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CRF Harmonization and Standardization

 

Contents of this Page

Module Status Table

** Modules are alphabetized

** Content that is marked Final is ready for use.  Content that is marked Under Review is candidate status and is available to use but please note that this content could change in the final release.

CRF Modules

Round #

Status

Status Description

Adverse Events

2

Final

Total of 31 CDEs built in two CRF standard modules – one to use with CTCAE v3.0 reporting requirements, and one for CTCAE v4.0 reporting requirements. AE modules include Serious Adverse Event (SAE) CDEs.

Base Interventions

3

Not Needed - Removed

The intent of the Base Interventions module was to group all commonly-used CDEs need for primarily intervention studies.  In one module CDEs for start date, stop date, dose, Unit of measure, dose, etc., were grouped.  Reviewers did not feel this was the best way to categorize the elements.  So the pertinent elements in the Base Interventions module were instead added to each intervention/agent module.  The Base Interventions module is retired, and not part of the final Standard CRF set.

Concomitant Medication

3

Final

Total of 13 CDEs built in one CRF standard module.

Consent

4

FinalTotal of 6 CDEs built in one CRF standard module.
CT Image Acquisition5Under Review 
CT Imaging Agent5Under Review 

Demography

1

Final

Total of 15 CDEs built in one CRF standard module.

Diagnosis (Administrative)

4

Final

Total of 8 CDEs built in one CRF standard module.

Diagnosis (Intervention)

4

Final

Total of 6 CDEs built in one CRF standard module.
Diagnosis5Under Review 
Diagnosis Gross Pathology5Under Review 
Diagnosis Metastasis5Under Review 
Diagnosis Microscopic Pathology5Under Review 

Drug Compliance

3

Not Needed - Removed

Review demonstrated that 5 of the 8 CDEs in this module are repeated in the Study Administration CRF module.  So the remaining 3 CDEs were merged with the Study Administration CRF standard module, and the Drug Compliance module removed as a separate CRF module.

Eligibility

4

Final

Total of 8 CDEs built in one CRF standard module.

End of Form

3

Final

Total of 8 CDEs built in one CRF standard module.

Enrollment

2

Final

Total of 5 CDEs built in one CRF standard module.

Equipment

4

Final

Total of 10 CDEs built in one CRF standard module.
Follow-Up5Under Review 

Footer

3

Final

Total of 5 CDEs built in one CRF standard module.

Header

3

Final

Total of 11 CDEs built in one CRF standard module.
Image Administration5Under Review 

Image Quality

4

Final

Total of 7 CDEs built in one CRF standard module.

Laboratory Tests and Results

3

Final

Total of 14 CDEs built in one CRF standard module.
Lost to Follow-up5Under Review 

Medical History

2

Final

Total of 7 CDEs built in one CRF standard module.

Outcome Measures

3

Not Needed - Removed

The outcome module was created in round 2.  At the time of delivery the limitations in the content were recognized, and we had a plan to expand the content at some point and also look mainly at response results in nonsolid tumors, like the leukemias and lymphomas.  So round 5 was envisioned as expanding two main areas in round 2 – 1) responses had to be expanded beyond the solid tumors, and 2) survival had to be expanded.  Therefore, Outcomes in round 2 have now been replaced by content in round 5.  

Off Study

4

Final

Total of 3 CDEs built in one CRF standard module.

Off Treatment

4

FinalTotal of 3 CDEs built in one CRF standard module.

Participant Identification

2

Final

Total of 10 CDEs built in one CRF standard module.

PET Emissions Scan

4

Final

Draft New CRF standard module undergoing community review and vetting.

PET Equipment QC Assessment

4

Final

Total of 2 CDEs built in one CRF standard module.

PET Imaging Agent

4

Final

Draft New CRF standard module undergoing community review and vetting.

PET Patient Prep

4

Final

Total of 7 CDEs built in one CRF standard module.
Progression5Under Review 

Physical Examination

2

Final

Total of 6 CDEs built in one CRF standard module.

Prior/Post Therapy Agents

3

Final

Total of 14 CDEs built in one CRF standard module.

Protocol Deviations

2

Final

Total of 8 CDEs built in one CRF standard module. The use of a Protocol Deviation module is NOT recommended. Deviation data should be recorded in the appropriate form (agent administration, AE, etc.). However, if a sponsor mandates the use of an additional Protocol Deviation module, the identified variables should be used.

Radiation Therapy

4

Final

Total of 30 CDEs built in one CRF standard module.
RECIST5Under Review 

Registration

2

Final

Total of 19 CDEs built in one CRF standard module.
Response5Under Review 

Screening

4

Final

Total of 4 CDEs built in one CRF standard module.

Staging/Extent of Disease

3

Final

Total of 21 separate CRF modules for major disease groups, including Leukemia, Lymphoma, and Solid tumors. There is no generic stage CRF module content. All CRF modules begin with ‘Staging’ and then have the specific diagnostic group. CDEs in these modules are largely but not exclusively based on AJCC edition 7.0 collaborative staging criteria.

Study Agent Administration

3

Final

Total of 19 CDEs built in one CRF standard module.

Surgery

4

Final

Total of 31 CDEs built in one CRF standard module.
Survival5Under Review 

Vital Signs

4

Final

Total of 24 CDEs built in one CRF standard module.

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:

CRF Standardization Process diagram

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