Clinical_Monitoring_Q_and_A_NIHAO2017058_12-22-16.pdf

Reference Page Question Section E 92 1. Please confirm whether the HIV Antiviral Treatment trials requirement is applicable to this RFP

This is not applicable for the monitoring contract.

Attachment 03: Base Contract Statement of Work

2. Does full clinical monitoring include 100% source data verification?

Answer If you are asking if 100% source data verification has to be done for each trial monitored the answer is "No". Historically, VRC's monitoring has been somewhat risk based monitoring.

Attachment 03: Base Contract Statement of Work

3. Approximately how many protocols per year will require monitoring?

Answer This will be dependent on what products are in the pipeline and what the VRC is asked to respond to in terms issue of public health importance. In general, the Contractor should expect 3-5 protocols requiring monitoring.

Attachment 03: Base Contract Statement of Work

4. 1.3 References monitoring visits to "domestic and international clinical sites." Are these already identified, if so which countries and states?

Answer No Section M - Item 4 5. Please confirm whether the Human Subjects Evaluation within Section M is required for this submission?

This is not required for the monitoring contract.

Section L - Item 2.a.2/Attachment 01 55 6. Section L mentions double-sided printing and paper type. Please confirm that this is an electronic submission requirement as referenced in Attachment 01 Answer This is not applicable because of electronic submission requirements.

Attachment 03: Base Contract Statement of Work

7. For budgeting purposes how many sites should be included in the budget and in what cities?

Answer For budgeting purposes utilize 10 sites - 5 sites in US cities and 5 sites outside the US. The offeror can pick the city and country (ies).

Attachment 03: Base Contract Statement of Work

8. Should we include any risk-based monitoring?

Answer Yes Attachment 03: Base Contract Statement of Work - Section A2 iii

9. Who will determine if "specialized" or "for-cause site visits" need to be conducted and should we budget for these? If yes, how many should be included in the budget?

How many days should we plan on? In what location?

Answer VRC as the Sponsor will request "specialized" or "for-cause site" visits or the monitoring or site management team can provide recommendations based on findings during visits or upon review of reports.

Attachment 03: Base Contract Statement of Work

10. Who will be maintaining the Trial Master File?

Answer The Contractor may collect or upload items that will be part of the TMF but the Contractor awarded the complementary contract will be responsibile for compiling and maintaining the documents prior to transfer to the VRC as the Sponsor.

Attachment 03: Base Contract Statement of Work - Section A3 i

11. Will all sites require a site assessment (pre-study) visit or can visits be waived if the site is known to the sponsor or the CRO?

Answer Site assessments can be waived by the Sponsor.

Attachment 03: Base Contract Statement of Work - Section A3 iii and Attachment 08 Additional business proposal instructions Section 3.2.c

12. How many days should be budgeted for the Site initiation visits?

Answer That will depend on variables such as site location, study team experience and the protocol complexity.

Attachment 03: Base Contract Statement of Work - Section A3 v

13. Are Specialized Pharmacy Visits separate from the routine/interim visits and if so how many per site/study? How many days?

Answer Pharmacy visits should occur during routine and interim visits.

Attachment 03: Base Contract Statement of Work - Section A3 vi

14. Are Specialized Regulatory Review Visits separate from the routine/interim visits and if so how many per site/study? How many days?

Answer No

Technical Questions - NIHAO2017058 - Clinical Monitoring

Attachment 05: Sample Task Order:

Supplemental: Activities per Protocol Task

15. In order to provide source documents will the CRO have access the CRFs created for the study?

Answer In general, the VRC team creates the source documents and the Contractor would assist with formatting. Additionally, the source are most often created before the eCRF is available.

Attachment 05: Sample Task Order:

Supplemental: Activities per Protocol Task

16. Approximately how many CRF pages will be included in the sample protocol

Answer Please provide assumptions based on the study schedule of evaluations and subjects to be enrolled.

Attachment 05: Sample Task Order:

Supplemental: Activities per Protocol Task

17. Is the data management piece part of this RFP?

Answer No. VRC has a separate contract for Data Mgmt services.

Attachment 03: Base Contract Statement of Work

18. Will there be an investigators meeting and if so how many days should be planned for and in what location?

Answer Structure, content, allotted time/days and location for investigator meetings will be decided based on the protocol and PI experience.

