75D301-20-Q-71779 00001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

1 58

2. AMENDMENT/MODIFICATION NO.

00001

3. EFFECTIVE DATE

07/02/2020

4. REQUISITION/PURCHASE REQ. NO.

00HCVJEE-2020-42747

5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 2543 7. ADMINISTERED BY (If other than Item 6) CODE

Centers for Disease Control and Prevention

Office of Acquisition Services (OAS)

2900 Woodcock Blvd

Atlanta, GA 30341-5539

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

X

9A. AMENDMENT OF SOLICITATION NO.

75D301-20-Q-71779

9B. DATED (See Item 11)

07/02/2020

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers x is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEGMENT

TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT

IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, X is required to sign this document and return 1 copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

1. See Continuation Page for Details..

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME OF CONTRACTING OFFICER

Candice L. Simmons

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

July 2, 2020

NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GSA

FAR (48 CFR) 53.243

ITEM 10A.

Contract No. 75D301-20-Q-71779

CONTINUATION PAGE

Amendment 00001 to Request for Proposal 75D301-Q-71779 is being issued to do the following:

1. Provide all interested offerors with answers to questions (Attachment D.7 – Questions and Answers) submitted on or before June 25, 2020 as required per originally posted solicitation.

See attachment titled “Amendment 00001 – Questions and Answers”.

2. Incorporate revised Section B titled “CONTINUATION CONTINUATION OF SF1449” with the following changes:

a. Change Unit Price to Not to Exceed (underlined and bolded).

b. Revised Travel Plug Number verbiage under CLINs 0002, 1002, 2002, 3002, and 4002 (underlined and bolded).

3. Incorporate revised section B.2 titled “Suggested Labor Categories per Year” with the following change(s):

a. Incorporate revised B.2 “Suggested Labor and Labor Categories and Estimated Level of Effort Chart”

b. Revise verbiage at C. under Senior CRA as follows:

FROM: Involved in the development of protocols and Case Report Forms (CRFs) as assigned.

TO: Involved in the review and input of protocols and Case Report Forms (CRFs) assigned.

c. Revise verbiage at C. under Data Analyst as follows:

FROM: Design, Implement and Maintain complex data systems and databases.

TO: Maintain complex data systems and databases.

4. Incorporate revised Performance Work Statement (PWS) Section 3 titled “Scope of Work” with the following change:

a. Revise language to illustrate the acceptability of On-site or remote visits for periodic monitoring (all changes underlined and bolded).

b. Revise language to illustrate provision of monitoring services to existing Study 37 and future studies to be developed (all changes underlined and bolded).

5. Incorporate revised Performance Work Statement (PWS) Section 4 titled “Tasks to be Performed” with the following changes:

a. Change “Task 4.1 – Planning, Pre-Study, and TBTC-Specific Activities” to “Tasks 4.1 – Planning, Pre-Study, and TBTC-Specific Activities”. Renumber bullets under Tasks 4.1. (all changes underlined and bolded)

b. Change “Task 2-TBTC Clinical Site Management and Monitoring” to “Tasks 4.2-TBTC Clinical Site Management and Monitoring”. Renumber bullets under Tasks 4.2. (all changes underlined and bolded).

c. Change “Task 3 -Reporting to Sponsor” to “Tasks 4.3-Reporting to Sponsor”. Renumber bullets under Tasks 4.3. (all changes underlined and bolded).

d. Change “Task 4-Internal Quality Assurance and Audits” to “Tasks 4.4-Internal Quality Assurance and Audits”. Renumber bullets under Tasks 4.4. (all changes underlined and bolded).

e. Change “Task 5-Investigational Product Management” to “Tasks 4.5-Investigational Product Management”. Renumber bullets under Tasks 4.5. (all changes underlined and bolded).

f. Revise 4.2.15 under Tasks 4.2 as follows:

FROM: Utilize and existing clinical trial management system that includes real-time data entry and central monitoring tools.

TO: Utilize CDC’s existing clinical trial management system, TBTC2, which includes real-time data entry and central monitoring tools (changes underlined and bolded).

6. Incorporate revised Performance Work Statement (PWS) Section 6 titled “Period of Performance” with the following change:

a. Incorporate verbiage that advises offerors to “Use the maximum number of estimated studies for each year of the overall period of performance when developing both their business and technical proposals” (all changes underlined and bolded).

7. Incorporate revised Performance Work Statement (PWS) Section 9 titled “Place of Performance” with the following change:

a. Change verbiage as follows:

FROM: Awarded TBTC Vendor’s business location and seven (7) to twelve (12) clinical research sites within the United States and Canada, and three (3) to five (5) international sites in countries of high TB prevalence and incidence (total number of sites 10-17). Total number of awards variable because some contracts may include multiple clinical sites to be determined. TBTC Monitoring services will be required at these locations as well as the offeror’s place of business.

