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
- Notify OnCore of the study's participant enrollment start date.
- Review the Clinical Study Process Guidelines for the ITA 2009
Dec 10, 2006 (if appropriate). - Schedule in-service for CTRU and infusion treatment area (if appropriate).
- Review Obtaining Informed Consent SOP
Nov 1, 2006 - Register participants with Patient Financial Services.
- Notify the pharmacy of each patient enrolled who will need investigational drug.
- Place all regulatory documents within study binder.
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
- Obtaining Informed Consent SOP Nov 1, 2006
- In-service Quick Reference Document 2008
- Clinical Study Process Guidelines for the ITA 2009 Dec 10, 2006
Trial Administration