MODIFICATION
A -- Clinical Trial Monitoring in Thailand
- 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-11270
- 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 Tenofovir to Prevent HIV Infection Among Injection Drug Users in Thailand. Description(s): The Center for Disease Control and Prevention (CDC), Procurement and Grants Office announces the upcoming release of the solicitation for Clinical Monitoring Services for Thailand. The anticipated period of performance is as follows: Period of Performance Base 09/01/09 - 12/31/09 Option 1 - 01/01/10 - 06/30/10 Option 2 - 07/01/10 - 12/31/10 Option 3 - 01/01/11 - 06/30/11 Option 4 - 07/01/11 - 12/31/11 CDC has funded BTSG and established a collaboration between the Bangkok Metropolitan Administration (BMA), the city government of Bangkok, the Thailand Ministry of Public Health (MOPH), and U.S. CDC to conduct Phase II/III safety and efficacy trial to determine whether ART taken as PrEP is safe on a long-term basis and whether it reduces the rate of acquisition of HIV infection. In Thailand, the trial will enroll injection drug users at 17 drug treatment clinics in Bangkok. The purpose of this project is to identify a contractor that can provide a comprehensive package of clinical trial monitoring for a CDC-funded clinical safety and efficacy trial to be conducted as a collaborative project by the Thailand by the Thailand MOPH - U.S. CDC Collaboration (TUC). Overview of the Bangkok Tenofovir Study: • Study design o Randomized, double-blind, placebo-controlled, endpoint-driven trial o Participants: 2400 male and female, otherwise healthy, HIV-uninfected persons with recent injection use who are attending drug treatment centers o Study sites: 17 BMA drug treatment clinics • Study timeline o Screening and enrollment start date: June 2005 o Enrollment period: 48 months o Treatment period: Until 40 endpoints have been reached or until the study is stopped by the sponsor (projected September 2009) • Study visit schedule: screening, pre-enrollment, enrollment, monthly, 3-monthly, and exit • Laboratories o Thailand: A clinical and research BMA laboratory and the CDC/HIV laboratory at TUC Specific Contract Stages 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 in Thailand. 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 (BTSG office) 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 CDC. 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 one laboratory monitoring visit 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 2-3 days total for preparation, travel, on site activities, and report writing. The interim monitoring visits shall include: • 100% review of all major documents related to the study endpoints as well as participant eligibility and safety. Minor documents (i.e. checklists) would be randomly selected for review as necessary per CDC. • 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. • Bi-annual review of regulatory documentation (including CVs, 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. • Review monthly study drug log for completeness. Review dispensing logs, study drug receipt and return records, and study drug storage procedures. 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, status of regulatory documents, drug accountability,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 1. The contractor shall provide GCP to site staff as indicated by results of monitoring visits. For purposes of planning,, five days of training per year. Training slides will be translated to Thai for the GCP training in Thailand. Contractor shall provide venue for training in Thailand Task 4 - Project Management and Team Training 1. The contractor shall generate quarterly written project status reports for each CDC-funded site in a mutually agreed-upon format. 2. The contractor shall be responsible for providing program-specific training to contractor personnel assigned to the study. It is expected that personnel assigned to these studies 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 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) 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 in Thailand to successfully monitor the conduct of this trial. In addition, a minimum of one laboratory monitoring visit 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 2-3 days total for preparation, travel, on site activities, and report writing. The interim monitoring visits shall include: • 100% review of all major documents related to the study endpoints as well as participant eligibility and safety. Minor documents (i.e. checklists) would be randomly selected for review as necessary per CDC. • 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. • Bi-annually review of regulatory documentation (including CVs, 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. • Review study drug log for completeness. Review dispensing logs, study drug receipt and return records, and study drug storage procedures. 2. The contractor will:Verbally report any significant findings to CDC with 24 hours following the monitoring visit. Followed by a written report. • 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 which is assumed to take 3-4 days for preparation, travel, on-site activities and report writing. Task 3 - 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 studies 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 4 - Data cleaning, analysis, and presentation 1. Provide support and assist TUC in BTS data cleaning, verification, correction. Award is expected to be made on or before 9/01/2009.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2009-N-11270/listing.html)
- Place of Performance
- Address: Bangkok, Thailand, Bangkok, Thailand
- Record
- SN01847783-W 20090619/090617235549-1437d14cdfe40253728acdf8b3f5bf62 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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