TO: Awarded TBTC Vendor’s business location and seven (7) to twelve (12) clinical research sites within the United States and Canada, and three (3) to five (5) international sites in countries of high TB prevalence and incidence (total number of sites 10-17). Some awarded TBTC Vendors may include multiple clinical sites. TBTC Monitoring services will be required at these locations as well as the offeror’s place of business. (all changes underlined and bolded).

8. Incorporate revised number three (3) titled “TECHNICAL PROPOSAL INSTRUCTIONS” under

Section 12 titled “Instructions, Conditions, And Notices to Offerors” with the following changes (changes underlined and bolded):

a. Revise verbiage at 3(f) as follows:

FROM: Electronic Proposal submissions must be addressed to the attention of Mrs.

Candice L. Simmons and submitted as well as received at iie3@cdc.gov no later than 3:00 PM EST on 07/15/2020.

TO: Electronic Proposal submissions must be addressed to the attention of Mrs. Candice L. Simmons and submitted as well as received at iie3@cdc.gov no later than 3:00 PM EST on 07/17/2020.

9. Incorporate revised number four (4) titled “TECHNICAL PROPOSAL INSTRUCTIONS” under

(changes underlined and bolded):

a. Add requirement to include/submit Signed Consent (Attachment D.5) in TAB B per 4(b)(2).

b. Delete 4(b)(5) TAB E requirement to submit Subcontracting Plan (Attachment D.4) as part of the Technical Proposal (Volume I).

c. Revise 4(c ) verbiage to do the following: (1) Remove reference to TAB E (2) Remove requirement to submit cross reference between the RFP and technical proposal, and (3) Remove/Exclude Past Performance response from 30-page Technical Response limit.

d. Revise 4(d) to remove TABs D and E.

e. Revise 4(d)(2)i. to clarify that Key Personnel are the Project Manager and Senior Clinical

Research Associate (CRA).

f. Revise title at 4(d)(5) to clarify association with TAB D.

g. Revise 4(d)(5)B as follows:

i. Add verbiage regarding the need to not submit Past Performance Surveys for contracts whereas the period of performance has concluded and all Contractor Performance Assessment Reporting System (CPARS) evaluations have been completed and are readily available/retrievable by the Office of Acquisition Services.

ii. Add verbiage clarifying that signed consent forms (Attachment D.5) are to be submitted as an Appendix under TAB B.

h. Remove 4(d)(6) titled “Subcontracting Plan (This section applied to domestic entities only)” as a submission requirement associated with offeror’s Technical Proposal (Volume I).

10. Incorporate revised number five (5) titled “Business Proposal Instructions (Apr 2000)” under

(changes underlined and bolded):

a. Make revisions under introductory paragraph as follows:

i. Revise (2) as follows:

FROM: The completed Section B TO: The completed Section B and Detailed Pricing Information

ii. Add number five (5) “Other Administrative Data”

iii. Add number six (6) Sub-Contracting Plan (Attachment D.4)

b. Revised verbiage under 5(2) titled “The completed Section B and Detailed Pricing information” as follows:

FROM: You must submit, as a minimum, a business proposal supported by detailed pricing information. The offeror should propose Travel, Other Direct Costs, or other ODCs that apply.

TO: You must submit, as a minimum, a business proposal supported by detailed pricing information inclusive of completed Section B (Inclusive of CLINs, B.1 “Recapitulation Table, and B.2 “Suggested Labor Categories per Year) .

The Offeror should review the RFQ and its requirements and determine what level of effort, labor categories, and skills levels are required to fully complete the requirements based upon the Offeror’s business knowledge and the Offeror’s proposed technical approach.

The offeror should propose Other Direct Costs, including Travel or other ODCs under CLINs 0002, 1002, 2002, 3002, and 4004. Overall proposed costs under each of these CLINs should be comprised of the offeror’s estimated cost for Other Direct Costs and others ODC’s for the associated year of service along with the $10,000.00 Travel Plug Number.

c. Per (5)(4) delete “Suggested Labor Categories and Estimated Level of Effort Tables” along with “Labor Categories/Qualifications” and relocate at section B.2 titled “Suggested Labor Categories per Year”. Add requirement for “Representations and Certifications”, if not current and in the System for Award Management (SAMs), Section C.23 and E.4 (if applicable).

d. Delete CDC100_0004 Data Management Plan (Instructions)(Nov 2018)

e. At (5)(6) add “Subcontracting Plan (This section applies to domestic entities only)”

11. Incorporate revised Section 13 titled “Evaluation Factors for Award” with the following changes

(changes underlined and bolded):

a. Revise verbiage at 13(3) titled “Evaluation of proposals” as follows:

FROM: Offerors proposals will be evaluated in three (3) areas: Technical (Volume I – Contain Technical along with Past Performance and Subcontracting Responses), Past Performance and Price (Volume II).

