The unique identifier for the protocol. It should be formatted as follows: Acronym for Primary Management Group-Sponsor-PI-Short Title for study (i.e. GI-ROCHE-EINHORN-BETA)
The full length Title as listed on the protocol document.
The Principal Investigator is the PI of record at the IRB.
Department identifies the department or division associated with the principal investigator of record at the IRB.
DT4 Report Type (Cancer Center Only)
DT4 Report Type may be Ancillary or Correlative, Interventional, Observational or Not Applicable. Refer to definitions on the IUSCC intranet site for more details.
Protocol Type (Cancer Center Only)
For Cancer Center studies Protocol Type may vary based on Interventional or non-Interventional protocols. Refer to definitions on the IUSCC intranet site for more details.
Protocol Type (non- Cancer Center)
Protocol Type may be Interventional, Observational or Expanded Access. Refer to definitions for the Minimum Standardized Requirements for Protocol Entry found on the OnCore Training & Support page. Protocol Type should match the Study Type listed in ClinicalTrials.gov.
Open to Accrual Date
Open to Accrual Date is the date on which the institution is open to accrual/enrollment. This means all required reviews are complete, sponsor authorization obtained, and the research group is fully prepared to begin seeing patients. This date may be on or after the IRB Initial Approval Date.
Accrual Duration (Months)*
Accrual Duration (Months) estimates the number of months you plan to locally enroll patients or participants on the study. This may not be the accrual duration listed within the protocol document.
RC Total Accrual (Lower)*
RC Total Accrual Goal (Lower) estimates the minimum number of subjects you plan to enroll locally. The RC Total Accrual Goal (Upper) data can be duplicated in this field. NOTE: Studies that have “open enrollment” where there is no set accrual goal, the RC Total Accrual Goal (Lower) field must be updated quarterly.
*Can be updated as needed to match the current status of the study.
This metric is the ratio of the following 2 percentages:
- Accrual Percentage (the actual number of subjects enrolled divided by the number of subjects targeted by the completion of the trial, multiplied by 100 to get a percentage)
- Percent of Accrual Period to Date (the actual number of days elapsed since the study opened to enrollment divided by the expected number of days the study will be open to enrollment, multiplied by 100 to get a percentage).
**Accrual Ratio = Accrual Percentage/Percent of Accrual Period to Date x 100