DM_RFP_Questions_and_Responses-_Amendment_1.pdf

Data Management and Data Warehousing RFP Questions and Responses

Amendment 1

NIHAO201800011

1. Attachment 1, Packaging and Delivery of Proposals, states that the total page count shall not exceed 50 pages, and lists several items excluded from the page count. CVs are mentioned in the paragraph listing exclusions, but not specifically stated to be excluded. Please confirm that CVs are excluded from the page count.

Response: Yes, CVs are excluded from the page count.

2. Please consider making the following also excluded from the page count: Technical Proposal Cost Summary, Summary of Related Activities, Section 508 Product Assessment Template, and information about Facilities, Equipment, and Information Security.

Response: Yes, these can be excluded from the 50-page count.

3. Attachment 1 limits CVs to 5 pages, while Attachment 4 limits CVs to 2-3 pages. Please clarify desired CV length for this proposal.

Response: Please limit CVs to 2-3 pages.

4. On Pg. 16 (Article F.1.) the start of the period of performance is noted as 8/15/2019. In contrast, the deliverables section (Article F.2.) indicates the first monthly report due in October 2019. Should the deliverable due date be earlier as the contract period of performance is in August 2019?

Response: The first monthly report will be one month after the start of the contract.

5. On Pg. 16 (Article F.1.), the language included in the parentheses for the Options for Increase Level of Effort states “three times per year for years 3-6), but the entire period of performance of 8/15/2019 to 8/14/2026 is 7 years. Should the language above reference “years 3-7”?

Response: Yes, years 3-7.

6. Article F.3 on page 17 states “The labor hours include vacation, holiday and sick leave.”

However, in Section 3, paragraph 2, found in Attachment 5, it is stated that vacation, holiday and sick leave should be excluded from the level of effort. Please confirm whether labor hours for the level of effort should include vacation, holiday and sick leave.

Response: Offerors should exclude vacation, holiday and sick leave from the labor hours.

7. Please provide how each of necessary personnel (listed on pg. 7 of Attachment 3) should be classified by the class of labor (professional, other professional and support) listed in the level of effort table on pg. 18 (Article 3).

Response: Offeror should propose necessary personnel to fulfill the RFP requirements.

8. Should RFP responses include a Small Business Subcontracting Plan?

Response: Yes, they should include a Small Business Subcontracting Plan.

9. On Pg. 28 (Section B #2) the Role-Based Training link does not work and therefore we were unable to evaluate what specific training would be required under this category.

Response: This training will be provided at contract award.

10. On Pg. 53 (Section 13, Past Performance Info), it requests “A list of the last 3 contracts completed during the past Three years and currently being performed that are similar in nature to the solicitation workscope”. Does this mean 3 total or 3 completed + 3 currently being performed?

Response: Past Performance should include 3 total.

11. How many documents will need to be translated (soley data collection forms or is it all of the operational documents)? How many languages will we need translations for? How many of the studies will be international studies?

Response: This will be determined by protocol requirements, what site(s) implements the clinical trial. Please assume the majority of protocol/clinical trials will not require translation nor will be international.

12. How many protocols and records are currently stored in the NIAID CDMS?

Response: There are currently 66 completed and ongoing clinical studies in the CDMS system.

Studies typically have between 10 -2500 enrolled subjects, with an average of 25-45 visits, with 10-25 eCRFs per visit. Eleven completed studies are integrated in the Data Warehouse.

13. What is the toolset (Database, ETL, reporting, visualization) that is part of current DWRT?

Response: The current system uses: SAS programming- internet accessible data base; the extract, transform and load tools (ETL) are allowing integration of SAS files of clinical, immunological and pharmacokinetics essay data from the CDMS as well as Excel raw data files form the labs, and integrated review/ generating reports/ graphs/ tables/ comparison of that data across the studies, products, population groups, etc.

14. Does the customer have any preference for any new toolset?

Response: The customer is open to new tools; however, the proposed tools should meet the level of convenience, accessibility, reliability and usability of the requirements.

15. What is the volume of data entry per month?

Response: An exact number is unknown. This is dependent on which studies are active and protocol requirements.

16. What is the size of the database?

Response: The size is unknown.

17. What is the data archival policy?

Response: VRC does not “archive” data. Study Data are locked as required by protocol and by Good Clinical Data Management Practice and remain in the CDMS. Clinical part of the study data gets extracted from CDMS and gets integrated into the Data Warehouse.

18. What is the version of SAS software that is used?

Response: The most current version of the software is being used.

19. Is the SAS software used for data transformation?

Response: Yes, the SAS software is used for data transformation.

20. In order to develop an overall price on the work to be performed, could NIAID provide a listing of the applications and the technologies used for each of the applications?

