Questions and Answers.pdf

Questions and Answers

1. Given the extramural nature, please confirm the names and locations of the clinical center(s) and associated investigators, coordinating center, and drug distribution center(s) subject to audit.

This information needs to be kept confidential and cannot be shared as part of the solicitation. It will be shared with the contractor after award.

2. Within the Background section of the SOW, please confirm the associated NIDDK consortium and protocol title of the multi-center randomized clinical trial that worked with the “Coordinating Center and 20-some clinical centers.”

This information needs to be kept confidential and cannot be shared as part of the solicitation. It will be shared with the contractor after award.

3. Please confirm the number of audits expected during the Base Period (6 months) and the number of audits expected in Option 1 (6 months).

Audits are to be completed during the Base Period. Audits will be required at all or a subset of the approximate 25 participating clinical centers, a Data Coordinating Center, and subcontract entities (e.g. central drug distribution center) depending on the strategy proposed and the ability to adjust the strategy per findings from audits as they are completed.

The number of audits required in the 6-month option period will be dependent on the findings during the Base Period. No or a limited number of follow-up audits are anticipated if the six-month option period (Option 1) is exercised.

4. We understand this engagement will include vendor audits – please specify the total number of potential vendors to be audited, types of services provided, and the location.

Audits at up to 25 participating clinical centers, a Data Coordinating Center, and possibly subcontracted entities such as a central drug distribution center may be required, per the strategy that is developed by the contractor. One or more audits at a given location may be required depending on findings from audits as they are completed.

5. Will the Audit Support contractor have access to the referenced investigations and reports previously conducted by the IRBs, NIH, NIDDK, etc.?

The Audit Support contractor will have access to all information currently available to the NIDDK Office of Clinical Research Support and the ability to gather additional information via access to representatives at the participating clinical centers, Data Coordinating Center, and subcontract entities (e.g. central drug distribution center) as appropriate.

6. Within the Deliverables and Reporting Requirements Table (page 4 of 5 of SOW), we have the following questions/suggestions:

a. Final Audit Report: To keep these reports independent from the Government, would the Government consider removing the “NIDDK approval” from this process? The NIDDK can certainly keep the 'review of the draft,’ if absolutely necessary.

Reference to “NIDDK approval” is a function of contract management to confirm receipt of complete and comprehensive audit reports, aligned with the agreed upon audit template, report template, and audit activities performed. “NIDDK approval” is not intended to imply review/editing of individual audit report content or findings.

b. Draft Audit Report: The timeline for delivering a Draft Audit Report within 7 days of audit is very tight. Per industry standard, it is customary to have 21 calendar days to deliver the audit report. Would the Government consider amending the Draft Audit Report due date?

Given the need to visit up to 20-some participating locations during the six-month Base Period, the turnaround times for audit reports is necessary to complete the work, adjust the strategy as appropriate based on findings from completed audits, and generate a final cumulative summary report to inform NIDDK leadership.

7. Is NIDDK planning to only audit 1 Clinical Center – that had the compliance issue in 2020. Or is the intention for Audit Service for all 20 Clinical Centers conducting trials with NIDDK.

Audits at up to 25 participating clinical centers, a Data Coordinating Center, and possibly subcontracted entities such as a central drug distribution center may be required, per the strategy that is developed by the contractor. One or more audits at a given location may be required depending on findings from audits as they are completed.

8. Does NIDDK want a separate document (Cost Vol) for the Pricing?

That is not necessary. Either or is fine.

9. Please confirm if there is a page limit for the Technical document.

There is none.