Attachment 03: Base Contract Statement of Work

19. Will there be a central IRB (CIRB)? Will this be the responsibility of the CRO to implement?

Answer Yes and no the CRO will not be responsible for implementation Attachment 03: Base Contract Statement of Work

20. Who will be responsible for filing Safety Reports to the sites, the CIRB and FDA if required?

Answer The site and contractor provide site mgmt will be responsible for filing Safety Reports for their specific site. VRC will fill reports to CIRB and FDA support from the complementary contract will be utilize to draft reports on a case by case basis.

Attachment 03: Base Contract Statement of Work - Section 3

21. Task Order Requirements A.1.vi.k: Who will be responsible for obtaining and shipping the vaccine to the sites?

Answer These activities will be covered under the complementary RFP solicitation NIHAO2017059.

Attachment 03: Base Contract Statement of Work - Section A4i

22. Please provide the detailed information regarding the CDMS and vendor providing the CDMS. This information can not be found in the Technical Proposal Instructions as referenced under Attachment 03 section 4i.

Answer EMMES Corporation is the Contractor providing the CDMS

Attachment 03: Base Contract Statement of Work - Section B, D1ia1, and D1ib2

23. Please clarify the Key Personnel role for "Program Manager//Project Manager" is the same as the Project Manager noted under D1ib2 and confirm that the "Project Director" noted under D1ia1 is not a Key Personnel role.

Answer Confirmed

Attachment 01: Packaging and Delivery

24. Please confirm that Attachment 01 should reference "Clinical Trial Monitoring Initiative" and not "General Clinical Research Support Services" as noted in the title. The Solicitation number appears to be correct

Answer Confirmed General Question 25. How many active studies does the VRC anticipate will require concurrent monitoring support?

Answer 2 TO 4 General Question 26. Will subject injury costs be allowable under the awarded contracts?

Answer The Government does not provide subject indemnification. However, site may chose to purchase insurance at their cost.

General Question

27. Does NIAID anticipate contractors will access government facilities or IT systems as part of awarded services? Will such information and requisite security clearances be referenced in TORFPs?

Answer YES if needed.

SOW 3.A.1.vi.d

28. Would the Site Monitoring Contractor be required to do more than ensure timely reporting to sponsor (NIAID), e.g., be involved in processing and/or tracking of protocol violation and deviations?

Answer If the contractor has a method or provides support for theexample provided, VRC would be interested in reviewing that in the proposal. Processing, tracking and categorizing violations and deviations would be of great benefit to mitigating risk and the resolution process.

SOW 3.A.1.vi.f 29. To prevent misinterpretations of SOW 3.A.1.vi.f, could the Government please provide VRC’s definition of “protocol exemptions”?

Answer In general protocol exemptions are situations where eligibility criteria or other aspects of the protocol need to be excused in order to enroll or follow a subject. VRC has not done protocol exemptions. In the case where eligibility criteria or other aspects of the protocol affect the study process and the issue is not safety related, VRC would amend the protocol and proceed with all required regulatory reviews

SOW 3.B

30. There is an inconsistency between Personnel requirements and Project Management requirements. In SOW 3.B. Scientific and Technical Personnel under Key Personnel there is a requirement for a Program Manager/Project Manager, while in D.1.i.a and D.1.i.b both a Project Director and a Project Manager are requested (i.e., as separate individuals). Please clarify if VRC expects one or two individuals for these positions

Answer The Contractor should decide is the activities required can be fulfilled by one person performing both roles or two people with separate roles.

SOW Section D.1(ii) – Project Management 31. Project Management. Can the VRC provide the typical regions (US) and countries (OCONUS) used for VRC protocols?

Answer No, to date we have utilized sites across the US many have been Vaccine Trial Units (VTU) and/or HIV Vaccine Trial Units (HVTU). VRC currently is utilizing a site at Upenn, UMD and Emory for two separate protocols and six sites in the Carribbean for a multi-site study. We have collaborated with the military to active sites in several African countries. Regions in the US and specific countries will be based on such items as the protocol, infectious agent and public health needs.

SOW Section 4 of Attachment 3

32. Section 4 of Attachment 3 notes “the contractor shall utilize the web based CDMS for review of trial data entered as electronic case report forms (eCRF’s) for each clinical trial” and then notes to “(See additional Technical Proposal Instructions for specifications of the system)”. However, the specifications of the CDMS are not included in the Additional Technical Proposal Instructions. Can VRC please provide, as this is important for adequate staff selection and training planning?

