Summary Accrual Reporting for UAHS Clinical Trials

Summary Accrual refers to an OnCore function that reports the total number of participants enrolled in a clinical trial, using periodic updates to track research visits. This function differs from normal OnCore use, which involves detailed data about individual participants and complete calendar information to log visit history and procedure coverage.

Since OnCore serves as an enterprise system, all clinical trial investigators at UAHS are required to record and store their human subjects data in OnCore's database. In almost all cases, investigators must keep comprehensive information about their protocols, human subjects, and study calendars, with timely data input (within 24 hours) after every research visit to ensure Banner Health billing compliance.

However, Summary Accrual can be used in special circumstances, when OnCore's workflow features aren't needed for billing or regulatory compliance. Clinical trials that do not involve Banner facilities or billable expenses, and that utilize REDCap for their subject management, can be considered for Summary Accrual, using mimimum data (listed below) in OnCore. However, meeting those two criteria does not necessarily mean a clinical trial can or should be considered for Summary Accrual. Additional considerations include cohort size and enrollment processes. Generally, studies with large cohorts that do not involve the use of informed consent forms are more likely to be considered for Summary Accrual, especially if they are observational, retrospective, or banking studies.

In most cases the OnCore team will contact investigators whenever their initial review of a new protocol indicates that Summary Accrual may be advisable. Investigators are also welcome to contact OnCoreSupport@email.arizona.edu if they are interested in the Summary Accrual process for their clinical trials.

In every review for Summary Accrual accommodation, the OnCore team will reconcile the operational needs of a clinical trial with institutional priorities for enterprise data on research productivity and interaction with human subjects, as well as best practices for research ethics and regulatory compliance. As such, not all requests for Summary Accrual accommodation can be considered or granted.

Whether research teams are using Summary Accrual or the standard, full suite of OnCore management functions, the OnCore team provides training and one-on-one assistance by email and online office hours. OnCore team members are also available to attend departmental research coordinator meetings to provide information on OnCore features, workflows, and related Research Administration policies.
 


Minimum Data for Summary Accrual Studies

 

Minimum Subject Data

Consent Date/On-Study Date
Gender (Male, Female, Unknown)
Race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, Unknown)
Ethnicity (Hispanic or Latino, Non-Hispanic or Latino, Unknown)
Age Group (0-9, 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80-89, 90-99, 100+, Unknown)
Disease Site/Diagnosis (Optional, will use Diagnosis for protocol)
ZIP Code (Optional; if blank will use 85721)
Recruited By (Optional)

Minimum Protocol Data

UA IRB Number
Title
Investigator Initiated: Yes or No
Protocol Type (Basic Science, Device Feasibility, Diagnostic, Health Services Research, Other, Prevention, Screening, Supportive Care, Treatment)
Sponsor
Sponsor Number
IRB Approval Dates (Each time documents are submitted to the IRB, the OnCore team will need the IRB approval date; especially Continuing Reviews.)
Protocol Status and Dates (Open to Accrual, Closed to Accrual, IRB Study Closure)
Disease Site/Diagnosis

Minimum Staff Information

Principal Investigator
Primary CRC
Primary IRB Coordinator