TBTC_35_Questions_and_Answers_Final_080219_revised.pdf

TBTC 35 Questions and Answers

RFQ 75D301-19-Q-70517

Item # Question Answer

1 Is there an incumbent on this project. If so who is the incumbent ?

This is the first time this acquisition has been completed through a contract.

2 Per page 28 of RFQ, key personnel is blank. Does CDC have any specific key personnel for this project

This is for the offeror to list any of their key personnel.

3 Is there a minimum number of Past Performance Survey expected to the sent ?

No.

4 Please clarify the total number of sites for on-site monitoring visits.

Page 7 of 66 of the RFQ, Section C.7 PLACE OF

PERFORMANCE includes Contractor’s Facility and Stellenbosch

University; Cape Town, Republic of South Africa (RSA).

Stellenbosch is comprised of three sites: Desmond Tutu Center;

Brooklyn Chest Hospital; and KIDCRU. Appendix B_S35

Summary, Page 2 under Sites, states the sites are TBTC Site 33, Desmond Tutu TB Centre, Stellenbosch University, and TBTC Site

34, Baragwaneth, Perinatal HIV Research Unit (PHRU), Wits

Health Consortium, Soweto, Johannesburg, South Africa. Is the total number of sites for on-site monitoring visits four, three in

Cape Town (Stellenbosch) and one in Johannesburg (PHRU)?

Yes. There are two sites in Cape Town, at Desmond Tutu

Centre and KIDCRU/FAMCRU; and PHRU in Johannesburg.

There are three sites total.

There is one PK lab in Cape Town, and one safety lab in

Johannesburg.

5 Please clarify the expectation for monitoring directly observed therapy. Page 5 of 66 of the RFQ, Section C4 TASKS TO BE

PERFORMED, b. Visit Types, 2. Periodic Visits iv. and Page 6 of

66 of the RFQ, e. Pharmacy Visit, 2. both reference “Directly observed therapy observation.” Is the expectation the CRA monitor will verify documentation that the site staff utilized directly observed therapy, OR is the expectation the CRA directly observe a participant receiving directly observed therapy plus verify documentation that the site staff directly observed therapy. If the expectation is for the CRA to observe the participant receiving directly observed therapy, how many participants should be observed?

The expectation is that the CRO (what you refer to as CRA) will directly observe a participant receiving therapy plus verify documentation. At least one participant should be observed at each periodic visit when participants are receiving therapy. If there are scheduling constraints prohibiting observation of therapy, it is acceptable if only one participant is observed receiving therapy for the duration of the study.

6 Please clarify the expectation for the conduct of laboratory compliance visits. Page 4 of 66 of the RFQ, Section C.2.

PURPOSE, first paragraph last sentence states that on site monitoring will include laboratory compliance visits. Also, Page 6 of 66 of the RFQ, e. Pharmacy Visit, 3. Includes a “PK laboratory visit – observation and monitoring to ensure compliance with study procedures.”

a. Are the laboratory compliance visit and PK laboratory visit the same visit type?

b. Is the expectation that the CRA will verify site documentation of PK specimen collection and laboratory processing, OR is the expectation that the

CRA directly observe PK specimen collection and processing plus verify documentation of site staff

PK specimen collection and processing?

c. Is it expected the laboratory compliance visit will be conducted by a laboratory specialist or a CRA site monitor with laboratory training?

a. Laboratory compliance and PK laboratory visits are not the same. This study will have both a PK laboratory and laboratory processing safety bloods, pharmacogenomic samples, and mycobacteriology samples.

b. The expectation is that the CRO (what you refer to as

CRA) will observe PK specimen collection and processing and verify documentation of site staff PK specimen collection and processing.

c. There is no expectation of whether the laboratory visit will be conducted by a laboratory specialist or CRO

(what you refer to as CRA) with laboratory training.

The expectation is that the person performing the visit is knowledgeable of laboratory practices. We are not specifying who that person needs to be.

7 Are the monitoring activities listed in the RFP covered by clinical trial insurance or does the government anticipate that the contractor will procure clinical trial insurance to adequately cover the activities listed in the RFP?

The government does not have clinical trial insurance for the trial, but the clinical research sites may have coverage for their site. The government does not expect the contractor to procure clinical trial insurance.

8 Will either the Sponsor or the study drug manufacturer maintain product liability insurance that will provide indemnification for the company that receives this award in the event study subjects are injured or incur medical expenses due to their participation in the study?

a. If the neither the Sponsor or manufacturer will provide this indemnification insurance as they normally do, may offerors include the direct cost of obtaining such insurance as part of our cost proposals? If not, please explain why?

No, the sponsor or the study drug manufacturer will not maintain product liability insurance that will provide indemnification for the company that receives this award.

The government does not expect the offerors to include liability insurance as a direct cost.

9 Could the Government clarify how much of the monitoring activity and travel will occur in the base period, as well as the option period?

The table below lists visits per year. The same number of visits will occur in both years of the study. The maximum number of expected visits is 26.

