Clinical Research Periodic Reviews and Tasks

Monthly

Study Type Responsible Party Task Notes Application(s) (If applicable)
All Study Team Reconciles research transactions/UKHC billable services It is recommended that this process occurs at least every two weeks | See Contact List if corrections are needed Epic statements, reports, RWB, and Slicer Dicer | Tableau | OnCore
All Study Team & Collaborative Grant Services Perform reconciliation in SAP of all expenditures including any hospital and/or professional bills from participant research accounts Includes salary, travel, patient care, supplies, research subject payments, etc. Tableau
All Study Team Charge effort for faculty & staff CDEM or STEPS

At Least Quarterly

Study Type Responsible Party Task Notes Application(s) (If applicable)
Study coded as Grant Type HC or H0 in SAP Study Team Invoice sponsors for all completed work See University Financial Services for accounts receivable compliance site; AR recorded for studies by RFS based on OnCore report; AR recorded by RFS for studies outside of OnCore based on information from CRSO SAP
Study NOT coded as Grant Type HC or H0 in SAP RFS & Collaborative Grant Services Invoice sponsors for all completed work See University Financial Services for accounts receivable compliance site SAP
Summary Accrual study in OnCore Study Team Enter accrual data into OnCore See CRSO Training Resources OnCore

Quarterly

Study Type Responsible Party Task Notes Application(s) (If applicable)
All Study Team Complete payroll confirmation See University Financial Services for payroll confirmation site

Annually

Study Type Responsible Party Task Notes Application(s) (If applicable)
Investigational Drug or Biologic IDS Team Complete Non-IDS-Managed Study QA and report results to the Study Team and the ORI This must be done at least annually but can be done more often if desired
NIH Funded Study Team & Collaborative Grant Services Complete IND Maintenance and Annual Report See nvestigational New Drug (IND) Application for details and instructions
Multi-year studies Study Team END OF FISCAL YEAR: Transfer funds to the next fiscal year

Within 90 Days of Annual Expiration

Study Type Responsible Party Task Notes Application(s) (If applicable)
All Study Team Follow instructions for Annual IRB Renewal See Continuation Review (CR)/Annual Administrative Review (AAR)

At Least 1 Month Before Annual Expiration

Study Type Responsible Party Task Notes Application(s) (If applicable)
Investigational Device Study Team Contact Renee Hensley (Payer Administration) to request renewal paperwork
Investigational Device Study Team Update UKHC Value Analysis on study status

90 Days Before the Study Closes

Study Type Responsible Party Task Notes Application(s) (If applicable)
All Study Team Notify everyone involved (clinic(s), operations, Finance, Revenue Integrity, Revenue Cycle, etc.) that the study is closing