Response: This information is proprietary. The offeror should provide a layout of their proposed applications and technologies to fulfill the requirement.

21. Additionally, is there an issue tracker that can be queried for the work that needs to be completed for each of the applications?

Response: This information is proprietary. The Offeror should propose the best technical specification to fulfill the requirements of the RFP.

22. Is there an existing backlog management tool (e.g. Jira) that NIAID is using?

Response: This information is proprietary. The Offeror should propose the best technical specification to fulfill the requirements of the RFP.

23. What DevOps / CI tools are being used today?

Response: This information is proprietary. The Offeror should propose the best technical specification to fulfill the requirements of the RFP.

24. Can the government provide the names of the current extension systems?

Response: This information is proprietary.

25. How should software that is developed be provided to the government?

Response: The software should be web-based, controlled access.

26. Is there a current SCM tool that should be used?

Response: Offeror should propose a SCM tool to meet the requirements of the RFP.

27. Are labor category years of experience and certification requirements at the discretion of the offeror?

Response: Offeror should propose the technical and staffing to fulfill the requirements of the RFP, see Section 4, page 85 of the RFP.

28. Will NIAID please provide data parameters for the CDSM system so offerors can recommend the best system for the government?

Response: There are currently 66 completed and ongoing clinical studies data in the CDMS. In general, studies typically have between 10 - 100 enrolled subjects, with on average 12-25visits, with 10-25 eCRFs per visit completed. However, VRC has enrolled studies of up to 2400 subjects with more than 45 scheduled visits. Eleven completed studies are already integrated in the Data Warehouse. The vendor should plan to have that amount of data hosted and managed, as well be able to develop and maintain the data base for approximately 5-7 clinical trials every year and have the ability to integrate 3-7 studies a year into the data warehouse. The Offeror should also have the capacity to adjust in cases of public health emergency or changes in priorities.

29. Key Personnel Designation. Is the designation of key personnel at the discretion of the offeror?

Response: Offeror should propose the technical and staffing specification to fulfill the requirements of the RFP.

30. Are labor category proposed, years of experience, and certification requirements at the discretion of the offeror?

Response: Offeror should propose the technical and staffing to fulfill the requirements of the RFP, see Section 4, page 85 of the RFP.

31. Are offerors to submit Oral Presentation materials with their proposals?

Response: No, only offerors in the competitive range will be given the opportunity for oral presentations.

32. Is the Solicitation # 75N93019R00003 (which is in the header of the RFP) or NIHAO201800011

(which is in Block 2 of the cover page of the RFP)?

Response: NIHA201800011 is the correct RFP number.

33. Could the government kindly clarify that no PII will be involved in this contract as indicated on page 26 of the RFP in Article H.10.1.3 "Information Security Categorization?" Based on the nature of the scope of work, it appears that personal data will be used in the performance of this contract.

Response: Assume there is a possibility of PII.

34. Could the government kindly confirm that the various information security requirements included in this contract do not apply to vendors that will subcontracted to perform ancillary services such as translation services and 508 compliance services?

Response: They will only apply to the prime contractor.

35. Please confirm the correct solicitation number for this RFP. The cover page references the RFP number as NIHAO201800011 whereas the headers of each subsequent page reference the RFP number as 75N93019R00003. Which is correct?

Response: NIHAO201800011 is the correct RFP number.

36. The link provided for the applicable contract clauses on page 34 of the RFP in Part II - Section I - Contract Clauses does not work. Could the government please provide the correct link to facilitate review?

Response: Link is not working, I will post a working link when it becomes available.

37. Please confirm whether the government is willing to consider utilization of a commercially available software solution for this contract.

Response: Offeror should propose what they feel is the best fit for the government.

38. In accordance with the provisions of a commercially available software solution, would the government kindly consider alternate provision FAR 52.227-19 -- Commercial Computer Software License in lieu of the current FAR 52.227-14 -- Rights in Data - General?

Response: FAR 52.22714 will remain as the Data Rights clause.

39. Could the government kindly confirm that the requirements beginning with paragraph "1. Salary Rate Limitation" on page 56 of the RFP after the conclusion of paragraph "3. Technical Evaluation" are the beginning of the instructions for the Cost Proposal rather than the Technical Proposal?

Response: Yes, these are Cost Proposal instructions.

40. Could the government kindly consider limiting the submission requirements for the subcontractor's cost proposal to the necessary elements for evaluation rather than requiring the submission of a complete cost proposal in the same format as the offeror's cost proposal? In particular, could the government kindly consider eliminating the requirements for subcontractor submission of the Total Compensation Plan, Other Administrative Data, Qualifications of the

Offeror and Annual Financial Report? These requirements align best with the prime Offeror rather than any proposed subcontractors.

