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• How are centers to count accrual for a participant who withdrew consent prior to starting treatment? Should these accruals be reported on the CTRP-generated DT4 report?

  • CurrentlyGenerally, National Sources count a patient a participant is counted as an enrollment/accrual once they have signed the consentInformed Consent Form, even if the patient withdraws at a later time.  The CTRP team will discuss this topic with the Office of Cancer Centers to provide additional feedback.  SW:  Susan is checking past minutes to see if this has been asked/answered to be consistent in the wording.However, this determination may vary across clinical trial protocols and each protocol should be reviewed for determining participant enrollment. 

• Will the Accrual API be affected by the switch to 2-part authentication?

  • The authentication will change but 2-factor authentication will not be required, as the API user will have a token with their authentication.

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