toolkit
common protocol current version
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 version of common protocol v1.1
common protocol
Summary of Key Changescase report forms
The RePORT 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 access to the current case report forms, please click on the blue button below. If you would like access to the original set of case report forms from 2015, please email tbricc@njms.rutgers.edu.
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
The RePORT International CP Laboratory Manual of Operating Procedures provides detailed instructions on how to collect, process, and store specimens, including interfacing with laboratory management systems, labelling, and retrieval. 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.
Currently, the CP Laboratory Manual is undergoing significant modifications. If you would like to access the previous version from 2015, please email tbricc@njms.rutgers.edu.
Current Version of Lab MOP Coming Soon
Clinical Manual of Operating Procedures
The RePORT International Common Protocol (CP) provides information on the CP study design, cohorts, clinical and lab evaluations, schedules of events, and data collection. The Clinical MOP augments this information with more detailed instructions for the implementation of the Common Protocol. 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.
The RePORT International Clinical MOP has been temporarily removed while it is undergoing significant modifications to align with the newest version of the Common Protocol. If you would like access to the previous version from 2015, please email tbricc@njms.rutgers.edu.
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
Specimen Shipment Tips
– – Last updated October 26, 2024 – –