Research Center Sponsors - Facilities & Equipment

Facilities/environment
Our main clinic provides 2 patient exam rooms complete with 12-lead EKG machine, and sphygmomanometer. Responsibilities of the Principal Investigators and the Sub-Investigators they oversee include:

• Participant Identification and screening
• Assist with patient consenting
• Participant physical exams and counseling
• Conduct protocol specific physician procedures
• Completion of appropriate source documents and clinic charting

Each protocol is assigned a Lead Study Coordinator who is assisted by and oversees a team of professional study coordinators and research associates. Responsibilities include:

• Patient Screening and consenting
• Collection of protocol specific laboratory specimens and study procedures
• Diary counseling and verification
• Study drug assignment/instructions
• Completion of coordinator pages of sources documents
• Scheduling follow up study visits
• Shipping laboratory specimens

Equipment
On Site ECG equipment
Fully stocked certified emergency crash cart
Daily Maintained Temperature logs for the following:

• Secure, locked, climate controlled Study Drug storage
• Freezers (-20° and -70°)
• Refrigerator
• Dry Ice available

• Franciscan Health System Research Center provides safe and secure investigational supply rooms for study drug storage
• Controlled Substance Registration Certification (Schedule II, III, IIIN, IV, & V)
• Double verification at time of drug dispensing
• Limited access room
• Protected by two secured doors and locked storage area
• Certified ventilation hoods/glove boxes for preparation of IV medications
• Scientific refrigerator with alarm (monitored 24 hours a day)
• Climate controlled and documented

• Secured 33 cubic foot refrigerator
• All equipment is maintained regularly with documentation per GCP, GLP guidelines.

Sample storage
Long and short term storage of samples is available. We have -70° and -20° freezers to accommodate your specific trial needs. Our freezers are backed up by a generator to ensure the value of your information.

IT capabilities
All sites are linked through a Wide Area Network utilizing Internet Explorer. Coordinating staff members are fluent and efficient with "Remote Data Entry" and Internet based Case Report Forms.