Information for Clinical Trial Investigators and Providers
The Research Centers at CHI Health provide the following services:
- Feasibility in recruitment of pharmaceutical and device studies for physicians
Study implementation and administration
- Coordination of contract and grant negotiations
- Preparation and submission of all regulatory documents
- Completing study-related documentation and ensuring 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
- In servicing 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.
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 CHI Health St. Elizabeth 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
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
Regulatory Affairs Specialist
- Protocol submissions to the MREC/IRB
- Protocol amendment submission
- 1572 completion and updates
- IND Safety Report submission
- Sponsor correspondence
- Curriculum vitae and license updates
Financial Reporting Specialist
- Maintain financial ledger
- Process physician payments and patient reimbursement
- Reversal of appropriate research charges from patient hospital account
Information for Clinical Trial Providers
Investigators Needed for Clinical Research
CHI Health Research Center is seeking physicians across all specialties to conduct Phase I through Phase IV clinical trials. The Center will provide the administrative support to minimize the paperwork, the nursing support to coordinate the trial, and the marketing support to help recruit patients.
CHI Health is excited to see so many members of the medical staff who have already started working in this important program. Research is vital to the mission of the hospital, and the support of our physicians and medical staff is crucial to the success of CHI Health Research Center.
For more information on CHI Health Research Center or to schedule a meeting to discuss participating as a physician investigator, please call the CHI Health Research Center Business Development office at (402) 343-5811 or firstname.lastname@example.org.
Training for Providers
CHI Health requires that all individuals conducting human subject research must complete the CITI (Collaborative IRB Training Initiative) course as part of their baseline training requirements. Additionally, the refresher course must be completed every three years. This training on the protection of human research participants is an important part of protecting the public and preserving the public trust regarding research. (Source: Institute of Medicine report by the Committee on Assessing the System for Protecting Human Research Subjects, 2001).
Annual Training/Refresher Course
Online continuing education at CITI training site
- Attending one Research Team Lunch & Learn session (CEUs are available)
- Submission of documentation of attendance and content of a conference related to human research participant protection
- Attendance at the annual Western Institutional Review Board (WIRB) training.
- Obtaining certification as Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) or similar
- Home study, self-learning modules and similar, with documentation of completion by the agency offering the training.
- Completion of online training in the subject area.