Final RFP 75N9301900027 QA's_ Amendment 1.pdf

Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious

Diseases RFP: 75N93019R00027 AMENDMENT 1 Issued by: NIAID

RFP Q&A’s

Number Contractor Questions NIAID Response

1. What is the current data collection system being used? Per the SOW p. 70, the system is a proprietary electronic data capture system (non-commercial off the shelf {COTS} system).

2. What is the current study/protocol management system? For clinical study websites, Offerors are to propose an approach to meet requirements in the RFP (SOW III.4 pdf p. 73).

3. What clinical sites would we be supporting? Please refer to the RFP SOW I p. 70 and Attachment 5 p. 96.

4. What is the current electronic specimen tracking system? Please refer to response to question number one.

5. What are the labor categories? Offerors are to propose labor categories to meet the requirements specified in the RFP.

6. Where is the current central facility and does it need to remain at that location?

Please refer to the response to question number one, and no, the current central facility does not need to remain at the current location.

7. What are the IT system requirements? Not applicable. RFP will be amended to remove language from Section 8: Other Considerations – Information Technology (IT) Systems Security. p. 126.

8. We assume that the incumbent will transition to the new contractor developed intellectual property/capabilities that can be continued by the new contractor? Can NIAID share what these will be? Will this include a transfer of the webpage?

As listed in Attachment 8: Additional Business Proposal Instructions and Uniform Cost Assumptions, p. 128, Study Websites assumes the following:

“300 clinical trial-specific websites involving, 20,000 web reports; 7200 documents posted; and 2500 active website users at the time of award,” further, for new trials, “…a total of 5,000 users requiring access to various websites at any time…”

Assume content of the clinical trial-specific websites will transition.

9. We assume that the webpage supports only the researchers and not patients? The veracity of the documented data entry is

Assume yes.

Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

RFP: 75N93019R00027

Issued by: NIAID

RFP Q&A’s

Number Contractor Questions NIAID Response beholden to the researcher. Will DMID offer index and rules on each field related to data input?

10. What is the total number of internal DMID staff and participating sites?

Refer to response to question number eight.

11. Can DMID share the number of Help Desk Calls per week? Per the SOW p. 78, “Provide and maintain a 24 hour/7-day per week accessible help line to receive statistical and data management questions and related requests for SDCC assistance from study sites. This help line shall be in place and fully operational within 60 calendar days from the effective date of the contract.” Assume four calls per week.

12. Can we employ COTS Technology for building the website and the data capturing requirements?

Assume yes.

13. What is the number of external contractor vendors currently supporting the current contract?

Please refer to Attachment 5, Definitions and Information, p. 96.

14. What is the clinical data system currently being used to support the current active studies?

Refer to response to question number one.

15. Does the government have a set of data collection standards that are required to be used for new studies?

Offerors are to propose an approach to meet the requirements specified in the RFP.

16. Will this requirement be supported by the standard help desk support provided by the clinical data collection system used for the studies that support all system related questions? Or will

Please refer to response to question number 11.

Issued by: NIAID

RFP Q&A’s

Number Contractor Questions NIAID Response this request require additional support to cover protocol specific questions?

17. Can the government provide the estimated number of resources of the data management support for the current contractor?

Assume no and Offerors are to propose approaches to meet the requirements specified in the RFP.

18. This section refers to the development of an SAE reconciliation SOP. Will the contractor be required to follow Government processes and procedures to support the entire scope of the contract or will the contractor follow their internal processes and procedures to support the work?

Per the SOW p. 102, “The Contractor shall compare and reconcile Adverse Events in the SDCC clinical data system with the separate DMID-CROMS pharmacovigilance (PVG) Serious Adverse Event (SAE) database. The contractor will develop an SOP to describe the process for such reconciliation in collaboration with the DMID-CROMS contractor, with a delivery schedule for the SOP and any updates determined by the COR and/or DMID staff designated by the COR.”

19. Since Subcontractors are required to submit their cost proposal in the same format as the offeror's cost proposal, will the Government permit Subcontractors to submit this to the Government directly, in order to preserve proprietary rate calculation details?

20. Can the Government confirm that Subcontractors will submit their cost proposal (including proprietary rate calculation details) through the NIH eCPS website?

21. Can the Government identify the number of Principal Investigators that are in place today, and whether there are sufficient FTEs in place to support the workload?

Assume no. Offerors are to propose an approach for Key Personnel based on the requirements in the RFP.

22. Can the Government identify the Other Professional labor categories that are in place today, how many FTEs there are for each labor category, and whether there are sufficient FTEs in place to support the workload?

Refer to responses to questions 5 and 21.

23. Can the Government identify the Technical & Support labor categories that are in place today, how many FTEs there are for each labor category, and whether there are sufficient FTEs to support the workload?

Refer to responses to questions 5 and 21.

24. Can the Government provide an organization chart of the existing positions staffing the NIAID SDCC currently?

Assume no. Offerors are to propose an approach to meet the

25. Questions are due to the Government by 12/22/2019. If the Government does not provide responses to questions by 1/07/2020, will the Government consider extending the due date of the proposal to ensure offeror's can address any new information or clarification resulting from the Q&A?

Assume no.

26. Aside from the clinical data system, is there a collaboration tool or web presence (i.e. SharePoint or other) furnished by the Government in order for the SDCC team to house and share non-clinical data system files and other documents? If so, what is the tool used for such coordination and collaboration? If not, does the Government require the vendor to provide a collaboration tool and associated pricing?

