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Off Treatment NCI CRF Standards:  Round 4

As in the Off Study module, this module has only three elements, all mandatory. The second element produced the highest number of responses in the review cycle. Again, reviewers were split between requesting additional reasons for being ‘Off Treatment’, and using a small number of reasons. This was another opportunity for integration with the ongoing Rave: caAERS integration going on now in NCI. Reviewers asked for the addition of reasons to the second data element in this module that were already in the CDE used for CDUS reporting, CDE 2453219. Therefore that CDE is going to be reused here. It is also a coded variable, which is most preferable to the LPOs instead of long text values.

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

Off Treatment NCI CRF Standards created on August 29th, 2012

Changed made from August 29th, 2012 to October 4th, 2013

ModuleCDECDE Public IDChange
Off Treatment  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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