Answer The information in the additional tech proposal instructions provides IT specifications needed for the system. The system is a sequel server web-based data system. All eCRF will be provided for each protocol via the data system. Training will be provided to Contractor Team and subs at no cost to the Contractor.

Sample Task Order

33. Does the VRC wish for offerors to provide a technical response and estimated cost for all contractor activities delineated in the responsibility matrix in the Sample Task Order, or only those activities under clinical monitoring (Task 17)?

Answer Clinical Monitoring activities only. Also, to clarify, the Supplemental: Activities per Protocol page was designed to give the offeror a general idea of how the roles are divided and the complementary nature in which tasks are employed to complete the work.

Sample Task Order 34. Does the VRC have a specific location/site proposed/required for the Phase I trial or should the offeror propose a location?

Answer Offeror should propose a location

Sample Task Order

35. Attachment 05 (Sample Task Order); SOW. II.A states that “The protocol and schedule of evaluations will be provided to facilitate development of the clinical monitoring plan.” Since there is no additional information in this RFP, should we use the Phase I part of the Clinical Trial information provided in RFP NIHAO2017059, or can the Government provide a protocol synopsis?

Answer A Precis and Schedule of Evaluations will be uploaded and/or you may refer the Precis and SOE listed in the Clinical Research solicitation which is the same. The current Sample TO list Part 1 of the study plan on the Precis, please provide responses for Part 1 and Part 2 of the uploaded documents

Sample Task Order

36. Please provide clarification on the timelines (if possible first subject randomized, last subject randomized, last subject out) and whether the 9 visits include the screening or not.

Answer Subjects should assume 3-6 month for screening and enrollment and 1 of the 9 visits can be used as a screening visit.

Attachment 5 Task Order, Appendix A

37. Attachment 5 Task Order, Appendix A, Study Plan part 1 is a 20-subject study. Attachment 8 instructs offerers to price out the Task Order over 7 years. Would you please clarify the duration of Part 1 of the study?

Answer See Response to Question#35. The duration of Part 1 and 2 is approximately 2 years based on 2-6 month screening and enrollment.

Sample Task Order

38. In the task order, approximately 6 visits are planned for the 20 participants at 1 site. The assumed level of effort far exceeds this level of monitoring activity even in the first year. Pricing can be done off of the SOW or off of the assumptions for level of effort, please advise.

Answer I am not sure where it is written about the 6 visits. Please see response to Question#35 and pricing should be based off the SOW.

Sample Task Order

39. In the “Supplemental: Activities per Protocol” for the task order, Number 6 - “Site Initiation Visit” is in blue but is listed as a responsibility for the monitoring RFP as well.

Which contract is the lead for this activity?

Answer The Clinical Research Trial Support Contract will be the lead.

Attachment 03

40. Should we assume that all the tasks listed under Clinical site monitoring in Attachment 03, part 1 GENERAL TASK ORDER REQUIREMENTS A.CLINICAL MONITORING, are included in the sample Task Order Scope of Work (SOW), even though they are not specifically listed in Attachment 05? OR, is the sample Task Order SOW limited to site initiation, interim monitoring and close out, plus a clinical monitoring plan?

Answer The later.

Sample Task Order

41. Please supply more details about the sample task order, for example:

a. What is the location of the site(s)?

b. What is the patient selection criteria?

c. What is the schedule of the 9 evaluation visits?

d. What is the timeline for the study activities?

These can be answered from the uploaded précis and schedule of evaluations.

N/A 42. Is there an education requirement for the Program Manager, Project Manager or Lead Clinical Associate?

Answer No, however, personnel performing these roles should have the education and experience to allow performance of the duties effectively, efficiently and at full capacity.

Personnel descriptions and CV's should have pertinent and accurate information to provides ample evidence that the duties can be performed.

N/A 43. Will contractor be required to Provide staff to administer vaccines to subjects?

Answer No, this is a reqirement for the Conractor(s) awarded under the clinical research trial support RFP.

N/A 44. Has a PI been selected for the clinical trial and if not is the contractor required to furnish one?

Answer Not sure if this is in reference to the Sample Task Order or for the Contract. If this is for the contract, no PI has been selected. Site PI's will be selected during site selection and the lead for the activity with be VRC as the Sponsor and the Contractor under the complementary solicitation (Clinical Research Support Services)

N/A

45. Is the contractor required to process, test, and store the subject samples? This includes phlebotomy, sample processing, quantifying viral load if necessary, statistical analysis of results, etc.