TO: Offerors proposals will be evaluated in three (3) areas: Technical (Volume I – Contain Technical along with Past Performance Responses), Past Performance and Price (Volume II).

b. Per 13(5) titled “Evaluation of Technical Proposal” remove the Subcontracting Plan from the table titled “Technical Proposal Evaluation Criteria”.

c. Revise title at 13(5)(e) to clarify association with TAB D.

d. Remove (13)(5)(f) in its entirety.

e. Revise verbiage at (13)(6) to clearly articulate requirements association to Volume II.

f. Delete CDC100_0005 Evaluation of the Data Management Plan (DMP)(Nov 2018)

g. At (13)(9) add “Evaluation of Subcontracting Plan Acceptable/Unacceptable”

12. Incorporate revised SECTION D titled “CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS” to add new attachment titled “Attachment D.6 – Study 37”.

13. All other terms and conditions remain unchanged and in full force and effect.

SECTION B - CONTINUATION CONTINUATION OF SF1449

Base Year

ITEM SUPPLIES / SERVICES QTY / UNIT NOT TO EXCEED NOT TO EXCEED

0001 TBTC Study Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs., 3-16 of solicitation).

Base Year (Contract Yr. 1) Period of Performance - September 29, 2020 through September 28, 2021.

This is a Time and Material CLIN.

1 Job $ $

0002 Travel and Other Direct Costs, or ODCs

This is a Cost Reimbursable CLIN. All travel will be reimbursed in accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2020 through September 28, 2021.

1 Job $

$ 10,000.00 Travel Plug Number to be used in developing Price Proposals.

Option 1 Option Year 1 Items:

1001 TBTC Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs., 3-16 of solicitation).

Option Year 1 (Contract Yr. 2) Period of Performance - September 29, 2021 through September 28, 2022.

This is a Time and Material CLIN.

1 Job $ $

1002 Travel and Other Direct Costs, or ODCs

This is a Cost Reimbursable CLIN. All travel will be reimbursed in accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2021 through September 28, 2022.

$ 10,000.00 Travel Plug Number to be

Price Proposals

Option 2 Option Year 2 Items:

2001 TBTC Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs., 3-16 of solicitation).

Option Year 2 (Contract Yr. 3) Period of Performance - September 29, 2022 through September 28, 2023.

This is a Time and Material CLIN.

1 Job $ $

2002 Travel and Other Direct Costs, or ODCs

This is a Cost Reimbursable CLIN. All travel will be reimbursed in accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2022 through September 28, 2023.

$10,000.00 Travel Plug Number to be

Option 3 Option Year 3 Items:

3001 TBTC Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs., 3-16 of solicitation).

Option Year 3 (Contract Yr. 4) Period of Performance - September 29, 2023 through September 28, 2024.

This is a Time and Material CLIN.

1 Job $ $

3002 Travel and Other Direct Costs, or ODCs

This is a Cost Reimbursable CLIN. All travel will be reimbursed in accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2023 through September 28, 2024.

Plug Number to be

Option 4 Option Year 4 Items:

4001 TBTC Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs., 3-16 of solicitation).

Option Year 4 (Contract Yr. 5) Period of Performance - September 29, 2024 through September 17September 28, 2025.

This is a Time and Material CLIN.

Period of Performance - September 29, 2023 through September 28, 2024.

1 Job $ $

4002 Travel and Other Direct Costs, or ODCs

This is a Cost Reimbursable CLIN. All travel will be reimbursed in accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2024 through September 28, 2025.

Plug Number to be

B.2 Suggested Labor Categories per Year - The suggested labor categories are suggestions based on historical data related to similar requirements under the contract. Offerors are not required to use these labor categories or exact amounts/number of hours. They are only provided as an example to the Offeror.

