We are collecting accrual data to enhance our ability to develop performance improvements that increase planned subject accrual into clinical studies.

Reports will be sent to IU and IU Health senior leadership as well as NIH.

Data will be collected from OnCore for all studies open to accrual during a specified timeframe, typically quarterly or annually. Data will be reported at the individual study level, in aggregate at a departmental/division level, and at the enterprise level.

The following data will be reported from OnCore for each study:

• • Number of subjects accrued
  • Number of subjects targeted for accrual
  • Number of days elapsed since the study was opened to enrollment or number of days the study was actually open.
  • Number of days the study is estimated to enroll subjects

• • Check the protocol for enrollment timeline
  • Determine if enrollment for the protocol has just begun or will IU/IUH begin enrolling midway through the enrollment timeline
  • Take into consideration where enrollment is at in real time    
  • Consider the time it will take to reach the RC Total Accrual Goal (Lower) field in OnCore

• • Along with Affiliate Accrual Goal, the RC Total Accrual Goal (Lower) should be entered. The RC Total Accrual (Lower) goal may be duplicated from the Affiliate Accrual Goal.
  • See Question below: What standard fields are required to be completed in OnCore?

Protocol No.
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)

Title
The full-length Title as listed on the protocol document.

Principal Investigator
The Principal Investigator is the PI of record at the IRB.

Department
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.

• • The number of subjects accrued can be based on either individual subject registrations or summary accruals.
    
    
    • • Summary Accrual Info Only? Protocols must have accrual numbers entered quarterly (i.e. January 1-March 31, April 1-June 30, July 1-September 30, October 1-December 31)
      • Studies with individual patient registration must ensure all enrolled subjects have an On Study Date in order for the numbers to count.
        
        
  • Summary Accrual data may not be on the report based on the time the report is generated (i.e. reports run on May 31st will not include 2nd quarter accruals).

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

By looking at Accrual Ratio, we can determined if accrual is ahead of or behind schedule. An Accrual Ratio below 100 would infer you were behind schedule, while an Accrual Ratio greater than 100 would infer you were exceeding expectations.

Note that this calculation assumes a linear rate of accrual over the enrollment period. While accrual may not happen in a linear constant manner, this is viewed as a reasonable way to approximate the current accrual ratio for a study. An example of non- linear accrual may include trials with intermediate, planned holds on accrual for interim evaluation.

Data will be collected quarterly, typically the first of each month following a quarter.

If IU is leading the multi-site study, accrual from all sites should be included. Accrual numbers should be listed under the appropriate enrollment sites within OnCore.

If IU is only participating in the multi-site study, only accrual from IU and its local affiliates should be included.

All accrual should be entered and assigned to the appropriate enrollment sites within OnCore.

If your research team requires additional training on the entry of accrual data into OnCore – please contact us at oncore@iu.edu to attend an upcoming training session. If you have questions regarding the accrual metric, please contact the Office of Clinical Research at ocr@iu.edu.