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• What is the location on the Wiki to download ICD-O-3 code lists when there are updates?
  • The lICDICD-O-3 code lists can be found at this link: https://wiki.nci.nih.gov/display/CTRPdoc/Accrual+Data+Elements+with+CTRP-Accepted+Values+for+Complete+Trials
• The number of observational studies without an NCT number is likely to be extremely high. Why are these being treated as one-offs?
  • The one-off situations referred to here are only for industrial trials (not an Investigator Initiated or National Trial) that would be traditionally imported from ClinicalTrials.gov.  For these instances where an NCT ID is not available, the CTRO currently has a mechanism to get the trial into CTRP, but this mechanism may be updated based on the scope of trials.

• How often, if ever does CTRP run a comparison of Center CTRP data against CT.Gov? I ask as we've had a recent issue where we are not the lead organization for an IIT, but our internal data matches that of CT.Gov. It does not, however, match CTRP and has created an inconsistency in our report.
  • We do not formally compare all data between CTRP and ClinicalTrials.gov.  For imported studies, we look at ClinicalTrials.gov to be the source of the trial level data.  For non-imported studies (IIT and/or National studies), we look to the data submitter to provide any trial level data and updates.  On an
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• • adhoc basis, the CTRO may contact the lead organization if there is an obvious reporting issue.

    
    

• Can David also speak to how centers are to count a withdraw of consent prior to starting treatment? Should these count as an accrual reportable on the DT4?

  • David to follow-up.  

    
    

• David, will API be affected by the switch to 2-part authentication?

  • The services should be updated and our team will confirm that any change will not affect users.

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