Title: University of Chicago Protocol Review and Approval Process
1University of Chicago Protocol Review and
Approval Process Bethany L. Martell, Julian
Solway, Lainie Ross, Richard L. Schilsky, Susan
Cohn, Katie L. Arrigo, and Walter M. Stadler
The structure of the Clinical Translational
Science Award at the University of Chicago
includes four clusters with the Clinical Trials
Cluster focused on the execution of clinical and
translational research within the Biological
Sciences Division and the Medical Center.
Principal Investigators have generally perceived
the review and approval process to be overly
complicated.
- Assessing and redesigning the protocol routing
and approval process included efforts to identify
meaningful metrics. - Challenge What do we want to measure?
-
- The ease of the submission
- -This is very subjective
- The quality of the data submitted
- -This is also very subjective
- The speed of routing a new protocol through the
system - -When do we start the clock?
- Given the currently decentralized process, we
track processing time from three points - Schema to BAFO
- Schema to IRB Approval
- IRB Approval to BAFO
- -Schema reflects date PI determined designation
of charges - -BAFO (best and final offer) reflects date final
contract signed
PI PERSPECTIVE OF CLINICAL RESEARCH
INFRASTRUCTURE
Clinical Research Policy Board
University Research Administration
Conflict of Interest
Office of Clinical Research
Sectional/Programmatic Research Office
CTSA External Review
INSTITUTE FOR TRANSLATIONAL MEDICINE
Solway/Ross
CTSA Advisory Board
Office of Research Services
Office of Medical Center Compliance
INVESTIGATOR
IRB
ITM Executive Committee Director, Co-Director,
Assoc Directors Cluster Leaders, ANL and IIT
Reps Dirs of UCCRC, CCTS, CDPH, IDPH
Office of Clinical Research C/T Research
Support Office Subject Recruitment Core Research
Subject Advocacy
Community Connections Community-Based
Participatory Research Practice-Based
Research Knowledge Translation
Sponsor
Scientific Review Committee
CMS Private Insurance
FDA
Funding Agency
Community Translational Science
Cluster Ewigman/Gehlert
Clinical Trials Cluster Schilsky/Cohn/ Stadler
- For sponsored clinical trials the recommendation
has been for concurrent submission of - Regulatory and financial documents to the OCR
- IRB documents to the IRB
A snapshot of data from 2007
Population Sciences Cluster Thisted/Ross
Core Support Technology Cluster Weiss
Sponsored Clinical Trial Processing Time CY
2007 The following data reflect three aspects
of processing time for which the number of days
are considered. The numbers in the first 5
columns represent the occurrence of
protocol/contracts within the given time frame.
The last column reflects the average number of
days.
Training Cluster - Garcia (Meltzer/Olopade)
16 Patient and Wet Cores Core Technology
Incubator Pilot Collaborative Projects Internal
Sci Advisory Panel Biomedical Informatics Core
- The Office of Clinical Research (OCR) is the
support office for the Clinical Trials Cluster.
At the divisional level the OCR oversees various
components of clinical research including
regulatory, financial, human subject safety, and
institutional infrastructure. - The CTSA has served as a catalyst for assessing
the process by which we conduct the start up,
approval, and activities of clinical and
translational research. In particular the
following areas have been considered - Mapping current operations in the process of
protocol throughput - Identifying duplication and key stakeholders
- Designing streamlined and effective pathways for
improving the accuracy - and quality of submissions while decreasing the
time to review and approval. -
-
Does not include protocols without a contract.
Days reflect business days Schema
reflects date PI determined designation of
charges BAFO (best and final offer) reflects
date final contract signed
- Lessons Learned
- As we refine our metrics we would like to
consider how to obtain more comprehensive data
that will include all of the offices which are
involved in the execution of these processes.
To this end - We must have a well defined review and approval
process - We need to have buy-in from the process owners
- We need to measure what matters
- We need to act on the findings to improve the
process - We need to have accountability for the results
ideally by having the process owners report their
own metrics
- Challenge While this recommendation has been in
place for many years - There are no mechanisms to ensure that this
happens - Additionally, even if it did occur
simultaneously, the responsible offices do not
have formal procedures - for collaboration and integration of comments
and/or requested revisions
Our current and more streamlined proposal.
Division/Medical Center
University
Department
Human Subjects Protection (IRB)
Grants (ORS)
- Goals for the OCR
- Support the CTSA Clinical Trial Cluster
- Streamline clinical research operations
- Improve compliance with federal, state and local
regulations regarding clinical research - Educate and mentor research faculty and staff
- Provide infrastructure and tools for performing
efficient and high quality clinical research - Oversee development, implementation, and
reporting of internal and external metrics
Quality Assurance Education
S P O N S O R
Department Center/ Section (PI CRSO, CRC, or
budget/contracts, regulatory managers)
Financial and Administrative Regulatory Review
(OCR)
Contract Negotiations (URA)
OCR
IBC
Office of Clinical Research
RadRac
HIPAA Office
(G)CRC
IDS (Pharmacy)
Nursing Research
Pharm Sample RC
includes Core Support and Technology scientific
review which encompasses Clinical Resource
Center (formerly General Clinical Research
Center) groups which are external to the OCR
The OCR and IRB have merged and all submissions
will go to one division the OCR. All offices
within the circle are coordinated.