toolkit

common protocol

h

case report

data elements

lab manuals

Z

mop

/

data sharing

The RePORT International Common Protocol was developed for collecting data and specimens from participants in the Regional Prospective Observational Research for TB (RePORT) Consortium. The primary purpose of the RePORT International project is to provide a platform for coordinated TB research by establishing a common set of standards and definitions that are used in the context of observational clinical research to perform clinical TB research. This will enable research studies to use pooled data and well-curated biological specimens for future analysis. The RePORT International Common Protocol describes the populations and processes for collecting the specimens and data.

Section update under progress. . .

common protocol

There are two documents attached in this section. One is the Common Protocol v1.1, 12 Jan 2016, exactly as it was reviewed and approved by the FHI 360 Protection of Human Subjects Committee (PHSC). The template version of this document has been revised to indicate sections that are customizable for individual RePORT International sites in preparation for local IRB submissions. This version is also on file with the FHI 360 PHSC.

common protocol v1common protocol template v1

case report formats

The International Common Protocol case report forms (CRFs) are based on the most current version of the RePORT Common Protocol and conform to the standard data elements. If CRFs are translated into the local language for data collection, they will need to be back-translated into English to verify their accuracy (i.e., the same as the standard English RI CRFs). For quick access to the entire group of CRFs, please download them. To download individual CRFs, please go to Resources, and download from there. Here is the full list of CRFs.

data elements

The RePORT International data elements form the core of the platform for data harmonization across all RePORT consortia. The data elements are the building blocks for the RePORT CRFs and the backbone of each consortia’s data repository, which is intended to be pool-able and merge-able across all RePORT Consortia in the context of specific research queries or projects. The RICC serves as the keeper and curator of the RePORT data elements bank. The RICC is responsible for any/all revisions and additions as needed in consultation with the executive committee. 

Please note: The data elements are only in English; all data received from each consortia’s data repository are expected to be in English.

laboratory manual

While the RePORT International Common Protocol (CP) provides instructions for the types and timing of specimens, the CP Laboratory Manual provides detailed instructions for how to collect, process, and store specimens, including interfacing with laboratory management systems, labelling, and retrieval.

Note: Some individual consortia have created locally customized lab manuals, especially for procedures related to their parent protocols. If interested, please contact RICC or individual consortia to get examples. Please remember it is not acceptable to modify any procedures or processes described in the CP Laboratory Manual at the local level. If such modifications are thought to be needed, they will require discussion across the consortia, and be agreed upon by the executive committee.

manual of operating procedures

The RePORT International Common Protocol (CP) provides instructions for the types and timing of specimens; the CP Laboratory Manual provides detailed instructions for how to collect, process, and store specimens; and the MOP provides detailed instructions for every other aspect of the common protocol.

Note: Some individual consortia have created locally customized manuals of procedures, especially for procedures related to their parent protocols. If interested, please contact RICC or individual consortia to get examples. Please remember it is not acceptable to modify any procedures or processes described in the CP MOP at the local level. If modifications are thought to be needed, they will require discussion across the consortia and be agreed upon by the executive committee.

special modules

Special modules that cover the collection of specialized specimens or that are related to specific populations (pediatric, MDR TB, TB meningitis) may be developed in the future and will be located here. If there are specialized modules that you would like to post in this space, please write to us.

connect@reportinternational.org

data sharing agreements

If RePORT International data is 1st transferred to an authorized RePORT International Consortium Data Management Center (CDMC), RePORT International Coordinating Center (RICC) requires the CMDC to enter into a formal Data Sharing Agreement prior to the sharing of any RePORT International data between themselves and the RICC. This file is the current RePORT International RICC-CDMC Data Use Agreement.

RePORT International Coordinating Center (RICC) requires each Data Clinic (data producer) to enter into a formal Data Sharing Agreement prior to the sharing of any RePORT International data between the Data Clinics and the RICC. This file is the current RePORT International RICC-Data Producer Data Use Agreement.