Amendment2_Attachment1_QuestionsAnswers_FINAL.docx
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- Attached to
- NINDS Center for Clinical Trial Resources
- Solicitation number
- 75N95022R00014
About this file
This document includes a questions and answers file related to a request for proposals for a National Institute of Neurological Disorders and Stroke Center for Clinical Trial Resources. The contractor will be required to provide scientific resources and services to support clinical research sponsored by NINDS, including maintaining and updating common data elements, reviewing standard operating procedures for archiving, and providing copyright protection documentation support. The performance period is divided into four areas, with an estimated 75-80% of effort allocated to maintenance and updating of common data elements. The due date for proposals was extended from June 20, 2022 to June 30, 2022. The contract type will be cost-reimbursement for an indefinite delivery/indefinite quantity with a one-year base period and four one-year options. The total level of effort is estimated but will vary based on annual NINDS priorities across the four performance areas.
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Questions and Answers - 2
Request for Proposals (RFP) Number: 75N95022R00014
Project Title: NINDS Center for Clinical Trial Resources
| Question Number |
| Question and Answer |
NINDS Responses
1.
Attachment 1, Statement of Work, Performance Area 3, #1, page 6; Review the current SOPs for archiving and provide comments to NINDS on alternative processes that would present cost savings or improve processes without an increase in cost
Question: How many SOPs for archiving is NINDS expecting the Offeror to review?
We do not have an estimated quantity, but we anticipate a low number of new SOPs would need to be created. The services would also include some updating of existing SOPs.
2.
Attachment 1, Statement of Work, Performance Area 4, #6, page 8; Copyright Protection Documentation Support
Question: How many copyrighted and trademarked instruments are in the CDEs?
To clarify, the contractor is expected to keep the Notices of Copyright updated. This includes a current link to the copyrighted/trademarked instrument and the information in the form. It will vary from CDE to CDE, but the approximate average is 69.
The NINDS CDE Team does not post proprietary instruments/scales as recommended by the CDE Working Groups on this website. This includes, but is not limited to, copyrighted or trademarked instruments/scales. Information about recommended instruments can be found in the Notice of Copyright (NOC) documents under ‘CRF Module/Guidance’ on each disorder’s data standards page. For any questions regarding these instruments/scales please contact the corresponding owner/author. The NINDS CDE Team is not responsible for the availability or content of these external sites, nor does the NINDS CDE Team endorse, warrant, or guarantee the products, services or information described or offered at these other internet sites
For additional information, please refer to this link: Stroke | NINDS Common Data Elements (nih.gov)
3.
Attachment 1, Statement of Work, Performance Area 4, #5, page 8; Maintenance and updating of the CDEs
Question: Can NINDS provide a description of the activities involved and the level of effort expected to maintain and update CDEs?
Please refer to page 6 – 9 of the SOW.
Although it is expected to vary from year-to-year based on NINDS priorities, below is an approximate annual percentage of the Level of Effort for each performance area:
Performance area 1: 10-20% Performance area 2: 0-5% Performance area 3: 5-15% Performance area 4: 75-80%
Refer to Article F.3 Level of Effort for the total estimated Level of Effort for each year. This is only an estimate. Offerors should propose the labor effort and labor mix appropriate for its proposal.
| 4. |
| Question: Considering the extensive requirements in the RFP, would NINDS consider a due date extension to June 20, 2022? |
The NINDS is unable to accommodate a two-week extension but is extending the deadline by one week. New due date is June 30, 2022 at 10am EST.
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