Answer No, this is a reqirement for the Conractor(s) awarded under the clinical research trial support RFP.

N/A 46. Are there any geographical requirements for clinical trial sites?

Answer No

N/A

47. The RFP states that The Intent to Bid response sheet is to be submitted with the proposal. Is there also the expectation that it should be submitted with the questions tomorrow as well or only with the submission of the final proposal?

Answer Intent to Bid sheets may be provided submitted before the proposal due date or with the submission of final proposals

Attachment 06: Task Order Reporting Requirements and Deliverables - General Clinical Research Support Services NIHAO2016053

1. Please confirm that Attachment 06 is relevant to another solicitation and not to this solicitation and please provide the Attachment 06 that reflects the general task order reporting requirements and deliverables for this solicitation

Answer Attachment 06 is not relevant. Please disregard.

Page 50 and Attachment 5 50

2. On Page 50, the RFP states this solicitation will have a seven year ordering period, but the sample task order didn’t provide the anticipated period of performance. For budget purposes, how long is the period of performance of the sample task order? Should we use 7 years?

Answer The ordering period will be determined by the activity required. For example, if the task order is for protocol implementation, then the anticipated period of performance will be for the duration of the protocol schedule of evaluation plus the time necessary to get items in place to start as well as time at the end for close out. Task Orders may have a max period of performance up to five (5) years

Attachment 8 3. Is the Level of Effort table found in Attachment 8- Section 3, assumed for each task order?

Answer This is not for the entire Contract but just is a guide.

N/A 4. The number of awards is not denoted. Can the Government confirm the number of anticipated awards?

Answer The government cannot state the number of awards at this time.

N/A 5. Please confirm that the offeror is not required to address any of the requirements of section M.4. Human Subject Evaluation.

Answer This is not required for the monitoring contract.

N/A 6. Please confirm that the offeror is not required to address the requirements of sections M.6. Evaluation of Data Sharing Plan and M.7. Evaluation of Data Sharing Plan Answer This is not required for the monitoring contract.

N/A

7. Please confirm that Attachment 6 does not apply to this RFP, i.e., that it was included in error. (E.g., it references the solicitation, General Clinical Research Support Services)

Answer This is not required for the monitoring contract.

N/A

8. Please confirm that both the Clinical Site Monitoring Contractor (NIHAO2017058) and the Clinical Research Support Contractor (NIHAO2017059) will be conducting Site Assessment Visits.

And, if your answer is ‘Yes’ and the Monitoring Contractor will be doing them (as per SOW3.A.3.i.), should we include this visit in our budget with a UAC of 1 site assessment visit?

Answer This will be protocol dependent and based on the scale of trial being implemented. However, for budgeting purposes please include 1 assessment visit.

N/A 9. In addition to providing costs for the Sample Task Order, should the offeror also provide costs for the base contract year and each option year?

Answer Yes, the contractor shall provide separate costs for the IDIQ contract as well as the task order and any option years that may be necessary. Please note the IDIQ contract will not have option years only the individual task order may have option years based on the study N/A 10. Are the Uniform Cost Assumptions noted in Section 3 to be used for the pricing of the Sample Task Order, or for the base contract year and each option year?

Answer The Cost Assumptions shall be used for the Sample Task Order as well as the IDIQ Contract. Please note the IDIQ contract will not have option years only the individual task order may have option years based on the study N/A 11. Many of the UCA’s noted in Section 3 are dependent on the number of active protocols. Can VRC provide an estimate on the number of active protocols annually?

Answer Two (2) to four (4)

N/A

12. Does the VRC have specific location(s)/site(s) proposed for the Visits in the Technical Cost Assumptions, or should the offeror propose a location(s)? (E.g., should it be the same location as the Sample Task?)

Answer If this question is referring to the Sample Task Order, please propose a location and provide budget proposal based on that. If this question is for the contract as a whole, locations will be based on protocol requirements and public health needs.

N/A 13. Please confirm Section 6 is an error as it is duplicative of Section 5.

Answer Section 6 is an error as it is duplicative of Section 5.

N/A

14. A different solicitation number is referenced in the header of Attachment 06 (NIHAO2016053), while the solicitation number in Section A is NIHAO2017058. Please clarify the solicitation numbers

Answer Please disregard NIAO2016053 as it was a typo and is not relevant to this solicitation

Business Questions - NIHAO2017058 - Clinical Monitoring