Type of visit Base Year Option

Year 1

Comment

Pharmacy 3 3 One per each site

PK lab 1 1 In Cape Town

Safety lab 1 1 In

Johannesburg

Periodic-

DTTC

3 3

Periodic-

FAMCRU

2 2

Periodic-

PHRU

10 The instructions in “C. Quote Part II – Price” on page 65 of the

RFQ state as follows: “The Offeror must complete a Pricing Table giving a detailed cost breakdown of the total cost or NTE amount by task or labor categories, labor hours, and labor rates used, and then calculating the total amount for the base period and each option period. A price analysis of the quote will be conducted to determine the reasonableness of the Contractor’s price quote.” The

RFQ requests FFP pricing for CLINs 0001 and 1001 and the

Government is seeking commercial item pricing from offerors. If an offeror’s standard commercial pricing practices are based on a unit priced fee for services and not based on labor categories, labor hours and labor rates, please confirm offerors may submit their pricing for the FFP CLINs based on their normal commercial practices and that offerors do not have to provide a cost-type breakdown of labor hours activity and labor rates by labor category?

No. Offerors must submit their pricing per the instructions on page 65 of the RFQ, Section C. titled “Quote Part II- Price”.

11 In the SOW on page 3 of the RFQ it says: “Enrollment is expected to begin in July of 2019 and continue until December of

2020.” Section C.6 Period of Performance on page 7 says the Base

Year will begin on September 1, 2019. Study enrollment can’t begin prior to site initiation visits under this contract, so we believe these dates need revision. Will the Government amend any dates, including those on page 3, listed in the RFQ based on the current expected start date of this contract?

Dates and monitoring activities will be updated accordingly based on the status of the study and the contract award date.

12 Are there any other physical sites/locations besides the 3 mentioned

(i.e. satellite locations) to be involved in the study?

No, all the physical sites/locations were listed in the RFQ

13 It has been noted that Desmond TUTU TB centre and KIDCRU are both located in the Tygerberg hospital. As they have been listed as separate sites, should we assume that they are in different physical locations and have access to different patient populations?

Yes. The clinical center for DTTC is at Brooklyn Chest

Hospital. The clinical center for KIDCRU/FAMCRU is at

Tygerberg hospital. Recruitment areas and target populations differ for the two sites.

14 Can the sponsor confirm the status of the regulatory and ethics submissions? Specifically, when are the full approvals expected?

Can updated study timelines be provided?

All regulatory approvals are in place. Study timelines will be provided and discussed upon contract award.

15 Can the total number of CRF pages per subject be provided? Are there any additional diaries or other data collection tools to be used?

There are 24 case report forms (CRFs) for this study. Total pages is estimated to be 100. Please note that all CRFs, except the Screening form, are electronic for this study. Additionally, each participant can have multiples of some CRFs, so participants will have more than 24 CRFs in their charts.

Sites may maintain screening logs separate from CRFs.

The pharmacy will also have separate accountability and tracking tools.

16 Is there a more up to date protocol available for us to review, which includes a schedule of activities, inclusion/exclusion criteria, etc.?

The protocol is proprietary information and cannot be shared with the public. The protocol will be shared with the awardee after the appropriate non-disclosure agreements are signed.

17 What Trial Master File (TMF) system will be used? Is the CDC’s

TMF paper or electronic?

The TMF is maintained electronically, but the awardee will not have access to the file. The government will provide the awardee with any files that are needed. The awardee will have access to the files at the research sites.

18 Can CDC confirm the estimated number of CRFs that will be part of the study case book?

There are 24 unique CRFs for this study. Please note that the

CRFs are organized into event- and data-specific forms, so participants will have more than 24 CRFs in their charts.

19 There appears to be a discrepancy in the anticipated clinical sites that are noted RFQ “Place of Performance” (Page 7 of 66) and the

Protocol Summary (Page 2). Can CDC confirm which clinical sites may be participating in this study?

See response to question #4.

20 Are there any restrictions on using our affiliate staff located in

India to perform this work?

We do not understand this question as it relates to a specific requirement or section in the RFQ.

The purpose of the Q&A is to provide clarity in areas in the

RFQ, not to address whether minimum qualifications or any other evaluation criteria are met.

21 Page 64 states “Minimum Qualification” states “At least 5 years of experience in the last 10 years performing on-site monitoring for clinical research sites in South Africa conducting pharmacokinetic trials in children”.

a. We have performed on site clinical monitoring at clinical research sites in South Africa and conducted pharmacokinetic trials in children; however, the children’s pharmacokinetic trial monitoring was completed in countries other than South Africa.

Would this experience meet the minimum qualification?

This question is asking the government to confirm whether you meet the minimum qualification. This determination will be made in the evaluation process.

The purpose of the Q&A is to provide clarity in areas in the

RFQ, not to address whether minimum qualifications or any other evaluation criteria are met.

22 Would the government consider evaluating vendor past performance based on CPARS in lieu of the questionnaires?

No.

23 Could you please tell me if this is a new requirement, or if there is a current or previous contractor who has performed similar services?

See answer to question #1.

If available, can you please send along the incumbent contract or task order number?