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.

current common protocol v2.1 jul 2024

previous versions of common protocol

common protocol

Summary of Key Changes
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case report forms

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.

cohort a

Active Pulmonary TB Provisional Enrollment Form

Clinical and Demographic Information Form

Eligibility Confirmation Form

Follow-up Evaluation

Tuberculosis Treatment Form

Final Outcome Determination Form

Off Study Form

cohort B

Latent TB Infection Enrollment Form

Clinical and Demographic Information Form

Follow-up Evaluation

Final Outcome Determination Form

cohort a & B

HIV Testing and CD4 Form

Hematology Form

Chest X-Ray Form

Sputum Specimen Transport Form

Sputum Specimen Processing and Storage Form

Specimen Transport Form

Mycobacteriology Lab Form

MTB Isolate Storage Form

informed consent forms

4 sample Informed Consent Form templates that accompany the revised Common Protocol (version 2.1 8 July 2024) are available to download below.

Cohort A Consent

Cohort A Assent

Cohort B Consent

Cohort B Assent

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.

Data Elements Bank

Data Elements Bank – Overview and Application Guide

Laboratory Manual of Operating Procedures

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.

Previous Version of Lab MOP V2.0 Apr 2015

Current Version of Lab MOP Coming Soon

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Clinical 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.

Previous Version of Clinical MOP V0.2 Aug 2015

Current Version of Clinical MOP Coming Soon

FreezerPro

The FreezerPro is a scalable web-based sample inventory management system that delivers secure management of samples and sample information. It allows:

Tracking samples in and out of freezers
Reporting & data export/import (multiple formats)
Live & smart searching
Viewing full audit trails

FreezerPro training

The training documents and videos were prepared by the Rutgers Data and Operations Management Center (DOMC). Please note that some of the documents and videos use examples from non-REPORT International studies. Click on the button below for additional resources 

Full Playlist

Introduction to FreezerPro

Overview

Setting up FreezerPro

Setup Guide

Creating Account SOP

New Site Instructions SOP

Adding Users

Creating User Groups

Creating Freezers and Access Permissions

Setting up Printers and Access Permissions

Creating Box Types

Creating and Printing Labels SOP

Creating and Printing Labels

Sample Flow

Adding Barcode Printers

Creating Sample Type and Access Permissions SOP

FreezerPro Data Cleaning and Manipulation

Data Cleaning SOP

Data Cleaning Video

Data Manipulation Video

FreezerPro Sample Movement tracking

Sample Disposal SOP

Sample Disposal

Samples Tested and Shipped SOP

Samples Removed for Testing and Shipping

Refreezing Remaining Samples SOP

FreezerPro Activity Monitoring

Audit Log SOP

– – Last updated October 26, 2024 – –