Who is the UC Quality Assurance and Regulatory Compliance Specialist?
100
Calgary Centre for Clinical Research (CCCR)
What UC center provides clinical trial finance support?
- training on clinical trial budgeting (process, price lists)
- budget review
- training on clinical trial finance processes
- clinical trial finance tools
100
PRA
What AHS department deals with data access and operational approvals?
- PRA (Provincial Research Administration)
100
Participate
What is the name of the UC Research Portal?
200
N2 Standard Operating Procedures (SOPs)
What SOPs are reviewed bi-annually for regulatory compliance?
Compliant with Health Canada and US FDA regulations, the ICH-GCP Guidelines, including the current changes to ICH-E6, and the revised Canadian Tri-Council Policy Statement on Research Involving Human Subjects.
200
AR and RA
What UC departments support clinical trial accounting?
-Accounts Receivable (AR)
-Research Accounting (RA)
200
5 month backlog
What was the PRA backlog for issuing AHS approval in November 2016?
- >200 UC studies were backlogged, no triaging, sequential process
- UC assisted with clearing the backlog and developing faster "lighter touch" process.
- legacy: 102 days to approval, now: 18 days to approval
200
Adam Kirton
What is the name of the “Participate” Launch PI?
300
CITI training
What clinical training courses can be taken free of charge through the UC?
-Good Clinical Practice (GCP)
-Health Canada Division 5
-Responsible Conduct of Research
300
Insufficient budget, lack of finance tools and lack of finance training.
What are the main reasons for a project account to be in a deficit?
300
UC-AHS Data Access Agreement
Which agreement was reached between AHS and UC in March 2017?
- outlines UC responsibilities for ensuring the PIs and research staff comply with HIA and FOIPP.
- foundation of "lighter touch" approval process (data elements no longer listed & only one AHS signature on research agreements).
300
Research requiring human participation
What studies will be included on the UC Research Portal?
400
SOPs, HIA, FOIP, TCPS2, Health Canada, GCP, US FDA
What are regulations, guidelines, and policies governing clinical trial?
400
$3 Million
What amount of unallocated payments does the UC have at any given time?
- need for better accounting processes
- suggestions: dummy invoices for automatic payments, inclusion of project code in CT agreement, central tracking through CCCR
400
28% non-response rate
What is an ongoing challenge for PRA when processing data access and operational approval requests?
- 28% of PIs/coordinator don't respond to PRA emails
- Increases PRA response time
- Next step: use of IRISS for collecting info needed by PRA
400
Study advertising, community outreach, faster study completion times
What benefits does Participate offer to researchers?
500
-Guiding research teams through the regulations and guidelines governing clinical research
-Assisting research teams with regulatory file organization
-Preparing research teams for Health Canada inspections
-Providing SOP support
-Conducting QA/GCP compliance file reviews
What does the UC QA program offer?
500
Clinical Trial Management System
What would help with the finance management of clinical trials?
- tracking of visits
- tracking of invoicable items
- invoice generation.
500
Student Research Proposals
What study proposals are particularly impacted by AHS approval delays?
- students have a limited time window and rely on timely approval of their projects.
- supervisors can assist with ensuring that proposals are well planned and complete
500
10%
What percentage of all UC studies is currently included on the Participate Research Portal?
- need more PIs to advise their coordinators to post all their studies involving human participation.
- need leadership to encourage participation.