Suggest Labor Categories & Estimated Level of Effort

Historical Data Offeror Proposed

Item Labor Category Hours Rate Estimated Hours

PRICE

Base Year

Contract Manager 200 $ TBD $ TBD

Senior Clinical Research Associate 350 $ TBD $ TBD

Medical Monitor 125 $ TBD $ TBD

Clinical Research Associate (Domestic) 2000 $ TBD $ TBD

Clinical Research Associate (International) 2000 $ TBD $ TBD

Administrative 150 $ TBD $ TBD

Data Analyst 830 $ TBD $ TBD

Technical Writer 100 $ TBD $ TBD

Subtotal for Base Period - CLIN 0001 $ TBD

Option Year One

Contract Manager 200 $ TBD $ TBD

Senior Clinical Research Associate 350 $ TBD $ TBD

Medical Monitor 125 $ TBD $ TBD

Clinical Research Associate (Domestic) 2000 $ TBD $ TBD

Clinical Research Associate (International) 2000 $ TBD $ TBD

Administrative 150 $ TBD $ TBD

Data Analyst 830 $ TBD $ TBD

Subtotal for Option Year One - Subtotal CLIN 1001

Year Two

Contract Manager 200 $ TBD $ TBD

Senior Clinical Research Associate 350 $ TBD $ TBD

Medical Monitor 125 $ TBD $ TBD

Clinical Research Associate (Domestic) 2000 $ TBD $ TBD

Clinical Research Associate (International) 2000 $ TBD $ TBD

Administrative 150 $ TBD $ TBD

Data Analyst 830 $ TBD $ TBD

Technical Writer 100 $ TBD $ TBD

Subtotal for Option Year Two - CLIN 2001 $ TBD

Contract Manager 200 $ TBD $ TBD

Year Three

Senior Clinical Research Associate 350 $ TBD $ TBD

Medical Monitor 125 $ TBD $ TBD

Clinical Research Associate (Domestic) 2000 $ TBD $ TBD

Clinical Research Associate (International) 2000 $ TBD $ TBD

Administrative 150 $ TBD $ TBD

Data Analyst 830 $ TBD $ TBD

Subtotal for Option Year Three - CLIN 3001 $ TBD

Year Four

Contract Manager 200 $ TBD $ TBD

Senior Clinical Research Associate 350 $ TBD $ TBD

Medical Monitor 125 $ TBD $ TBD

Clinical Research Associate (Domestic) 2000 $ TBD $ TBD

Clinical Research Associate (International) 2000 $ TBD $ TBD

Administrative 150 $ TBD $ TBD

Data Analyst 830 $ TBD $ TBD

Technical Writer 100 $ TBD $ TBD

Subtotal for Option Year Four - CLIN 4001 $ TBD

Subtotal for Entire Contract Period of Performance $ TBD

Suggested Labor Categories and Estimated Level of Effort Tables The suggested labor categories are suggestions based on historical data related to similar requirements. Offerors are not required to use these labor categories or exact amounts/number of hours. Offeror should decide labor categories and number of hours proposed based on their developed technical approach. They are only provided as an example to the Offeror.

Labor Categories/Qualifications Contract Manager

A. Managing the Contract lifecycle, including but not limited to: draft, modification, execution, amendments and renewal of Contracts

B. Preparation and review of all contract documentation, including master agreements, statements of work, renewals, amendments, etc.

C. Dissemination of contract documents to the appropriate parties, externally and internally D. Maintenance of a centralized file, storage and documentation system for all contract-related material Senior CRA

A. Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.

B. Involvement in the generation of project plans, especially those related to site management, monitoring and reporting.

C. Involved in the review and input of protocols and Case Report Forms (CRFs) as assigned.

D. Manage the identification, selection and feasibility processes.

E. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.

F. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

G. Ensure the integrity of the data submitted on CRFs or other data collection tools by careful source document review and monitor for missing or implausible data.

H. Prepare accurate and timely trip reports.

I. Organize and make presentations at Investigator Meetings.

J. Interact with internal groups to evaluate needs, resources and timelines.

K. Act as contact for clinical trial supplies and other suppliers as assigned

Medical Monitor

A. Oversee clinical study site management/monitoring activities in compliance with ICH-GCP, sponsor SOPs, local laws & regulations, protocol, site monitoring plan and associated documents.

B. Ensure study patient safety, study protocol development, investigator support, pharmacovigilance and safety data review for sponsors

C. Review final report data and safety review prior to submission to regulatory agencies D. Advise on local and international regulations and requirements needed for clinical studies.

E. Disseminate medical information from sponsor medical team to all study participants and support staff.

CRA Monitor LTBI Study

A. Perform all required activities to ensure appropriate monitoring and management of investigator sites are conducted as per ICH GCP, Ethics and Regulatory requirement and the sites SOPs.

B. Perform all types of monitoring visits: Pre-Study, Study Initiation, Routine/Interim and Close-out visits.

C. Ensured preparation, collection and distribution of trial master file documents and maintenance of investigator site file

D. Perform monitoring visits according to monitoring plan (including trial initiation, training and closeout activities)

E. Complete interim monitoring visits in accordance with relevant SOPs, regulatory requirements and guidelines, the study protocol, project plan and clinical study monitoring plan

CRA Monitor TB Disease Study (International)

A. Perform all required activities to ensure appropriate monitoring and management of investigator sites are conducted as per relevant country GCP, ICH GCP, Ethics and Regulatory requirement and the sites SOPs.

B. Perform all types of monitoring visits: Pre-Study, Study Initiation, Routine/Interim and Close-out visits.

C. Ensured preparation, collection and distribution of trial master file documents and maintenance of investigator site file

D. Perform monitoring visits according to monitoring plan (including trial initiation, training and closeout activities)

E. Complete interim monitoring visits in accordance with relevant SOPs, regulatory requirements and guidelines, the study protocol, project plan and clinical study monitoring plan

Administrative Staff A. Functions as supervisory administrator for program B. Provides administrative supporter of program and project managers C. Oversees workflow and coordinates scheduling of support staff D. Ensures timely receipt and processing of needed management reports and processes, e.g.

expense reports, travel requests, and other reports, including budget and finance.

