Page History

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https://wiki.nci.nih.gov/display/CTRPdoc/Amending+Trials

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July 2020

Flexible Accrual: Enhanced the CTRP accrual reporting capabilities to include more “Flexible Accrual” reporting options.  Centers can now request to update the default accrual reporting type on a study registered in CTRP.  Changing the default accrual reporting type requires a ticket to be submitted to the CTRO (NCICTRO@mail.nih.gov) for review and approval, before any change is granted.

1. The current default accrual reporting types are as follows:

   Trial Type	Default Accrual Reporting Type
   Complete Interventional	Subject
   Complete Non-Interventional	Subject
   Abbreviated/Imported Interventional	Summary
   Abbreviated/Imported Non-Interventional	Summary

   
   

2. CTRP is also introducing a new accrual reporting type, “Partial Subject.”  Partial Subject accrual requires the reporting of Study Subject ID, Registration Date and Participating Site data only.  The other accrual data fields are optional.  The reporting of Partial Subject accrual also requires a ticket to be submitted to the CTRO (NCICTRO@mail.nih.gov) for review and approval, before any change is granted.
3. Accrual Data Element changes:
   1. Study Subject Birth Date: For any/all ways to report accrual, only the month and year (MM/YYYY) are required to be collected.
   2. Study Subject Country: Required for all methods of reporting accrual (was previously optional)
   3. Disease:
      1. Study Subject: Required
      2. Partial Subject: Not required. However, for ICD-O-3 Disease Codes if Disease is reported, then Site must be reported.
   4. Site: 
      1. Study Subject: Required
      2. Partial Subject: Not required. However, for ICD-O-3 Disease Codes if Site is reported, then Disease must be reported.
   5. Disease Codes: CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.

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