1. Research Methods - Regulatory Knowledge and Support
Alison Lakin, RN, LLB, LLM, PhD
CCTSI Research Methods
Core Director

2. CCTSI Organizational Structure

3. Regulatory One Stop Shop
Governance
Amy Gannon
AVC Finance incl.
Grants & Contracts
Regulatory One Stop Shop
Joanne Rupprecht, JD
Senior eIND Specialist

4. RKS Aims
Aim 1: Develop a multidisciplinary Study Jump-Start Clinic to improve the design and analysis rigor and ensure that ethics and regulatory aspects are responsibly addressed in clinical and translational research. (Shared with BERD)
Connect with Researchers at Pre- IND meeting, TIN consults, Perinatal Facilitation Committee
Connect when BERD has protocol design consult
Discussions with OGC to connect to Study Jump Start Clinic as soon as receive notice of award
Marketing as part of One-Stop Shop resources

5. RKS Aims
Aim 4: Promote an efficient, responsible and safe research environment across the lifespan of each study and facilitate improvements in the research enterprise to promote: Efficiency, Quality and Ethics
Efficiency:
All regulatory review timelines trending down
Start-up may be impacted by OnCore implementation
Greater transparency for research teams with Forte Insight

6. Aim 4: Efficiency: Start up Timelines
CTA Total
Contract Terms Finalized
SARC (Scientific Review)
Beacon Epic hospital
Total time to approval
COMIRB
(IRB)
Dept Budget Approval
Hospital review FY

7. Aim 4: Efficiency: Insight Tool – Activation Trends

8. Aim 4: Efficiency: Centralized One-Stop Shop for Regulatory Support
Regulatory Development
FDA Assistance
IND/IDE Application
FDA Annual Reports
ClinicalTrials.gov
Pre-Review
Human Research Portal
Pre-Review of Submissions
Consent writing assistance
Education
Clinical Trials training courses
Responsible Conduct of Research
Post approval study start-up assistance
Study Monitoring
Audits by request from study team
For cause audits
Study monitoring Committee
SUPPORT ACROSS THE LIFETIME OF A PROTOCOL

9. Aim 4: Efficiency: Participant Research Portal - Subject Information Portal (SIP)
clinicaltrials.ucdenver.edu

10. Aim 4: Efficiency: Initiatives with the Hospital Affiliates
CHCO
MSA (no sub-contracts) as of Spring 2018
Contracting office co-located with CU-AMC, UCHealth – language standardized
Single portal and OnCore – live as of Sept. 2018
DHHA
Single submission Portal as of January 2019
OnCore –Governance implementation plan approved to start early 2019
Denver VAMC
Contracting – agreed template for Federal and Industry collaborations
Renewing interconnectivity agreement
OnCore planning negotiations beginning

11. Aim 4: Efficiency: IRB Common rule changes:
- Implemented the time saving components in July – one of only 4 institutions to do so.
- As of December 1, 2018 – approved 800 protocols without an expiration – will monitor in OnCore instead
Developed an abbreviated Secondary Use application form for data and samples. Since October:
7/1/17 - 7/20/18

12. Aim 4: Efficiency: SMART IRB
COMIRB acting as Central IRB:
As of 11/28/18:
344 studies where COMIRB is lead IRB (mostly expedited research)
23 through Smart IRB
Using external IRB:
247 ceded to WIRB
69 studies ceded to another IRB
14 through Smart IRB

13. Biospecimen Protocols Biospecimen Individuals
Aim 4: Quality: Clinical Trial Management System- now active at UCHealth, CU Anschutz & CHCO
Current OnCore Data active in CTMS as of Dec. 1, 2018
UCH Metro
UCH North
UCH South
CU-AMC only
CHCO
Other
Total Count
CTMS Protocols
3,235
168
106
123
675*
429
4,736
Biospecimen Protocols 72 3 75
Biospecimen Samples
396,366
4,268
Biospecimen Individuals
19,068 94
19,162
* Aggregate CIC protocols for reporting only

