Collaboration

tbricc@njms.rutgers.edu

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Process

Concept sheet

Data availability

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Specimen availability

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Regulatory docs

RePORT International welcomes collaborations with all interested investigators. The RePORT International Coordinating Center will facilitate collaborations requesting data or samples from two or more RePORT country networks. If a proposed project requires data or specimens from only one RePORT country, we recommend contacting that RePORT country network directly to expedite the process.

An overview of our collaboration process, available data elements, and biological specimens is presented below.

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Collaboration Process

Research in RePORT International follows a concept sheet-driven process. We require a RePORT Collaborating Investigator for external investigators interested in working with RePORT data and/or samples. This RePORT Collaborating Investigator can help to determine the feasibility of the project and facilitate the concept development and review process. Interested investigators who do not have a current RePORT partner can contact the RePORT International Coordinating Center.

The concept sheet is then reviewed by the RePORT International Coordinating Center for general content and completeness, the RePORT International Scientific Review Committee (SRC) for scientific rigor, and the Executive Committee for feasibility and final endorsement. Completed concept sheets should be emailed to tbricc@njms.rutgers.edu.

Concept sheet template

DATA AVAILABILITY

The participating networks of RePORT International collect a variety of longitudinal data elements as part of the RePORT Common Protocol, which defines two cohorts: Cohort A (TB cases) and Cohort B (close contacts of TB cases). The protocol includes the following study visits for Cohort A: baseline/enrollment, Month 1, Month 2, End of TB Treatment, 6-Month post-Treatment, and at the time of Treatment Failure/Relapse/Withdrawal.

The RePORT International coordinating center has harmonized the following variables for Cohort A across five RePORT countries (India, Brazil, South Africa, Indonesia, Philippines).

You can review the variables and code lists defined in our Common Data Model at tbreportdes.org.

  • Baseline characteristics (date of birth/age, sex, marital status, education level, income category, dwelling type)
  • Medical history and behavioral characteristics (BCG vaccination, smoking history, alcohol use, HIV status)
  • Visit-based measures (height, weight, TB symptoms, TB treatment adherence)
  • TB laboratory test results (TB smear, TB culture, drug sensitivity testing, GeneXpert, IGRA, TST)
  • Other laboratory results (HIV test, CD4 cell count, HIV viral load, hemoglobin, hematocrit, HbA1C)
  • Chest x-ray (image and interpretation)
  • TB medications (drug name, dose, frequency, start/end dates, reason for change or stop of a drug, use of DOT)
  • Other medications (limited data available)
  • Other diseases and conditions (limited data available)
  • TB treatment outcomes (clinical and bacteriologic outcomes of TB treatment per WHO definitions)
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SPECIMEN AVAILABILITY

The participating networks of RePORT International collect specimens at the following study visits for Cohort A (TB cases) and Cohort B (close contacts): baseline/enrollment, Month 1, Month 2, End of TB Treatment (if applicable), and and at the time of Treatment Failure/Relapse/Withdrawal. Not all specimens may be available at all time points or from all participating networks.

The use of specimens should be presented in a concept sheet proposal and will be reviewed by the RePORT International Scientific Review Committee. Recipients are responsible for specimen shipping costs.

Specimens may include plasma, PAXgene, PBMCs, urine, saliva, sputum, and MTB isolates.

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Regulatory Documents and Approvals

RePORT data and samples are owned and managed by the individual country networks. The RePORT International Coordinating Center provides oversight and coordination for multi-country projects. Research projects with RePORT International generally require updated country or site-level ethics approvals, as well as material transfer agreements (MTAs) for specimen shipping. The RePORT International Coordinating Center can help coordinate this for investigators, as the requirements can differ for each country.

Please note that the RePORT Executive Committee needs to review and approve all abstracts and manuscripts that use RePORT data. This process can take several weeks and must be completed in advance of submitting those scientific products to a conference or journal.

Contact

Please contact the RePORT International Coordinating Center with any questions.