Response: As stated on page 62 of the RFP, subcontractor proposals should include a complete cost proposal in the same format as the offeror’s cost proposal.

41. The Technical Requirements on page 70 of the RFP state that the proposed CDMS must be usable within 6 weeks of award; however, this timeline does not take into consideration the need for an authority to operate (ATO). The information security requirements on page 8 of the RFP indicate that an ATO must be completed within three (3) months of contract award. Given the need for the CDMS to be usable within 6 weeks of award, will the government have support staff available to expedite the ATO process? Alternatively, would the government consider an extension of the timeline for the CDMS usability to align with the three (3) months allocated for the ATO?

Response: The government will work with the incoming and outgoing vendors to help facilitate a smooth transition. The government is currently anticipated a two-month transition period.

42. In support of the necessary Data Collection, Management and Quality Control requirements, could the government kindly clarify whether eCRFs for this contract will utilize the existing VRC eCRF library? What is the estimated number of unique eCRFs per protocol? What is the estimated number of repeat eCRFs per protocol?

Response: No, they will not sure the existing VRC eCRF library. Approximately 75% of eCRF’s are unique and approximately 25% are repeat eCRF’s.

43. Can the government provide an expected number of SAEs to be reconciled under the VRC Data Management and Data Warehousing contract? Is there a separate safety database for the VRC?

Response: No, the government does not have an expected number of SAEs to be reconciled and there is not a separate safety database.

44. In support of the necessary Data Collection, Management and Quality Control requirements for the SAE reconciliation, could the government kindly clarify if the Contractor is responsible for safety report distribution?

Response: Yes, the contractor will be responsible for distributing safety reports.

45. In support of the data quality control functions outlined on page 71 of the RFP, could the government kindly clarify whether these data quality control functions should be applied at the overall VRC level or does the government require the Contractor to apply the necessary data quality control functions at only the protocol level?

Response: The Offeror should follow good Clinical Data Management practice, Good Clinical practice, all Clinical Research Federal Regulations, and where all quality control functions are described and defined.

46. In support of the statistical analyses, please provide an estimated number of tables, listings and figures required per each of the VRC protocols?

Response: The Government is unable to provide an estimate, this is based on many factors to include the protocol requirements.

47. Will the government require generation of paper Data Collection Forms (DCF) for each clinical trial or solely on an as needed basis?

Response: Paper Data Collection Forms will be on an as needed basis.

48. Could the government kindly clarify whether the Principal Investigator for this contract should be included in paragraph 5) Necessary Personnel on page 75 of the RFP?

Response: The Principal Investigator shall be included in personnel proposed.

49. Other than Data Management Plan templates, could the government kindly provide examples of the specific types of "study materials" templates requested on page 81 of the RFP that should be included in the proposal submission?

Response: Examples of these reports would be; safety reports and all standard and study specific reports. The specifics of each report would be discussed in detail with the study team prior to awardee issuing the Data Management plan.

50. Could the government kindly clarify whether randomization is required as part of the EDC system functionality? Randomization is noted in Section 3.G.3 and 3.H.1 of the RFP. Please clarify.

Response: Yes, randomization will be required.

51. In section G. Data Management number 8, could the government kindly clarify whether the referenced provision of study/trial-specific "project management plans" should refer to data management plans?

Response: Yes, the project management plans refers to data management plans.

52. Since a study clinical monitoring strategy impacts CDMS, how many protocols require 100% source data verification approach for clinical monitoring? How many protocols will use risk-based monitoring approach?

Response: This answer is unknown, there are many factors that contribute to the approach.

53. What countries/regions of the world are international sites expected to be located in?

Response: This will be determined by protocol requirements. VRC is currently working with sites in Africa, Central and South America and the Caribbean.

54. What type(s) of documents will need to be translated and into what languages?

Response: This will be determined by protocol requirements. Examples of items needing translation: essential regulatory documents, source documents and eCRFs.

55. Are site initiation visits expected to only be for training purposes? If not, what other activities will the contractor be responsible for during these visits?

Response: Assume site initiation visits are expected to be for training purposes only.

56. If a new contractor support team is selected, will the government continue to run the legacy data warehouse in parallel for the remainder of any ongoing studies?

Response: No, there will be a 2-month transition period in which data will be moved to the new system.

57. Does the government have an estimate for the level-of-effort anticipated for Professional, Other

Professional, and Support services?

Response: Offeror should propose necessary personnel to fulfill the RFP requirements.

58. Due to the international nature of the studies, would NIH permit a global center (Non-U.S.

based) that can be set-up to provide 24x7 support on the following – Technology support, help desk, training support, etc?

Response: Offeror should propose what they feel is the best fit for the government.