14. Aim 4: Quality: Resources for FDA Investigator Initiated Studies
e-IND – first submission successfully completed for product manufacturing at CU-AMC, holding IND and conducting clinical trial
Training for PI, coordinators:
Use of case report forms and system based monitoring in OnCore – being used for investigator initiated studies across UCHealth
Generating new innovative tool for analyzing data going from
AgileMD>EPIC>Compass>Eureka>Clinical Trial data capturing form – prototype is now being tested
2018
OnCore Trainings
Date
# Attendees
Financial
217
Subject
576
Biospecimen 80
2018
ACRP PI Training
Date
# Attendees
6/29/2018 5
11/6/2018 4
2018 Coordinator
ACRP CRC Boot Camp
Date
# Attendees
6/18/18 - 6/22/18 21
8/20/18 - 8/24/18 20
CRSC Trainings
Date
# Attendees
22 courses
1370
Consults 22

15. Aim 4: Quality: Recruitment Data
TriNetx – to assist with study design and feasibility
CCTSI Study Monitoring Committee oversight expansion
Expanded membership to include diverse expertise and experience
Scope broaden to include CU-AMC protocols with IRB approval
Tools: OnCore, Insight
Use of Compass for recruitment across UCHealth – process approved by IRB
CHCO registry for recruitment using Epic in development

16. Aim 4: Quality: OnCore Insight Recruitment Tool
Provides a list of protocols and indicates their level of recruitment based on original recruitment plan
Data available to the Study Monitoring Committee

17. Aim 4: Ethics: Teaching/Training
Investigator Initial Research Ethics Consults
Consults focused on Dep Brain Stimulation (DBS) for sleep in Parkinson’s patients and DBS for cocaine addiction.
Teaching Research Ethics Session for all 1st year medical students and 23 facilitators
Collaboration on RCR classes.
CLSC 6260 – Conducting Clinical Trials for Investigators
In-services for nursing staff in regulatory/ethical issues

18. Aim 5: Develop, adapt and disseminate innovative research tools using a regulatory science framework to promote competency
Collaborative Goals with Dissemination, QPIP and Eval across cores:
Design a centralized, systematic, efficient process and infrastructure for clinical trials recruitment in collaboration with resources such as ThreeWire
Ensure the solution is designed for dissemination and sustainability by a) engaging study teams in the development, and b) establishing the value propositions and revenue generation model
Engage the services and resources of multiple CCTSI programs and cores to demonstrate novel integrative use of CCTSI resources
Actively disseminate the solution and methods for designing the solution across the CTSA network
From Research team perspective
From Participant’s perspective

19. Aim 5: Defining Success for Research Team
Investigator Enrollment Performance (by Quartile)

20. Aim 5: Recruitment Project
Overview and Timeline
Step 1:
Summer/Fall ’18
Step 2:
Fall/Winter ’18-’19
Step 3:
Spring/Summer ’19
Step 4:
Beyond
Designing for Dissemination
Training Completed
QPIP
Develop logic model Define Tool Kit in progress
I-Corps,
Team Science Training
Dissemination and Scale-Up (Cross CTSA)
Evaluation

21. Aim 5: Dissemination 9th Annual Research Ethics Conference
Title: Risky Research: What Keeps You Awake at Night?
October 25, 2018, 12-4pm
97 attendees including: students (9%), PRAs (23%), Faculty (20%), Staff (46%)
Annual Hospital Wide Ethics Grand Rounds:
Title: Appropriate Retention Strategies in Clinical Research: Where do we cross the line from retention to coercion?
Presenters: John Heldens and Marilyn Coors

22. Aim 5: Dissemination
DSMB Manual published May 23, 2018 on Tufts CTSA website (Barbara Hammack)
Has had 1,408 page views since website launched
Visitors spend an average of 3 minutes and 46 seconds on the page
DSMB Training Videos under development based on the Manual
Curriculum developed for videos follows chapter headings of manual
Currently being determined: format, software, platform to post videos on, certification
CCTSI involved primarily in developing videos for chapter 5 (data and safety review process) and chapter 6 (role of a study safety officer and study monitoring committees)

23. Research Methods Publications:
Aim 5: Dissemination
Research Methods Publications:
“The Emergency Medicine Specimen Bank: An Innovative Institutional Collaboration to Personalize Acute Care” - Acad Emerg Med Sep 21
Conducting Clinical Research in Post-Acute and Long-Term Nursing Home Care Settings: Regulatory Challenges – in collaboration with PACRATS – submitted to JAMDA
Manuscript from prior investigator initiated research ethics consult: “Ethical duties when a statewide, anonymous student health survey finds high suicidality in a school” - submitted to: American Journal of Public Health

24. Questions for EAC
How have you been able to ensure that research teams access resources at the appropriate point in the process?
How else are you using the data in OnCore to improve the quality of research conducted at your institution?