Tuberculosis Trials Consortium Study 35
8/7/2019 - Amendment 00002 posted
8/2/2019 - Amendment 00001 posted
7/22/2019 - Solicitation posted
Pre-solicitation Notice
The Tuberculosis Trials Consortium (TBTC) is a domestic and international network of clinical research sites conducting programmatically relevant research on the treatment and prevention of tuberculosis disease.
TBTC Study 35 is a Phase I/II dose finding and safety study of rifapentine and isoniazid in HIV-infected and HIV-uninfected children with latent tuberculosis infection. CDC is the sponsor for TBTC trials.
The Centers for Disease Control and Prevention (CDC) will issue a solicitation for a contract to obtain services to provide on-site monitoring of the clinical research sites, pharmacies, and laboratories participating in TBTC Study 35, 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. This on-site monitoring will include, at a minimum, regulatory document review, source document verification, study product accountability, and laboratory compliance visits. This trial will be conducted only in South Africa, in Johannesburg and Cape Town, at a minimum of three clinical research sites.
As this trial is conducted as an investigational new drug, it has the potential to be audited by US Food & Drug Administration and/or European Medicines Agency, and is the first trial of the study product administered to children. CDC's risk tolerance for this protocol is low. The following will be required:
• On-site initiation visits for all participating sites prior to first enrollment;
• On-site 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 Data & Coordinating Center of the TBTC, housed within CDC's Division of TB, 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 35 monitoring plan incorporating principles of risk based monitoring;
• Documentation of obligations transferred from sponsor to CRO;
• Central monitoring of Study 35 data and activities;
• Quality assurance of Study 35 data; and
• Pre-site visit reports and information prioritizing tasks at on-site visits.
A single contract award is contemplated. It is anticipated that the resulting contract will be a Fixed Price, Definitive Contract. The period of performance will include one 12-month base year and one 12-month option period, for a total period of performance of 24 months.
Place of Performance:
Work under this contract will be performed at the following places:
• Contractor's facility;
• Stellenbosch University;
o Desmond Tutu TB Centre, Francie van Zijl Avenue, Clinical Building, K Floor, Tygerberg Hospital, Cape Town
o Brooklyn Chest Hospital, Stanberry Street, Ysterplaat, Cape Town
o KIDCRU, Francie van Zijl Avenue, Ward J8, Tygerberg Hospital, Cape Town
• Perinatal HIV Research Unit at Chris Hani Barangwanath Hospital, Soweto, South Africa.
• TASK Pharmacy, Cape Town
o FAMCRU
o Brooklyn Chest
• BARC (Laboratory), Johannesburg (note that there are 2 additional processing/shipping centers in Johannesburg and Soweto)
• University of Cape Town Lung Institute (Laboratory), Cape Town
This is a full and open competition
The anticipated release date of the Request for Quotation (RFQ) will be on or about July 2, 2019 posted on https://www.fbo.gov. Any amendments issued to the solicitation will also be made at the same website.
All responsible sources may submit a quotation in response to the forthcoming RFQ, which shall be considered by the agency. The RFQ due date will be approximately seventeen (17) days after the posting of the solicitation and is subject to be revised if necessary.
No questions will be answered in response to this pre-solicitation. The RFQ will provide instructions for submitting questions.
No telephone calls will be accepted or returned. No emails will be returned.
This is not a request for Capability Statements.
Timothy Barnes, Contract Specialist, Phone 7704882883, Email krz3@cdc.gov
