UNIVERSITY OF CALIFORNIA, DAVIS
BERKELEY • DAVIS • IRVINE • LOS ANCELES • RJVF.RSIDE • SAN DIEGO • SAN FRANCISCO
CLINICAL AND TRANSLATIONAL SCIENCE
CENTER (CTSC) UC DAVIS HEALTH SYSTEM
Dear Sponsor,
UC Davis is committed to clinical research and we are pleased to collaborate with
you on this clinical trial. Over the years UC Davis has proven to be a reputable
clinical research center and we continue striving towards improving our
operational efficiency and cost effectiveness.
However, as an institution supported with public money, UC Davis has to
carefully evaluate tasks and time involved in all various aspects of a clinical trial.
We are required to recover all costs associated with industry-sponsored clinical
trials, including employee time and hospital charges. The summary of these
tasks and the time required for completion is provided for your reference in this
document. These guidelines are prepared for you in order to present a clear and
unambiguous picture of the clinical trial processes at UC Davis. The brackets
(min/max) are provided to capture the continuum of the complexity.
All current budgets for clinical trials are prepared using these standards. We
encourage you to reference these materials when negotiating the costs for your
clinical trials.
Should you have any questions, please do not hesitate to contact me:
Kate Marusina, Ph.D., MBA
Manager, Clinical Trials,
Associate Director, Regulatory Knowledge and Support
Clinical and Translational Science Center
UC Davis School of Medicine
TEL: (916)703-9177
CEL: (530)979-1522
EMAIL: kate.marusina@ucdmc.ucdavis.edu
COORD
PI
Protocol
Complete Site Feasibility Questionnaire from Sponsor
2
2
Review protocol, study logistics, feasibility assessment
2-10
1-2
Review by Scientific Review Committee (Cancer Ctr only)
2
2
Preparation and return of Sponsor/Site documents
2-5
0.5-1
Pre-Study Site Selection visit, prepare for & attend
4-6
1
Prepare, distribute, collect and copy financial disclosures
2-3
0.5-1
Obtain and copy CV's
0.5
Preparatory Research (Pre-screening charts, as needed)
2-6
0.5-1
16-30
7-10
COORD
5-8
PI
0.5-2.5
10-12
1
1
0
15-20
1-2
COORD
PI
Informed Consent / DOS form, write, review and/or revise
5-8
0
Protocol and Investigator's Brochure review
1-4
0.3
Prepare & deliver IRB documents
5-20
0
TOTAL Hrs
Budget
Coverage Analysis (Prospective Reimbursement Analysis)
Prepare the study budget
Set up accounting & billing (DaFIS / Bridge/EMR) for study
procedures
TOTAL Hrs
IRB Documents
Follow up discussion with IRB reviewers / document revision
2.5-5
1
Prepare docs for Dean & Chair signature, deliver & pick up
0.5-2
0.3
Auxiliary approvals as necessary (Radiology, Biosafety, IT)
1-2
0
Scientific Review Committee, obtain approval (Cancer Ctr)
1
2
16-40
2-3
COORD
PI
5-10
2-9
5-10
2-9
COORD
PI
1-2
0
1-2
0
COORD
PI
TOTAL Hrs
Training
Train Staff for Study/Certification
TOTAL Hrs
Pharmacy
Correspondence with Pharmacy, logistics and budget
TOTAL Hrs
Communications
Correspondence with Sponsor reps
10-20
5-15
Case Report Form Review / Source Docs Preparation
5-20
0-4
Initial Investigator Meeting, Prepare and Attend
10-16
4-24
25-55
10-40
70-150
20-65
TOTAL Hrs
Total Start-up Hours