Data Analyst

A. Maintain complex data systems and databases B. Use statistical tools to interpret data C. Create appropriate documentation D. Prepare reports, supporting documents, diagrams, data, and database specifications to effectively communicate and support program functions, and system modification needs

Technical Writer

A. Document the specifications, design, features and operation of applications B. Write and edit user manuals, help systems and other technical documents C. Design and format documents using document-creation software

There are no clauses/provisions included in this section.

SECTION 3 – SCOPE OF WORK

The scope of this network of monitoring activities may range from small laboratory-based and/or single site studies to large Phase 2 and long-term Phase 3 clinical trials to evaluate new TB drugs and drug regimens, diagnostics, and preventive interventions to ensure clinical trial quality and participant safety, adherence to U.S. and international standards of good clinical practice, data collection and reporting, regulatory compliance, accurate protocol implementation, internal quality management and study product accountability. Monitoring services shall be in support of current study protocol, Study 37 attached as an addendum (attachment titled “Attachment D.6 – Study 37) to this solicitation; and future studies to be developed. As this trial is conducted under IND, has the potential to be audited by US Food & Drug Administration and/or European Medicines Agency. The following will be required:

• On-site initiation visits for all participating sites prior to first enrollment;

• On-site or remote periodic monitoring visits;

• On-site close out visits;

• Tracking of monitoring activities and deficiencies; and

• Reports of monitoring findings.

To support the on-site monitoring, the DCC team will provide:

• Access to and training for the TBTC2 study management system;

• Protocol and case report form training;

• Guidance on protocol implementation;

• Input into study monitoring plan incorporating principles of risk-based monitoring;

• Documentation of obligations transferred from sponsor to CRO;

• Central monitoring of study data and activities;

• Quality assurance of study data; and

• Pre-site visit reports and information prioritizing tasks at on-site visits.

SECTION 4 - Tasks to be Performed

Each vendor as an independent organization and not as an agent of the Government, furnish all the necessary services, qualified personnel, material, equipment, and facilities to conduct monitoring activities for the TBTC clinical trials sites. CRB staff and/or external CRO site monitors will evaluate adherence to U.S. and international standards of good clinical practice (GCP), good clinical laboratory practice (GCLP), data collection and reporting, regulatory compliance, accurate protocol implementation, internal quality management, and test product accountability. Site visits will be performed once or twice yearly, or as-needed to review specific protocols, provide training on protocol conduct, review internal quality assurance plans, and document error resolution.

The expected duration of this contract requirement is five years. For the five-year performance period, the Contractor will focus on the following monitoring tasks:

Tasks 4.1 – Planning, Pre-Study, and TBTC-Specific Activities

4.1.1 Establish an identified project team, including, but not limited to: project manager, clinical trial manager, clinical research associate, regulatory specialist, and quality specialist.

4.1.2 Author, as needed, meeting minutes for all attended TBTC meetings to comply with

Sponsor-established format. Provide meeting minutes to CRB staff within 3 days of meeting.

4.1.3 Author, as needed, internal Standard Operating Procedures (SOPs) associated with processes necessary to comply with the FDA and Sponsor-established requirements.

Provide CRB access to CRO SOPs for review

4.1.4 Develop and maintain study procedure manual(s) and other manuals as necessary, in collaboration with CDC/CRB staff

Tasks 4.2 –TBTC Clinical Site Management and Monitoring

4.2.1 Ensure that the conduct of all trials are in compliance with approved protocol(s), Good

Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Human Subjects

Projection (HSP), and all applicable regulatory and local requirements

4.2.2 Ensure site and IRB/IEC is in compliance with Federal Wide Assurance (FWA), including review of all participant consent forms to assure compliance with applicable regulations

4.2.3 Ensure clinical site staff have documentation of proficiency in: GCP, HSP, and Investigator responsibilities

4.2.4 Organize and provide site training per sponsor request or site-specific needs

4.2.5 In concert with sponsor, develop and implement a robust risk-based monitoring plan with a matrix of study risks, description of risk evaluation, thresholds for action, and quality metric deliverables, which describes visit types and frequencies and activities performed, and presents findings of visits with quantitative measures allowing evaluation of time trends and comparisons among sites

4.2.6 Develop and implement a detailed communication plan outlining communication and issue escalation between vendor, CRB and site staff

4.2.7 Develop and maintain a system to monitor clinical site items that require expiration dates such as site personnel professional licensures, equipment inspections, temperature monitoring or calibration, laboratory license(s), and requisite local regulatory approvals by ethics committees and/or national boards;

4.2.8 Develop and implement clinical site quality management programs including source data validation and quality audits

4.2.9 Develop and implement clinical site quality checks on study personnel performance, and on study specific regulatory and SOP documents

4.2.10 Perform protocol-specific on-site clinical monitoring at site initiation, routine and close-out visits; and at pharmacies and laboratory as applicable

