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Round

CRF Modules

Current Status of Module

1

Demography

Harmonization complete; Standards presentation 9/3/09, pending final approval

2

Adverse Events

Harmonization complete; preparing for standards review

2

Enrollment

Harmonization complete; preparing for standards review

2

Medical History

Harmonization complete; preparing for standards review

2

Participant Identifier

Harmonization complete; preparing for standards review

2

Physical Exam

Harmonization complete; preparing for standards review

2

Protocol Deviations

Harmonization complete; preparing for standards review

2

Registration

Harmonization complete; preparing for standards review

3

[Agents Vocabulary

https://wiki.nci.nih.gov/pages/viewpage.action?pageId=21104330

]

Harmonization nearing completion

3

Study Administration

Harmonization nearing completion

3

Drug Accountability

Harmonization nearing completion

3

Concomitant Medications

Harmonization nearing completion

3

Pre/Post Treatment

Harmonization nearing completion

3

Laboratory Tests & Results

Harmonization nearing completion

3

Outcome Measures

Harmonization nearing completion

3

Outcome Measures Glossary

Harmonization nearing completion

3

Staging & Extent of Disease

Harmonization nearing completion

4

Diagnosis & Pathology

Harmonization in progress, in workgroup meetings

4

Eligibility Criteria

Harmonization in progress, in workgroup meetings

4

Header Information

Harmonization in progress, in workgroup meetings

4

Imaging & Radiology

Harmonization in progress, in workgroup meetings

4

Non- Agent Study Interventions

Harmonization in progress, in workgroup meetings

4

Off Treatment_Off Study

Harmonization in progress, in workgroup meetings

4

Vital Signs

Harmonization in progress, in workgroup meetings

Introduction

The Standardized Case Report Form (CRF) Work Group is focused on establishing a core library of harmonized and standardized Phase II and III CRFs and data collection modules through stakeholder consensus. A core library of harmonized and standardized CRFs will be highly valuable to the cancer clinical trials community because it will provide a standardized mechanism for comparing and aggregating information across the NCI's clinical trial portfolio. Additionally, a harmonized CRF library will improve the efficiency and accuracy of the routine review of safety, efficacy, and administrative data from ongoing NCI-funded clinical trials. Finally, by reducing the time spent in developing a data collection strategy per trial, this core library will allow for faster initiation of new trials; thus, speeding the process of delivering new and improved treatments to patients.

The Standardized CRF Work Group is part of the Study Conduct Special Interest Group (SIG) and the Clinical Trials Management Systems (CTMS) Workspace.

Harmonization/Standardization Process

The CRF Harmonization and Standardization initiative has undertaken the task of harmonizing and standardizing case report forms for cancer clinical trials by first dissecting the CRF into modules and tackling smaller sections of the CRF 5 areas at a time.  The general process includes collecting an inventory of forms related to the information generally captured in that module, for example, On-Study Forms are collected to gather Agent information.  The group then goes through all the forms and identifies those fields that are relevant to that module (area), partitions the fields as either Mandatory, Conditional or Optional, and then identifies appropriate Common Data Elements (CDEs) or creates new CDEs to accurately capture the metadata for the harmonized fields.  Once the group identifies all the fields and CDEs to be collected in that module, these are sent to the Clinical Trials Community for review and comment, the comments are addressed, and the final list of fields are presented to the Clinical & Translational Research Operating Committee (CTROC) for final approval.  After CTROC approval, the module is officially available for use on cancer clinical trials.

Status of CRF Activities

The first Round of the CRF Harmonization & Standardization Project addressed a single module, Demography.  This work began in June 2007, and the module has gone through the the entire process and has been approved by CTROC, and is currently undergoing implementation/deployment for use in cancer clinical trials.

Round 2 included Adverse Events, Baseline Assessment, Participant Identification, Registration & Enrollment, and Protocol Deviations.  Seven modules were completed from those 5 areas, which are Adverse Events, Medical History, Physical Exam, Participant Identification, Registration, Enrollment, and Protocol Deviations.  These seven modules have been vetted by the Community and is awaiting CTROC approval.

The Working Groups, comprised of a diverse group of individuals from the cancer clinical trials community are currently harmonizing modules for Round 3.  The Community consists of individuals from various divisions with NCI, clinicians, physicians, data managers, and statisticians from cancer centers and pharmaceutical companies involved in clinical trials.  Round 3 modules include Agents (looking at both standardizing vocabulary and the variables to be collected), Laboratory Tests/Results, Outcome Measures, and Staging/Extent of Disease.  These groups are still harmonizing their inventory of CRFs and identifying/creating CDEs for the harmonized fields.

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