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Summary Accrual Uploads

How do I know if my study requires this?

  1. If you are unsure as to whether your Oncology study qualifies for Summary Accrual Info Only, please contact PRMC, as they make this determination.
  2. If your study is classified as being eligible for Summary accrual Uploads, please follow these instructions for required Quarterly uploads into OnCore, regardless of accrual numbers
    1. Protocols menu > PC Console > Main > Details > Summary Accrual Info. Only = YES
      1. If this is not set to YES, please contact your regulatory coordinator
    2. Summary Accruals are REQUIRED to be entered on a quarterly basis, beginning from date Open to Accrual through Closed to Enrollment.  Monthly entry is recommended.
    3. Enter enrollment information even if no enrollments have occurred in time frame being recorded

Adding Summary Accruals

  1. Begin on Home Page > Protocols menu > PC Console
  2. Select a protocol by entering the protocol number in the "Select Protocol" field
  3. Click the Accrual vertical tab
  4. Complete the following Required Fields in the "Add Protocol Accrual" block:
    1. Select "From" and "Thru" dates
      1. The From Date is the start date of this summary accrual entry
        1. If this is the first entry, this should be the date the study opened to accrual.
      2. The Thru Date is the end date of this summary accrual entry
      3. Entries must be grouped by calendar year.
        1. Only accruals occurring in the same calendar year can be grouped together.
        2. Example: an entry of From 12/1/2018, Thru 1/1/2019 is invalid.  Instead use Thru 12/31/2018.
    2. Enter "Accrual" number
      1. Accrual indicates the accrual number being recorded for this time period
      2. Enter the number of accruals (or specimens, entries, etc) for the specified period of time
    3. Select "Institution" and "Internal Accrual Reporting Group" from drop-down box
      1. The institution where the accruals being recorded occurred. Select the Institution responsible for recording the accruals.
    4. Complete Race, Gender, and Ethnicity for each cohort (see table on next page for example)
      1. Gender options are Male, Female, Unknown
      2. Ethnicity options are Hispanic or Latino, Non-Hispanic, or Unknown
      3. Race options are American Indian or Alaskan Native, Asian, Black or African American, Multiple, Native Hawaiian or Other Pacific Islander, Other, Unknown, White
    5. Select "Disease Site" from the drop-down box
      1. The Disease Site is the organ in the body where the patient's cancer first developed.
      2. The initial choices on the disease site drop-down are restricted to those that were entered when the protocol was created in OnCore.
      3. If patient's disease site isn't listed, contact the OnCore Support Team.
    6. Complete other fields as able, based on HRPO approved data collected
    7. Click "Add"
    8. Click "Close"
    9. Accruals will show in Accrual Summary box, and in study specific "Accrual to Date" headers


Summary Accrual Tracking Grid

The below resources can aid in entering in quarterly summary accrual information for your protocol.


 

*Institutional required fields marked in red, bold font

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