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 Clinical
Trials
Director of the Clinical Trials Office:
Cathy
Kalnicky, BSN, CCRP
The Clinical Trials Office
was instituted to enhance the ability of the physician staff
to carry out industry-sponsored clinical studies.
The Clinical Trials
Office function is to assist any physician in the conduct
of clinical trials including
- Initial
contact with industry sponsors
-
Protocol development
- Regulatory
document preparation and filing
-
Budget preparation
-
Investigators and staff training of the GCP guidelines
Forms
LUMC
Charge Master (partial)
Research
Study Notification Form
Standard
Operating Procedures
Standard Operating
Procedure - Industry Trials
Research
Registration and Billing Notification
Clinical
Trials Program
The
goal of the clinical trials program is to conduct clinical
trials of the highest quality standard.
The program is staffed with
dedicated registered nurses, who work with physicians, pharmacists
and hospital staff to ensure accuracy in the conduct of
clinical trials. This networking also makes it possible
to gain referrals for studies.
The program was initiated to:
- Increase the number and
quality of clinical trials ongoing
- Assist departments that
otherwise could not carry on clinical research
- Increase the capabilities
of departments already staffed with research personnel
to do additional trials.
The
staff of the clinical trials program is available at a standard
hourly fee to assist investigators in all aspects of the
conduct of a trial from IRB submission through end of study
audits. The clinical trials program is currently involved
in 30 active clinical trials and has conducted over 60 trials
since its inception.
Monitor Visits
In order for monitors to view EPIC medical records, they
need to have special access granted by LUMC IT.
EPIC
access for non-Loyola study monitors - SOP
Training manual for study
monitors
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