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Topic#

Question/ITEM

Response

1

What content must be CDISC CDASH compliant?

Initially, collected content that is part of a CTEP
  Integration.

2

What content must be CDISC SDTM compliant?

While not all data collected will need to be reported
  (e.g. safety data), all reported content as defined by the submission
  standard must be compliant .

3

What actions are needed (from an NCI perspective) if a Common
  Data Element (CDE) is not required by CDISC?

Leave CDE "as is"; submit a request/
  recommendation to CDISC for consideration to be added to CDISC Standards.

4

What actions are needed to make a 'partial match' CDE
  compliant with CDISC CDASH requirements?

Use the CDISC CDASH and SDTM guides to create a new CDISC
  CDASH compliant CDE.

5

 What fields need to
  match for a CDE to be CDISC CDASH compliant?

All fields should match all CDISC variables to minimize
  compliance issues during submission.

6

Does a CDE with no match to CDISC CDASH/ SDTM require
  manual creation based on the CDISC CDASH/ SDTM guides?

Yes; create a new CDE that matches the CDISC CDASH
  requirements.

7

What about the CDISC standards that are not geared towards
  oncology trials?

CDISC has developed 4 Oncology Standards:  Breast, Prostate, Colorectal and Lung.  NCI can propose additional domains as
  needed.

8

What is the burden of CDISC compliance on legacy trials?

 This does not
  impact legacy trials.

9

What is the burden of CDISC compliance on new trials?

NCI will follow FDA requirements.  Any required data being reported to the FDA
  for new trials needs to be CDISC compliant.

10

What is the potential impact to existing systems?

Unknown presently, NCI will be performing an Impact Analysis
  (IA) with current IT systems (e.g. OPEN, CTEP-AERS, CDUS)

11

How are potential differences between CDUS Complete
  reporting versus CDASH requirements to be managed?

NCI is aware of the various reporting requirements and
  these will be addressed during impact analysis and implementation activities.