4.2.11 Perform protocol-specific remote monitoring including monitoring participant enrollment and tracking of quality metrics over time

4.2.12 Assist sites with development and maintenance of screening, recruitment, retention, pharmacy, and regulatory compliance/quality management plans

4.2.13 Review site performance on an on-going basis and work directly with site staff to improve processes and achieve best practices

4.2.14 Conduct accountability procedures and coordinate and manage end of study disposition

4.2.15 Utilize CDC’s existing clinical trial management system, TBTC2, which includes real-time data entry and central monitoring tools

Tasks 4.3 – Reporting to Sponsor

4.3.1 The vendor must document findings during or following each on-site monitoring visit with clinical research sites. Specifically, the vendor shall:

4.3.1.1 Communicate with the CRB team immediately if an urgent issue or question arises during an on-site visit. Urgent issues or questions include, but are not limited to, issues preventing the monitor from conducting visit activities and protocol compliance issues that may result in unnecessary harm to study participants.

4.3.1.2 Within 3 business days of completion of visit, send email to the CRB team with high-level, structured summary of visit findings. At a minimum the summary of visit findings should include an overall summary of the monitoring visit, the completion status of activities slated for the visit, and a description of any notable findings and/or deficiencies;

4.3.1.3 Within 10 business days of completion of visit, send a draft monitoring report to CRB team, following agreed upon report format and communication method. At a minimum the draft monitoring report should include the date of the activity and the individual(s) conducting and participating in it; a summary of the data or activities reviewed; a description of any noncompliance, potential noncompliance, data irregularities, or other deficiencies identified; a description of any actions taken, to be taken, or recommended, including the person responsible for completing actions and the anticipated date of completion;

4.3.1.4 Within 30 business days of completion of visit, send a final monitoring report to CRB team, following agreed upon report format and communication method. At a minimum the draft monitoring report should include the date of the activity and the individual(s) conducting and participating in it; a summary of the data or activities reviewed; a description of any noncompliance, potential noncompliance, data irregularities, or other deficiencies identified; a description of any actions taken, to be taken, or recommended, including the person responsible for completing actions and the anticipated date of completion;

4.3.1.5 Within 10 days of monitor’s review of the resolution or corrective action of any deficiencies noted during the monitoring visit, send a monitoring follow-up report. At a minimum the monitoring follow-up report should include the current status of each deficiency, a summary of the issue(s), the resolution or corrective action taken, whether those actions adequately resolved the issue, and whether further follow-up is necessary;

4.3.1.6 Document participant-specific monitoring findings in the TBTC2 study management system at the time of the site visit;

4.3.1.7 Respond to any requests for clarification from summary email or monitoring report within 3 business days of receipt;

4.3.1.8 Maintain a log of findings from site visits. At a minimum the log of findings must address the entry date and current status of each finding, a summary of the issue(s), and the proposed resolution strategy;

4.3.1.9 Communicate with study site teams to document resolution of any findings; and

4.3.1.10 Maintain a log of participant charts reviewed in the CRB-specified format. At a minimum the log of participant charts should address/include the quantity of charts reviewed per site, the identification number of each reviewed chart, specific items reviewed in each chart, and any findings identified.

4.3.2 The Vendor must provide monthly reports of remote monitoring interactions with clinical research sites, including a summary of issues or queries identified, resolved, and not resolved;

and recommendation for training or implementation guidance needed at sites.

4.3.3 The Vendor must provide quarterly high-level, cumulative, summary reports of monitoring findings and pending follow-up log items, with site-specific assessments of study implementation and recommendations for sponsor action.

Tasks 4.4 –Internal Quality Assurance and Audits

4.4.1 Maintain inspection readiness state

4.4.2 Monitor and prepare reports for study Sponsor on progress towards monitoring goals

4.4.3 Develop, implement and maintain an effective internal Quality Assurance, Quality Control and

Audit Plan for all of the vendor’s coordinating and document preparation activities to ensure compliance with federal and local regulations

4.4.4 Utilize an established internal system to measure, monitor and provide feedback on performance of personnel who interact with sites with the goal of continually improving staff performance

Tasks 4.5 – Investigational Product Management

4.5.1 If necessary, identify and establish contractual agreements with clinical research vendors to support studies as needed, including, but not limited to:

4.5.1.1 Develop and implement a study supplies procurement and management plan as well as an Investigational Product Accountability Plan

4.5.1.2 Obtain necessary approvals for import of IP and clinical trial materials including storage and shipment

4.5.1.3 Ensure IP is labeled as investigational, according to IND/IDE requirements

4.5.1.4 Coordinate and manage investigational product shipment, delivery, proper storage, and inventory at clinical sites

Specific contract requirements include the following:

Offerors whose proposal includes a CRO who reside outside of the United States may be accepted.

