Research Center Information for Investigators

The Franciscan Health System Research Center provides the following services:

Study selection  

• Recruitment of pharmaceutical and device studies for physicians

 Investigator training

Study implementation & administration

• Coordination of contract and grant negotiations
• Preparation and submission of all regulatory documents
• Completing case report forms and insuring adherence to study protocol

Clinic & patient coordination

• Recruitment and screening of potential study participants
• Implementation of the clinical study within the hospital and/or physician practice
• Inservicing appropriate staff on protocol
• Tracking participants throughout the study
• Coordination of all clinical procedures

Study protocol delegation
All protocols are conducted under the oversight of the Principal Investigator and a dedicated investigational drug pharmacist as Research Center Manager.

Principal Investigators are assisted by Sub-Investigators, whose responsibilities 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
• Principal Investigator is responsible for oversight of study conduct and medical oversight of Sub-Investigators and Franciscan Research Center staff.

Each protocol is assigned a Lead Study Coordinator who is assisted by and oversees a team of professional study coordinators. Coordinator 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 source documents
• Scheduling follow up study visits
• Shipping laboratory specimens

Three research associates (pharmacy technicians cross-trained in laboratory specimen processing and clinical research protocol) assist coordinators in the implementation of protocols and in carrying out protocol procedures, as appropriate. Their responsibilities include:

• Prepare pharmacy dispensing instructions under the oversight of a registered investigational drug pharmacist
• Medication dispensation under supervision of pharmacist
• Maintain study drug/device inventories/accountability and other supplies as needed
• Lab processing
• Lab shipping
• Assist in transfer of data from source document to case report form
• Reversal of appropriate research charges from patient hospital account

A full-time Regulatory Affairs Specialist who facilitates all regulatory and financial processing to include:

• Protocol submissions to the MREC/IRB
• Protocol Amendment submission
• 1572 completion and updates
• IND Safety Report submission
• Sponsor Correspondence
• Curriculum Vitae & License updates
• Maintain financial ledger
• Process physician payments and patient reimbursement