Page History

CRF Round 5

Status

The fifth round of NCI Case Report Form (CRF) Harmonization and Standardization activity has been completed, and is ready for formal community review.  Your feedback is invited at this point, to prepare the content for community adoption and implementation. 

Please mark your calendar!!! 

The two week review period for this content will begin after Thanksgiving, on Friday December 6^th, 2013 and conclude by close of business Friday December 20^th, 2013. 

The following content will be included in the Round 5 formal Community review: 

CRF Initiative Round 5 activity was convened in December of 2013.  Content identified from candidate CRFs and from the community was placed through iterative and large-scale community review for approval as NCI eCRF data collection standards.  Content in Round 5 was delivered from the following workgroups:

• Diagnosis/Pathology – total of four modules
• Imaging – total of three modules
• RECIST Activity – total of one module
• Response/Procedures and Results – total of two modulesImaging
  
• CT Image Acquisition
• CT Image Administration
• CT Image Agent
RECIST
• Survival/Death/Follow-up
  
  • Lost to follow-up
  • Survival
  • Follow-up
  • Progression
• Response/Procedures/Results
  
  • Response
  • Procedures/Results
• Diagnosis/Pathology
  
  • Diagnosis/Pathology
  • Gross Tumor
  • Metastasis
  • Microscopic Histology

Round 5 Spreadsheet

Round 5 Timeline

The Round 5 Review 1 will start on Thursday December 6^th, 2013 and end on Friday December 20^th, 2013.

Calendar

Round 5 Comment Tracking Log

• – total of two modules

Multiple lead protocol organizations (LPOs), cancer centers, universities and community groups contributed to content, review and finalization.  After input from the community was received, the prescribed changes to the 12 modules of content began.  This work required the help of multiple curators since the standard elements come from a number of registry contexts.  Changes and in some places new CDEs were needed.  Once all changes to CDEs were made, the CRF modules were reviewed and revised, then validated again before being released.  The final step is a load of the standard templates into the NCI Standard form cart in the caDSR. 

By the close of June 2018, all changes to Round 5 content were completed and reviewed by the NCI CBIIT curation team.  CRFs were built in caDSR then the FormBuilder Form cart and CDE cart were updated along with this Wiki. 

• Diagnosis/Pathology
  • Diagnosis
  • Diagnosis Gross Pathology
  • Diagnosis Metastasis
  • Diagnosis Microscopic Pathology
• Imaging
  • CT Image Acquisition
  • CT Imaging Agent
  • Image Administration
• RECIST
• Response/Procedures/Results
  • Progression
  • Response
• Survival/Death/Follow-up
• Follow-Up/Survival
• Lost to follow-up
  
  

Summary of NCI CRF Round 5 Harmonization Efforts - Mandatory, Conditional and Optional Statuses

Working Groups Main Page