MODIFICATION
A -- Clinical Trial Monitoring in Botswana
- Notice Date
- 6/17/2009
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2009-N-11271
- Archive Date
- 5/21/2009
- Point of Contact
- Terren J. Grimble, Phone: 770-488-2487, Carlos M Smiley, Phone: 770-488-1517
- E-Mail Address
-
TGrimble@cdc.gov, anx3@cdc.gov
(TGrimble@cdc.gov, anx3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Title: Clinical Trial Monitoring for CDC-Funded Clinical Safety and Efficacy Study of Daily Oral Antiretroviral Use for Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana Description(s): The Center for Disease Control and Prevention (CDC), Procurement and Grants Office announces the upcoming release of the solicitation for CDC-funded BOTUSA, a collaboration between the Government of Botswana and CDC, to conduct clinical safety and efficacy trial monitoring in Botswana. The purpose of this contract is to conduct Phase II/III safety and efficacy trials to determine whether antiretroviral theraphy (ART) taken as pre-exposure prophylaxis (PrEP) is safe on a long-term basis and whether it reduces the rate of acquisition of HIV infection. In Botswana, the trial will be done with heterosexually active young adult men and women in Gaborone and Francistown. Tenofovir (TDF) was the agent initially chosen for the study in Botswana. Six months after the study start the decision was made to change the study drug to Truvada® which is a combination of TDF and emtricitabine (FTC). Participants in both studies are randomized to receive either study drug or its placebo and will be followed for any adverse effects of the agent, any changes in their sexual or injection drug risk behavior, and HIV incidence. Results of this study will determine whether Truvada® is safe and effective as long-term prophylaxis against HIV infection among those exposed sexually or by injection drug use in addition to standard risk reduction methods. A study overview of the Phase II/III trials includes the following: • Study design for placebo-controlled safety/efficacy study o Botswana  600 male and 600 female, healthy, sexually active, HIV-uninfected persons ages 18-39  2 Locations: Gaborone and Francistown  All clinics and laboratories (diagnostic and research) related to the study at each of two locations. • Study timeline o Preparation start date: September 2009 o Screening/Enrollment: Estimated 10 months o Follow-up: Estimated 24 months o Analysis: Estimated 6 months • Study visit schedule: screening, screening revisit, enrollment, then monthly • Laboratories o Botswana: Clinical labs at each of two sites and a research lab in Gaborone There are two stages in this contract. The first stage of the contract will begin September 2009 and will last until participant follow-up is completed. The second stage will begin after the last day of the first stage and will cover the extended time period needed to complete closeout and participant follow-up and closeout activities at the Botswana site (projected to be December 2012). Specific tasks within each stage are outlined below. STAGE I Task 1. Regulatory Activities 1. The contractor shall review the investigator regulatory document packages for the CDC-funded site (Form 1572, etc.) and provide advice to the site on the completeness and accuracy of the packages. CDC will track and obtain annual Internal Review Board (IRB) renewals at the site and COTR. 2. The contractor shall periodically review original documents pertaining to site and data management in a Trial Master File (maintained by each CDC-funded site) according to the Food and Drug Administration (FDA) requirements for retention of study-related documents. 3. The contractor shall provide CDC with a copy of their Standard Operating Procedures (SOPs) and any updates. Task 2. Site Monitoring and Management 1. The contractor will conduct monthly ongoing monitoring visits at each investigative site to successfully monitor the conduct of this trial. In addition, a minimum of three laboratory monitoring visits per year will be required. In cooperation with CDC, the contractor will adjust this interval according to clinical site accrual, site performance, adherence to the protocol, and data quality. Each ongoing monitoring visit is assumed to take minimum of 5 days total for preparation, travel, on site activities, and report writing. The monitoring visits shall include: • 100% review of all major documents related to the study endpoints as well as participant eligibility and safety. Minor documents which are not as important (i.e. checklists) would be randomly selected for review as necessary per guidelines and regulations. • Continuous evaluation of data received regarding the safety and efficacy of the test drug, taking appropriate action, as indicated by any pertinent federal or state law and regulation, or as requested by CDC. • Review of subject records and case report forms for accuracy and completeness of information/data, compatibility with source documents and investigator review/signature. • Annual review of regulatory documentation (including CVs, Form FDA 1572, IRB approvals, safety reporting, etc.), and documenting deficiencies, assisting in the follow-up/corrections with the clinical site staff, and collecting updated or revised regulatory documentation. • Conduct a quarterly drug inventory and a monthly review of pharmacy records to ensure compliance with relevant guidelines and regulations. The review of pharmacy records would include but not be limited to: medication dispensing logs; documentation of receipt, supply, and storage procedures of clinical trial products; any updated pharmacy related training records and curriculum vitae of pharmacist or designee, etc. In addition, the monitor will conduct an initial review of pharmacy standard operating procedures (SOPs) and annually thereafter, unless there are changes. • Annual review of laboratory assessments to ensure compliance with Good Laboratory Practice (GLP) and assure the integrity of the study. 2. The contractor will: • Verbally report any significant findings to CDC with 24 hours following the monitoring visit. • Complete and deliver to CDC, within 10 working days of the monitoring visit, a written visit report, following the specification of CDC's Standard Operational Procedures (SOPs or the contractor's SOPs if deemed appropriate by CDC and documented). The report will include, but not be limited to: screening, eligibility, and enrollment accrual, visit compliance; safety issues identified (e.g., Serious Adverse Events (SAE) reports), consent form and CRF completion; data entry and management compliance, laboratory quality control/quality assurance (QC/QA) results, status of regulatory documents, drug accountability, summary report on OraQuick test kit inventory, etc. The report will include a summary of the pertinent points from each visit and any recommended or agreed upon actions. 