Policies
All Principal Investigators who wish to work with the SoNLCEP are required to abide by the rules of University of Minnesota Institutional Review Board (IRB), and have up to date CITI Training. All forms and training must be completed prior to testing subjects. See procedures section below. A Study Coordinator (or equivalent) must escort research subjects in the SoNLCEP at all times.
Billing
The SoNLCEP invoices the Principal Investigator for SoNLCEP services on a monthly basis
Each new study that utilize the lab will need to have a unique invoice template created for monthly billing. To set up a new study the SoNLCEP staff needs the following information.
Name and contact information of the study PI
Name of study
Type of test(s) to be performed in the lab (e.g. stress test with ECG only, stress test with VO2 and CO, ABI, etc.) and provide a detailed justification for the performance of the study tests.
Chartstring for billing
Step 1
Schedule a research planning and consult meeting with SoNLCEP director and staff
Step 2
The SoNLCEP reviews and approves exercise research protocol
Step 3
If needed, Principal Investigator and/or relevant study staff completes the appropriate training listed below:
AHA CPR and AED for the Healthcare Provider
CITI training
Step 4
Provide appropriate forms: certificates of completed training, study protocol, informed consent, source documents for data collection, IRB approval, and any amendment approvals.
Step 5
Schedule the SoNLCEP Laboratory for training/onboarding meeting which includes
Safety training / emergency procedures
Mock trial of tests to be performed by SoNLCEP staff
Step 6
Ready to start?
Email the following to lab RAs
Informed Consent
Eligibility sheet or Exercise readiness forms (if cardiopulmonary exercise testing is being performed)
Schedule available time block in google calendar and schedule MD/cardiologist (if needed) for the test
Distribute Pretest and exercise test instructions to participant (provided by SoNLCEP)
Meet your participant at the SoNLCEP for appointment