checklist.pdf | ||
| Amend 3 .pdf | ||
| RFP 20R00011-2.pdf | ||
| RFP 20R00011-1.pdf | ||
| RFP 20R00011_OA 06012020.pdf |
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Text version
Amendment 4
RFP 75N93020R00011
NIAID Clinical Data and Safety Management Center (CDSMC)
1. Are the studies in a Medidata URL/tenant that can be transferred to the new contractor?
Answer: The majority of clinical study data are supported by Medidata’s cloud-based Rave Electronic Data Capture (EDC) software with a small number of Network studies in development intending to use REDCap Cloud. In both cases, these studies can be transferred via URL. Safety data to be managed by the CDSMC is currently supported through Oracle Argus On-Premise Enterprise software.
2. Would you consider changing the dues date, since October 12, 2020 is Columbus Day and it is a Federal Holiday?
Answer: The due date is extended until 3:00 P.M. ET on Tuesday, October 13, 2020.
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