Participant Enrollment
Opening a Study to Accrual
Once all the proper approvals and issuances are in place, the study can be opened to patient accrual. These items include:
Approvals
- IRB
- SRC
- CTRU (if applicable)
- FDA (for investigator initiated studies only)
Issuances
- Notice of Award (NoA) (for sponsored research only)
- Project Task Award (PTA) account
- 098 or Mnemonic account (if applicable)
Once a study is ready to enroll
- Inform OnCore of the date the study will start participant enrollment by emailing ccto-protocol@stanford.edu.
- Schedule in-service for clinic and infusion treatment area (if appropriate).
- Review Obtaining Informed Consent SOP.
Notice of Award (NoA): an internal document issued by the Office of Sponsored Research (OSR) which includes a signed contract along with an internal budget.
Project Task Award (PTA) account: This account is issued by the Office of Sponsored Research (OSR) which is similar to a bank account.
98 Account: This account is issued by Stanford Hospital and is used to charge hospital related procedures to the study.
Mnemonic Account: This account is issued by Lucile Packard Children’s and is used to charge hospital related procedures to the study.
Resources
Trial Administration