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Off Study NCI CRF Standards:  Round 4

The off study module has only three data elements, all mandatory. There were many comments about adding to the variable that collects the reason off study. The comments were split between asking for very specific, granular reasons that increased the list of reasons significantly, and the recommendation that we use a small set of reasons with the ability to use ‘Other’ to capture descriptive content. This is one area in which we were able to harmonize this content with the elements used for CDUS reporting. We worked with CTEP to identify the elements they are using to capture off study, and compared those elements to the reviewer comments. CTEP agreed that simply reusing the existing coded element for ‘Reason Off Study’ would meet the needs of our community and would support Rave integration with CDUS reporting. That element is in the final set.

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Off Study NCI CRF Standards created on October 4th, 2013

Off Study NCI CRF Standards created on January 18th, 2013

Changes made from January 18th, 2013 to October 4th, 2013

ModuleCDECDE Public IDChange
Off Study  

Updates made based on finalized community review process

Status

status diagram showing pilot status

Metrics

CRF Stars:  Working Group Membership

* Represents working group leads

No.

First Name

Last Name

Affiliation

1MehdiAdinehACRIN
2StephanieClaboACRIN
3CCobbACRIN
4LindseyDymondACRIN
5GlennaGabrielliACRIN
6JincyGeorgeACRIN
7PamHarveyACRIN
8DavidHillmanMayo - NCCTG (Statistician)
9AnthonyLeveringACRIN
10QuentinMcMullenACRIN
11BevMeadowsNCI - DCP
12RikiOhiraBAH
13AdamOpanowskiACRIN
14DianePaulPatient Advocate
15DianneReevesNCI - CBIIT
16TheresaRoyce-WestcottUniversity of Michigan
Manager of Clinical Trials Office
17DanSargentMayo - NCCTG (Statistician)
18KeshaSmithACRIN
19TinaTaylorACRIN
20DanielleZieglerACRIN
21LizNessNCI - CCR
22ShandaFinniganNCI - CTEP
23BobMiliusUniversity of Minnesota
caBIG Delployment Lead
24OlivierSaulinMDS Pharma Services
25AnneRyanNCI DCP
26BrendaMaeskeSAIC
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