3. The contractor will maintain monthly telephone contacts with study sites throughout the trials and generate brief telephone reports of verbal correspondence with sites to monitor for compliance with study procedures. Task 3. Site Staff Training The contractor shall provide GCP, GCLP and GLP-related training to site staff as indicated by results of monitoring visits. For purposes of planning, seven days with two trainers for Botswana should be budgeted per year. Task 4. Project Management and Team Training 1. The contractor shall assign a single project manager for each CDC-funded site to serve as a main point of contact for discussion of program-related issues. 2. The contractor shall generate quarterly written project status reports for each CDC-funded site in a mutually agreed-upon format. 3. The contractor shall be responsible for providing program-specific training to contractor personnel assigned to the study. It is expected that personnel assigned to this study will continue to work on this project until its completion. If personnel change due to unforeseen circumstances, the contractor shall assume the cost of training new staff. STAGE II Task 1. Regulatory Activities 1. The contractor shall review the investigator regulatory document packages for the CDC-funded sites (Form 1572, etc.) and provide advice to the sites on the completeness and accuracy of the packages.. CDC will track and obtain annual Internal Review Board (IRB) renewals at the sites and CDC. 2. The contractor shall periodically review original documents pertaining to site and data management in a Trial Master File according to the Food and Drug Administration (FDA) and Botswana Ministry of Health, Drug Regulatory Authority requirements (or whichever is more strict) for retention of study-related documents. 3. The contractor shall provide COTR with a copy of their Standard Operating Procedures (SOPs) and any updates. Task 2. Site Monitoring and Management 1. The contractor will conduct monthly ongoing monitoring visits at each investigative site in Botswana to successfully monitor the conduct of this trial. In addition, a minimum of three laboratory monitoring visits per year will be required. In cooperation with CDC, the contractor will adjust this interval according to clinical site accrual, site performance, adherence to the protocol, and data quality. Each ongoing monitoring visit is assumed to take minimum of 5 days total for preparation, travel, on site activities, and report writing. The monitoring visits shall include: • 100% review of all major documents related to the study endpoints as well as participant eligibility and safety. Minor documents which are not as important (i.e. checklists) would be randomly selected for review as necessary per guidelines and regulations. • Continuous evaluation of data received regarding the safety and efficacy of the test drug, taking appropriate action, as indicated by any pertinent federal or state law and regulation, or as requested by CDC. • Annual review of regulatory documentation (including CVs, Form FDA 1572, IRB approvals, safety reporting, drug accountability, etc.), and documenting deficiencies, assisting in the follow-up/corrections with the clinical site staff, and collecting updated or revised regulatory documentation. • Conducting a quarterly drug inventory and a monthly review of pharmacy records to ensure compliance with relevant guidelines and regulations. The review of pharmacy records would include but not be limited to: medication dispensing logs; documentation of receipt, supply, and storage procedures of clinical trial products; any updated pharmacy related training records and curriculum vitae of pharmacist or designee, etc. In addition, the monitor will conduct an initial review of pharmacy standard operating procedures (SOPs) then annually thereafter, unless there are changes. • Annual review of laboratory assessments to ensure compliance with Good Laboratory Practice (GLP) and assure the integrity of the study. 2. The contractor will: • Verbally report any significant findings to COTR with 24 hours following the monitoring visit. • Complete and deliver to CDC, within 10 working days of the monitoring visit, a written visit report, following the specification of CDC's Standard Operational Procedures (SOPs or the contractor's SOPs if deemed appropriate by CDC and documented). The report will include, but not be limited to: screening, eligibility, and enrollment accrual, visit compliance; safety issues identified (e.g., Serious Adverse Events (SAE) reports), consent form and CRF completion; data entry and management compliance, laboratory quality control/quality assurance (QC/QA) results, status of regulatory documents, drug accountability, summary report on OraQuick test kit inventory, etc. The report will include a summary of the pertinent points from each visit and any recommended or agreed upon actions. 3. The contractor will maintain monthly telephone contacts with study sites throughout the trials and generate brief telephone reports of verbal correspondence with sites to monitor for compliance with study procedures. 4. The contractor will conduct closeout visits for each study. Each closeout visit is assumed to take 5-6 days for preparation, travel, on-site activities and report writing. Task 3. Site Staff Training The contractor shall provide GCP, GCLP and GLP-related training to site staff in Botswana as indicated by results of monitoring visits. For purposes of planning, seven days with two trainers for Botswana should be budgeted per year. Task 4. Project Management and Team Training 1. The contractor shall assign a single project manager for to serve as a main point of contact for discussion of program-related issues. 2. The contractor shall generate quarterly written project status reports in a mutually agreed-upon format. 3. The contractor shall be responsible for providing program-specific training to contractor personnel assigned to the study. It is expected that personnel assigned to the study will continue to work on this project until its completion. If personnel change due to unforeseen circumstances, the contractor shall assume the cost of training new staff. Task 5. Data cleaning, analysis, and presentation Provide support and assist Botswana in TDF2 data cleaning, verification, correction. The anticipated period of performance is September 1, 2009 through December 31, 2012. All responsible qualified entities are invited to submit a proposal to be considered by the Government. Award is expected to be made on or before September 1, 2009.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2009-N-11271/listing.html)
- Place of Performance
- Address: Gaborone & Francistown Botswana, Botswana
- Record
- SN01848356-W 20090619/090618000352-b85e8346489efac36b64099b4d8f0402 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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