Listed below are three possible alternatives. While the three ways are shown as alternatives that are only a sample of three different alternatives. Offerors are able to and encouraged to offer different alternatives as they see fit. These three alternatives shown below are in no way meant to infer that these are the only available alternatives and that no other alternatives will be considered. Rather they are meant to be a sample of the available alternatives so as to encourage participation by potential offerors who may otherwise not be able to submit a proposal.

Alternative (1) – the offeror may be a U.S. organization that proposes to sub-contract with an organization outside of the U.S. on behalf of the U.S. government (CDC), with the purpose of providing CRO monitoring support to TBTC Contractors conducting clinical trials for treatment or prevention of TB.

In this instance, the offeror’s proposal will include a sub contractual arrangement with an organization outside of the U.S. The international, sub-contracted organization would be chosen so as to provide efficient access to more experienced, culturally knowledgeable monitors familiar with local site customs than would be available at the organization of a primary offeror. This arrangement will require close coordination between the two organizations.

Under Alternative 1, the U.S organization will provide:

- expertise in clinical trials, in Good Clinical Practice, in Good Laboratory Practice, and in human subject protections, and

- experience in the management of monitoring research contracts with U.S. government agencies (such as the Centers for Disease Control and Prevention), experience in monitoring compliance with regulatory requirements applicable to clinical trials, and experience in sub-contracting procedures.

Alternative (2) – the offeror may be a non-U.S. organization eligible to receive funds (and institute research monitoring activities) directly from (and for) a U.S. government agency. In this instance, the offeror should submit a proposal that is inclusive of all required elements, and the contract would be executed directly and solely with the non-U.S. organization. Non-U.S. (“international”) offerors opting for this approach are expected to be organizations with substantial and well-documented experience in the conduct of monitoring clinical trials, significant experience in monitoring tuberculosis research, significant prior successful experience in receiving and responding to clinical research funding for, and experienced administrative staff familiar with U.S. government contracting procedures.

Alternative (3) – the offeror may be a qualified international organization which elects to obtain supporting services and expertise from a U.S. organization through the mechanism of a subcontract. As in Alternative #2, the offeror must be a non-U.S. organization eligible to receive funds (and institute research activities) directly from (and for) a U.S. government agency. And as in Alternative #2, in this approach, the international organization/ offeror is expected to demonstrate (i) substantial and well-documented experience in the conduct of monitoring clinical trials, (ii) significant experience in monitoring tuberculosis research, (iii) significant prior successful experience in receiving and responding to U.S. clinical research funding, and (iv) the availability of experienced administrative staff familiar with U.S. government contracting procedures. The difference from Alternative #2 is that in this approach, the offeror proposes to obtain some portion of items i-iv through a subcontract with an organization that can provide or strengthen any of these elements. An offeror applying under Alternative #3 must be fully qualified to accomplish administrative aspects of the contract and sub-contract, and should be of sufficient technical strength that it could reasonably be expected to manage its own technical support services.

In each of these 3 alternatives, and any other alternatives that offer may propose, the offeror (with its subcontractors, if any) should demonstrate (a) the availability of significant technical strengths in the implementation of monitoring TB clinical trials, and (b) the availability of all necessary administrative and regulatory expertise to fulfill the requirements and objectives of this contract.

SECTION 6 – PERIOD OF PERFORMANCE

Offeror’s are advised to use the maximum number of estimated studies identified for each year of the contract’s period of performance identified below when developing both business and technical proposals

BASE YEAR:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting; and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-3 new studies may be initiated during this phase.

OPTION YEAR ONE:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting; and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-2 new studies may be initiated during this phase.

OPTION YEAR 3:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting; and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-2 new studies may be initiated during this phase.

OPTION YEAR 4:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting; and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-4 new studies may be initiated during this phase.

OPTION YEAR 5:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting; and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-2 new studies may be initiated during this phase.

SECTION 9 – PLACE OF PERFORMANCE

Awarded TBTC Vendor’s business location and seven (7) to twelve (12) clinical research sites within the United States and Canada, and three (3) to five (5) international sites in countries of high TB prevalence and incidence (total number of sites 10-17). Some awarded TBTC Vendors may include multiple clinical sites. TBTC Monitoring services will be required at these locations as well as the offeror’s place of business.

3. Proposal Format

(a) Your proposal for this acquisition must be prepared in two parts: a) Technical Proposal (Volume I), and b) Business Proposal (Volume II). Each part shall be separate and complete in itself so that evaluation of one may be accomplished independently of evaluation of the other.

(b) The technical proposal shall not contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that your understanding of the Performance Work Statement can be evaluated.

The technical proposal must disclose your technical approach in sufficient detail to provide a clear and concise presentation that addresses, but is not limited to, the requirements of the technical proposal instructions. Additional information about the contents required for the Technical Proposal and Business Proposal, can be found at numbers 4 (Technical Proposal Instructions) and 5 (Business Proposal Instructions) of SECTION 12 titled “Instructions, Conditions, And Notices To Offerors”, respectively.

