Clinical Trials (Post Award and CRMS) Dorothy Damron, Oncology Research Manager and CRMS Lead Scott Streibich, Clinical Research Revenue Cycle

Transcription

1 Clinical Trials (Post Award and CRMS) Dorothy Damron, Oncology Research Manager and CRMS Lead Scott Streibich, Clinical Research Revenue Cycle 1

2 Objectives Key CRMS Functionality for Financial RAPs Centralizing data and documents Using data to make decisions Monitoring Key Dates Monitoring Enrollment Goals/Milestones Where CRMS Links to Research Billing Epic 2012 Legacy systems 2

3 CRMS is: Clinical Research Mgmt System (CRMS) Web-based Role-based Only see your studies based on eirb Financial Admin can have Departmental rights Accessed using JHED ID and password Interfaced with e-irb (study information) Interfaced with Epic (Patient Demographic data to CRMS; CRMS study info to Epic)

4 When Is CRMS Used? All studies with a Prospective Reimbursement Analysis (PRA) must use CRMS Optional (but recommended) for Non- PRA studies Every research coordinator becomes a database developer when they leave the position, the study team starts over

5 CRMS and the Financial Process Prospective Reimbursement Analysis (PRA) Budget Development, Negotiations, Contracts IRB Approval (and other key dates) Authorization for Insurance Clearance Participant Enrollment Tracking Case Report Forms (multi-site) Study Calendar (milestone billing) Tracking Study Documents Key: In Use In Development Not Applicable

6 Clinical Trial Financial Management Challenges How CRMS Can Help 10/28/2013 6

7 What Studies Are Being Done: Department? Division? PI? Access information by using default list or search functionality 10/28/2013 7

8 Who is Responsible for the Study s Finances? IRB-approved Study Team Members The Financial Manager can be added to the Study Team Tab in CRMS 10/28/2013 8

9 How are NA_ , , and 50CA Related? They are all tracking numbers for the Same Study! In CRMS you can store this information to find it all in one location. 10/28/2013 9

10 Does the Study have a PRA? What Type of Insurance Clearance? CRMS Regulatory Tab 10/28/

11 Is Insurance Clearance being Submitted Per Institution Policy? Insurance Clearance Status 11

12 Are We Opening/Closing Studies in a Timely Manner? 2 months from Depart. Review until IRB Approval not too bad 4 months from IRB Approval until Open for Enrollment Date Closed and Reason Closed 10/28/

13 Are people going on study? Will we break even? Is this study on target NO!... Would expect study to be over based on 2010 Activation Date and Accrual projections. 10/28/

14 Are we getting reimbursed for screen failures? Tracks Screen Failures (Not Eligible) on Enrollment Tab Summarizes Information on the Sponsors Tab 14

15 Store Study Documents Active, Draft and Archived Documents with history 10/28/

16 Documenting Milestones Ability to enter subject progress on the Enrollment Tab. Use this information for tracking milestones at Hopkins and other sites (you may owe them for enrolling patients). 10/28/

17 Meeting Critical Mandated Reporting Requirements! This information can be pulled from CRMS easily! 17

18 In Dev: Build the PRA to Create the Budget Rules for study accuracy Notes for the study team Billing information per PRA 18

19 CRMS and Epic Linkage 10/28/

20 The Research Hold Research Hold CRMS CRMS Active Status Hold in Keane CRFC Submitted CRFC Hold in Resolute IDX Based Holds Profee and Meditech (JHBMC)

21

22 Why CRMS Use is Critical: Quickly Identify who is on a Study Candidacy: Candidate: the person is a potential candidate for the study. Not Candidate: the person is a no longer a candidate Consented the person consented for the study Record what version of the consent was signed Record who consented Record date consented Eligibility: Eligible or Not Eligible

23 Why CRMS Use is Critical: Quickly Identify who is on a Study Enrolled Document progress of the participant on the study Follow up Start Intervention/Treatment date No longer receiving interventions but following for some defined period of time per the protocol (survival) Off Study Patient no longer affiliated with the study

24 Why CRMS Use Is Critical: Contains Real-time Study Data Billing Compliance Needs to Make Decisions Based on this information

25 Institution s Billing Process: Maintain Real-time Data Keep the following information up-to-date in real time : Consent Date On Study Date Start Int (Intervention) Date Last Int (Intervention) Date End Int (Intervention) Date Off Study Date Institution Policy: Must update within 3 business days Billing Compliance is making important decisions based on the information you put in CRMS!

26 Questions? CRMS Questions: CRMS: Clinical Research Billing Questions: Scott Streibich /28/