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

Round 5 Spreadsheet

** The combined multi-tab reviewer spreadsheet is named 'Round 5 Reviewer Form MASTER 12.6.2013', and is attached here. 

Please refer to resources and information on the wiki to review the guidelines for review of this type document.  The far right column on each tab of the spreadsheet is the spot to add in your comments, questions, and recommendations.

CRF Round 5 Reviewer Form (Excel)

1. To help you with several elements that have extensive sets of permissible values, the green tabs in the spreadsheet detail some of the CDEs that appear in the modules. 

2. The RECIST v1.1 module is based on an extensive analysis of the NCI guidelines by a combined team from the NCI, FDA and CDISC.  We ask that you review this module to confirm the definitions are clear and precise.

3. There are some imaging modules included that need review and comment from our members who have biomedical imaging expertise.  If you feel you do not have that level of expertise in your organization, please feel at liberty to skip these modules.

4. The Diagnosis module included an element for MedDRA codes to describe overall diagnosis.  The element identified is the set of Simplified Disease Codes (SDC) used in CDS reporting.  If any group is collecting - not reporting - diagnosis data using other coding systems, we would like you to share that information on the reviewer form. 

5. Several modules use CDEs that include anatomic sites in the body.  We invite your recommendation on whether the same list of anatomic site codes should be used in every case of asking a question about an anatomic site.  The full list of values could be subset, but should the full list of values ALWAYS be the same?

If there are any questions about the review or the modules, please feel free to contact Dianne Reeves (reevesd@mail.nih.gov) or Neesha Desai (neesha.desai@nih.gov) for assistance.

Round 5 Timeline

The Round 5 Review 1 will start on Friday December 6^th, 2013 and end on Friday December 20^th, 2013.   If you find for any reason that you cannot complete the review by the end of December, please notify Dianne Reeves or Neesha Desai to advise us when to expect your comments.

The completed review sheets should be returned to Neesha Desai (neesha.desai@nih.gov) and Dianne Reeves (reevesd@mail.nih.gov).  If more than one person from an organization participated in the review, we would like those names for inclusion on this wiki.

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