(c) The proposal must be signed by an official authorized to bind your organization.

(d) Proposals shall be submitted electronically. Offerors are permitted to submit more than one proposal submission.

(e) Offerors shall submit one (1) (non-editable PDF) copy of your technical proposal; and one (1) (Excel and non-editable PDF) copy of your business proposal. The technical and business proposal shall each be marked as “Original”.

(f) Electronic Proposal submissions must be addressed to the attention of Mrs. Candice L. Simmons and submitted as well as received at iie3@cdc.gov no later than 3:00 PM EST on 07/17/2020.

NOTE: Proposals will not be accepted via facsimile.

(g) Facsimile proposals are not authorized.

(h) The Government will evaluate proposals in accordance with the evaluation criteria set forth in SECTION 13 titled “Evaluation Factors for Award”.

4. TECHNICAL PROPOSAL INSTRUCTIONS

(a) The Vendor must submit a detailed technical proposal including information on the capabilities of the Vendor to respond to the requirements as defined in the PWS at SECTION 4 titled “Tasks to be Performed”. Proposals which merely offer to conduct a program in accordance with the requirements of the Government’s Performance Work Statement (PWS) on pgs. 3-19 of this solicitation will not be eligible for award. The technical proposal should be in as much detail as you consider necessary (within the 30-page limitation) to reflect a clear understanding of the nature of the work being undertaken.

(b) The written technical proposal shall include, at a minimum, the following sections which vendors shall use as the Table of Contents for the Technical Proposal:

mailto:iie3@cdc.gov

(1) TAB A - Cover Page (including solicitation number and name of Offeror)

(2) TAB B - Table of Contents, Appendices, Resumes of Key Personnel, CVs/Resumes, Proposal Preperation Certification (Attachment D.2), Signed Consent (Attachment D.5)

(3) TAB C - Concise Presentation of each of the Evaluation Criteria for the Overall Contract:

(a) Technical Approach

(b) Staffing/Management Plan

(c) Relevant Experience

(d) Quality Assurance

(4) TAB D - Past Performance

(c) The technical proposal shall not exceed 30 pages, excluding TAB A (cover page), TAB B (table of contents, appendices, resumes of key personnel, CVs/resumes), and D. The technical proposal shall be single spaced, single-sided, and on standard 8½ X 11-inch pages with 12 font characters. All pages in the written technical proposal must be sequentially numbered excluding TABS A, B, and D . Any pages beyond the first 30 pages will be ignored in the evaluation process. The technical proposal should “stand alone” with the appendices used only for clarifying or backup information. The technical proposal should be in as much detail as you consider necessary (within the thirty (30) page limitation) to reflect a clear understanding of the nature of the work being undertaken. The Contractor shall describe in a clear and succinct statement the problem, scope, purpose, and objectives of this solicitation in the Contractor’s own words to demonstrate his/her understanding of the intent and requirements of the contract and any potential challenges which may be encountered in completing the tasks/subtasks. The technical proposal must disclose your technical approach in sufficient detail to provide a clear and concise presentation that addresses, but is not limited to, the requirements of the technical proposal.

Refer to number L.9(e) above for submission instructions.

(d) The 30-page Technical Response under TAB C and submitted as part of the Technical Proposal (Volume I) should specifically address the following:

The Technical Proposal should include detailed information presented in the order specified below, including the following:

(d)(1) Technical Approach

i. The Offeror’s proposed Technical Approach must demonstrate their proposed technical approach to achieving all tasks outlined in the PWS. The technical approach response shall contain sufficient quantitative details (without reference to cost) to permit a complete and accurate evaluation of the approach from a strictly technical viewpoint. The proposed technical approach shall address the following:

a. A clear presentation of the proposal to ensure adequate monitoring of the proposed clinical study, including monitoring of clinical research sites, pharmacies, and laboratories.

b. A clear description of the Contractor’s approach to ensure the adequate protections of human subjects and adherence to the regulatory requirements of clinical research studies conducted under IND, including any training capacity and certifications the contractor possesses in this regard.

c. An understanding of possible risks and strategies to mitigate any anticipated risks should they arise.

d. An appropriate Project Management Plan.

e. A description of the proposed communication pathways between the contractor, clinical research site, and the DCC.

ii. As part of the proposed Technical Approach offeror shall review the following scenario and provide a detailed monitoring plan, including on-site and remote monitoring utilizing principles of risk-based monitoring. A description of metrics for tracking completion of monitoring activities and reporting to the sponsor should also be included. The proposed study parameters are:

TBTC Study A is a Phase III, TB prevention study evaluating a novel Latent Tuberculosis Infection (LTBI) treatment against standard of care. Total enrollment is 3,000 participants, 1,500 per arm. Basic eligibility criteria are: non-pregnant females and males, age 5 years and older, who are either contacts of an infectious TB case, or have evidence of TB infection in the form of a positive quantiferon test result.

The study…