Assume no. Offerors are to propose an approach to meet the

27. Can the Government identify the Key Personnel that are likely to be considered essential to work performance, and how many FTEs are estimated?

Offerors are to propose Key Personnel essential for performance of the requirements specified in the RFP.

28. Does the Government's "centralized data management" solution include the use of a Clinical Trial Management System (CTMS)? If so, is there a preferred CTMS that the NIAID SDCC desires to use? If not, does the Government require offerors to propose one with associated costs?

A Clinical Trial Management System is not a requirement of the RFP. Offerors shall propose an approach to meet the requirements specified in the RFP.

29. Does the Government's requirement to "operate and maintain a state-of-the-art computer-based clinical data system" imply that a system is already in place (and provided for by the Government) or are offerors to propose a new system and include associated costs?

(clinical data system)

Refer to the SOW p. 71, “…the Contractor shall operate and maintain a state-of-the-art computer-based clinical data system for data collection, storage, tracking and retrieval. This system must be in place and fully operational within 60 calendar days from the effective date of the contract. The Contractor shall provide the following system features and capabilities…”

30. Does the Government's requirement to "operate and maintain a state-of-the-art computer-based clinical data system" imply that a system is already in place (and provided for by the Government) or are offerors to propose a new system and include associated costs?

(specimen tracking system)

Refer to the SOW p. 78, “…the Contractor shall provide and maintain an electronic specimen tracking system, for use by the SDCC, study sites, laboratories and others as designated by the COR to track study specimens in real time. This system must be in place and fully operational within 60 calendar days from the effective date of the contract. The electronic specimen tracking system shall have the following features and capabilities…”

31. Can the Government clarify if data storage will be provided at Government sites, or will the contractor need to provide off-site specimen storage (i.e. freezer farm)?

Specimen storage (i.e. freezer farm) is not part of the RFP.

Specimen-related data is as explained in the SOW p. 78. Also, please refer to response to question number 30.

32. Can the Government provide examples of the types of specimens that may be required for clinical data storage?

Additionally, will specimens be stored on-site at Government facilities, or will the contractor need to provide off-site specimen storage?

Refer to response to question number 31. Research specimen types include sera, pbmcs, urine, nasal wash, etc.

33. To ensure we estimate costs accurately, of the estimated total 5,000 users requiring access to the websites at any time, can

Refer to Attachment 8: Additional Business Proposal Instructions and Uniform Cost Assumptions p. 127.

the Government provide an estimate of the existing systems concurrent usage?

34. Offeror understands the agency is already using an electronic data capture system (EDC). Will the agency be retaining the same EDC and requiring its use under the resulting contract? If the intent is to replace the EDC under the new award, Offeror may be able to deploy COTS software options as part of the services. Such COTS software would be subject to standard commercial terms. For COTS software, will the agency amend the solicitation to include FAR 52.227-19, Commercial Computer Software License, and not require delivery of object or source code for such COTS software?

Per Article B.1 p. 4 “…the scope of activities to be performed by the Contractor shall encompass development and operational management of a Statistical and Data Coordinating Center….”

Offeror shall propose an approach to meet the requirements specified in the RFP. The approach can include a non-COTS or COTS system. The delivery of object or source code will be determined at time of award, as applicable.

35. For Past Performance information, NIAID requests, "A list of the last 3 contracts completed during the past Five years and all contracts that are currently being performed that are similar in nature to the solicitation work scope." Would NIAID consider limiting current contracts to those that are directly relevant to the requested RFP services?

The requirement per the RFP, p. 44, is “…all contracts that are currently being performed that are similar in nature to the solicitation work scope”. Therefore, current contracts are already limited to those that are similar in work scope.

36. Please confirm whether an Offeror may utilize its own existing subcontract plan template, presuming it includes the information required by the HHS template/Subpart 19.7, or if the HHS Subcontracting Plan Template is preferred/required.

Assume yes.

37. There is instruction to "Include the Attachment “Packaging and Delivery of the Proposal”, with the SP". - please clarify what is requested. What is the "SP"?

This language will be removed.

38. The requirements state, "The Contractor shall operate and maintain a state-of-the-art computer-based clinical data system for data collection, storage, tracking and retrieval. This system must be in place and fully operational within 60 calendar days from the effective date of the contract." Does "fully

Per the Delivery Schedule p. 109, “due to be in place and fully operational within 60 calendar days from the effective date of the contract.” Assume fully operational means the data system must be ready to be implemented in clinical trials.

operational" mean that the data system must be ready to use, but not fully customized (eCRFs, etc.) for all active clinical trial protocols?

39. What monitoring approach is used in the DMID trials? Does the data system need to accommodate trials using a risk-based monitoring approach?

Assume monitoring approaches vary, to include risk-based monitoring, and are included in study-specific monitoring plans.

Please refer to the SOW p. 74.

40. Regarding the SOW activity Data Storage, can NIAID provide an estimate of the total file size? That is, what is the total storage capacity that the contractor will need to provide in its storage location?

Offerors are to propose an approach that meets the requirements specified in the RFP. Per Attachment 8:

Additional Business Proposal Instructions and Uniform Cost Assumptions, p. 128, “...assume 200 completed trials/studies for which data are archived” at time of award.

41. Is the information covered under this contract considered controlled unclassified information (CUI)?

Assume no.