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

CRF Modules

Round #

Current Status of Module

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 InterventionInterventions

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 Agents

3

Final

  • Total of 13 CDEs built in one CRF standard module.

Consent

4

Under Review

  • Draft New CRF standard module undergoing community review and vetting.

Demography Demographics

1

Final

  • Total of 15 CDEs built in one CRF standard module.

Diagnosis and Pathology(Administrative)

4

Under Review

  • Draft New CRF standard module undergoing community review and vetting.

Diagnosis (Intervention)

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

Under Review

  • Draft New CRF standard module undergoing community review and vetting.

Drug AccountabilityCompliance

3

Internal Harmonization complete; Expanded Committee Review in session.

Eligibility Criteria

4

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

Under Review

  • Draft New CRF standard module undergoing community review and vetting. |

    End of Form

    3

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  • Final

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  • Total of 8 CDEs built in one CRF standard module. |

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  • Final

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  • Total of 5 CDEs built in one CRF standard module. |

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.

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