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Module Status Table

CRF Modules

Round #

Current Status of Module

Adverse Events

2

Internal Harmonization complete; Expanded Committee Review completed.

Base Intervention

3

Internal Harmonization complete; Expanded Committee Review in session.

Concomitant Medication Agents

3

Internal Harmonization complete; Expanded Committee Review in session.

Consent

4

Internal Harmonization complete; Expanded Committee Review will follow Round 3.

Demography

1

Harmonization complete; Approved as standard on NCI CRFs.

Diagnosis and Pathology

4

Internal Harmonization complete; Expanded Committee Review will follow Round 3.

Drug Accountability

3

Internal Harmonization complete; Expanded Committee Review in session.

Eligibility Criteria

4

Internal Harmonization complete; Expanded Committee Review will follow Round 3.

End of Form

3

Internal Harmonization complete; Expanded Committee Review in session.

Enrollment

2

Internal Harmonization complete; Expanded Committee Review completed.

Footer

3

Internal Harmonization complete; Expanded Committee Review in session.

Header Information

3

Internal Harmonization complete; Expanded Committee Review in session.

Imaging and Radiology

4

Internal Harmonization complete;  Expanded Committee Review will follow Round 3.

Laboratory Tests and Results

3

Internal Harmonization complete; Expanded Committee Review in session.

Medical History

2

Internal Harmonization complete; Expanded Committee Review completed.

Non-Agent Study Interventions

4

Internal Harmonization complete; Expanded Committee Review will follow Round 3.

Off Treatment_Off Study

4

Internal Harmonization complete; Expanded Committee Review will follow Round 3.

Outcome Measures

3

Internal Harmonization complete; Expanded Committee Review in session.

Participant Identifier

2

Internal Harmonization complete; Expanded Committee Review completed.

Physical Exams

2

Internal Harmonization complete; Expanded Committee Review completed.

Pre and Post Treatment Agents

3

Internal Harmonization complete; Expanded Committee Review in session.

Protocol Deviations

2

Internal Harmonization complete; Expanded Committee Review completed.

Registrations

2

Internal Harmonization complete; Expanded Committee Review completed.

Screening

4

Internal Harmonization complete; Expanded Committee Review will follow Round 3.

Staging and Extent of Disease

3

Internal Harmonization complete; Expanded Committee Review completed.

Study Agent Administration

3

Internal Harmonization complete; Expanded Committee Review in session.

Vital Signs

4

Internal Harmonization complete; Expanded Committee Review will follow Round 3.

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 CDEs are brought to the Vocabularies & Common Data Elements (VCDE) Workspace for review as caBIG Standards. Once the CDEs are made standard, the module is officially available for use on cancer clinical trials.

In October of 2009, the need for an Expanded Committee Review was identified.  A change in the community review process was instituted in the Spring of 2010. The revised process is as follows:

Step

Action

1

NCI CBIIT staff create CRF inventory

2

Working group aggregates and identifies key content, resolves discrepancies, harmonizes - expansion in working group membership to include named point of contacts (POCs) for all major internal and external clinical trial stakeholders

3

Working group partitions content - mandatory, conditional, optional

4

Working group achieves consensus on final list of elements, assures adherence to data standards

5

Executive summary sent to Clinical and Translational Research Operations Committee (CTROC)

6

Module circulated for broad community review

7

Working group reviews and responds to changes from community review  - POCs for all major internal and external clinical trial stakeholders provide formal approval of CRF elements prior to subsequent review

8

CRF Subcommittee of the CTMS Steering Committee reviews and approves - newly formed subcommittee ensures review by critical external clinical trial stakeholders, e.g., NCI cooperative groups

9

CTROC reviews and approves

10

Annual review cycle

Status of CRF Activities

The first Round of the CRF Harmonization and 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 the CDEs have been made standard. The module is 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 approved by CTROC. In the spring of 2010 the seven modules entered expanded community review. Community review completed three rounds of evaluation through 2010 and in March of 2011 was forwarded to NCI leadership for finalization.

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 modules have been reviewed by the Community, presented to CTROC, and are undergoing final review by specific groups in the cancer clinical trials community. It is anticipated that this set of content will be finalized in April of 2011.

The Round 4 modules: Header Information, Imaging/Radiology, Non-agent Study Interventions, Diagnosis/Pathology, Vital Signs, Eligibility Criteria, and Off Treatment/Off Study have completed the first round of harmonization in small workgroups. They will enter expanded community review upon the completion of Round 3 content, sometime in the spring of 2011.

Round 5 modules have not been identified at this point, but most likely will include Imaging variables, specifically Recist criteria. Additional content will be identified following a gap analysis once Round 4 work is complete.

Metrics

The CRF Harmonization & Standardization project was initiated to provide a harmonized and standardized set of variables to be collected for oncology clinical trials that could be implemented to facilitate data entry, and study aggregation, comparison and analysis. The CRF collection process for Rounds 1-3 only collected Case Report Forms specific for that module. However, prior to Round 4, the Workgroup Leads recommended collecting CRFs for all areas and doing a single CRF inventory for all remaining modules, current and future Rounds.

The general metrics from the Round 4 CRF Inventory include:

17 Contributing Organizations
Contributing Organizations: CCR, DCP, University of Pennsylvania, CDASH, NCCTG, CTMS Theradex, CIP (FIMSO), UCSD, CALGB, COH, ACOSOG, Duke, ACRIN, ECOG, University of Michigan, Baylor College of Medicine, and RTOG
237 Case Report Forms
7697 variables (total)
More metrics on the CRFs, variables and modules will be posted on this page and the Project Metrics page.

CRF Project Wiki Child Pages

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