For Principal Investigators

Active Involvement and Supervision Requirements (clinical trials)

The PI is ultimately responsible, even if certain activities are delegated, and is required to identify and oversee the entire research team, including sub-investigators. 

This requires a:

Thorough and Ongoing Informed Consent Process

Accurate and Complete Documentation

Meticulous Management of Finances and Billing

Informed Consent

UofL outlines several types of consent processes, you can find here.

Some best practices for informed consent include:

Allocate sufficient time for the initial discussion to ensure participants understand the study commitment, including risks, benefits, and costs.   

PI sign-off on inclusion/exclusion criteria is required and documents PI knowledge of the enrolled patient.   

Consent forms cannot state there is no cost to participate if the study includes routine visits, tests, or procedures, and investigators must avoid promising free services.    

RE-CONSENT

Re-consent is required for changes in participant responsibilities, new safety information, new alternative treatments, pediatric patients turning 18, PI changes, improper initial consent, fluctuating participant capacity, or when mandated by IRB or sponsor.   

The informed consent process is continuous, not just a signature. 

If consent issues are identified, the study team may be subject to real-time consent review, requiring scanning and emailing the complete signed consent form within 24 hours.  

Submit a question regarding informed consent. 

Complete & Accurate Documentation

Principal investigators must maintain a research file and case report for each subject, including consenting documentation, drug/device administration, diagnosis, and inclusion/exclusion criteria information.   

Proof of oversight includes signing off on lab work, tests, visit worksheets, CRFs, and exams.   

Research orders, visits, procedures, and the Z00.6 code must be documented in Cerner and Epic. (Request EMR access if needed.)  

Be cognizant of all interventions to ensure the study is conducted according to written protocols.   

Securely store research information in paper and electronic form, adhering to UofL Information Security Policies.   

Click here to view information on security policies. 

Initiate EMR Access

View information on reporting adverse events. 

Meticulous Management of Billing & Finances

To effectively manage billing, PI's need to understand the difference between clinically-indicated patient care and research-related items and services.   

Billable services at ULP or UofL Health locations are patient care costs and handled through normal revenue cycle operations.   

Items completed by providers outside of billable CPT codes can be considered research effort and compensated via grants or ULRF allocations.   

Do not hold charge slips, avoid documenting services, or be paid for services already covered by a billable CPT code.   

Report all items and services occurring in ULP or UofL Health facilities to the ULHRO billing team to ensure charges are intercepted and directed according to the approved billing plan.   

The billing plan and consent forms must be consistent; items listed as "free" in the consent cannot be billed to insurance or the patient.   

Report activity or request reporting template.