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Summary Accrual

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Updates

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. 
   DO NOT CHANGE THIS SETTING IN ONCORE.
2. If your study is classified as being eligible for Summary accrual UploadsAccrual updates, please follow these instructions for required Quarterly uploads updates into OnCore, regardless of accrual numbers
   
   1. Classification will be determined by PRMC and determination is present in OnCoreProtocols menu > PC Console > Main > Details > Summary Accrual Info. Only = YES
      
      1. If this is not set to YESyou have questions regarding this setting, please contact your regulatory coordinatorPRMC.
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   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
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   4. Quarterly Accrual Schedule
      1. 1^st quarter schedule:  Enter enrollment information from January 1^st through March 31^st.  If your study opened to accrual during the 1^st quarter then use the open to accrual date as the “From” date. 
      2. 2^nd quarter schedule:  Enter enrollment information from April 1^st through June 30^th.  If your study opened to accrual during the 2^nd quarter then use the open to accrual date as the “From” date. 
      3. 3^rd quarter schedule:  Enter enrollment information from July 1^st through September 30^th.  If your study opened to accrual during the 3^rd quarter then use the open to accrual date as the “From” date. 
      4. 4^th quarter schedule:  Enter enrollment information from October 1^st through December 31^st.  If your study opened to accrual during the 4^th quarter then use the open to accrual date as the “From” date. 
      5. Quarterly summary accruals must be entered in OnCore by the 15^th of the month that follows the end of the quarter.
   1. 1. 1. 1^st quarter summary accruals will be due by April 15^th
         2. 2^nd quarter summary accruals will be due by July 15^th
         3. 3^rd quarter summary accruals will be due by October 15^th
         4. 4^th quarter summary accruals will be due by January 15^th

Adding Summary Accruals

1. Begin on on Home Page > Protocols menu > PC Console
2. Select a protocol by entering the protocol number in the "Select Protocol" field
3. Click the the Accrual vertical tab
4. Complete the following following Required Fields in  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 An entry of From 1210/1/2018, 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 Complete Race, Gender Biological Sex, and Ethnicity for each cohort (see table on next page for example)Gender and Ethnicity
      1. Biological Sex options are Male, Female, Unknown
      2. Ethnicity options are Hispanic or Latino, Non-Hispanic, or Unknown
      3. Race options are American Indian or Alaskan Alaska 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.
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      1. If the participant does not have a primary cancer diagnosis at the time of enrollment or the participant is a caregiver, provider, etc. then leave Disease Site blank.
   6. Complete other fields based on HRPO approved data collected

      1. "Age Group" options are 0-9, 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80-89, 90-99, 100+.  If age group is unknown, then leave blank.

      2. "Zip Code"- enter 5 digit numerical zip code in box. If zip code is unknown then leave blank. 

   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.

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*Institutional required fields marked in red, bold font