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 and 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 and 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

Archiving

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