Investigator Education

Who needs research education training?

The tables below reflect the CORE CHI Franciscan Health Medical Review Evaluation Committee (MREC) Education requirements.

Role Human Subjects Research HIPAA for Research Researcher COI Good Clinical Practice
Frequency Frequency: Every 3 years Frequency: Every 3 years Frequency: Every 4 years Frequency: Every 3 years
Investigators and staff conducting FDA-regulated clinical trials with human subjects. (CCR CPM, AD, Integration/Operations) Green Arrow Green Arrow Green Arrow Green Arrow
All other investigators and staff conducting research with human subjects. Green Arrow Green Arrow Green Arrow  

 

Research Education Requirement Acceptable Training Courses
(Other courses can be submitted for considered approval)
Human subjects Protection (HSP)
  • HSP course through CITI
  • HSP training through NIH
 
HIPAA for Research
  • HIPAA for Research module available through CITI
 
Researcher Conflicts of Interest (COI)
  • CHI Employees can take LEARN course: “Conflicts of Interest in Research”. LEARN can be access through Inside CHI using the My Tools menu.
  • Non-CHI Employees can access the, “Financial Conflicts of Interest” course directly through the NIH website.
  • *Stand-alone COI modules IF you have already completed the GCP training that did not include COI modules – See the table below
 
Good Clinical Practice (GCP)  

The following courses and stand-alone modules meet the MREC Research Education Requirements for Researcher COI (Only one of the options below need to be completed)

 

Green Arrow

CITI Conflicts of Interest Course containing the following modules:

  • Module 1 – Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules (ID: 15070)
  • Module 2 – Institutional Responsibilities as They Affect Investigators (ID: 15072)
  • Module 3 – Conflicts of Commitment and Conscience (ID: 15073)
  • Module 4 – Institutional Conflicts of Interest (ID: 16765)
 

Green Arrow

CITI Conflicts of Interest module:

  • Conflicts of Interest in Research Involving Human subjects (ID: 488)
 

Green Arrow

LEARN Module: “Conflicts of Interest in Research”

  • This LEARN module is available to CHI Employees with access Inside CHI . You will find a link to LEARN through the My Tools menu.
 

Green Arrow

NIH Module: “Financial Conflicts of Interest”

  • Non-CHI Employees can access the, “Financial Conflicts of Interest” course directly through the NIH website.
 

The following Stand-alone module DOES NOT contain sufficient information to meet the MREC Requirements for Researcher COI


red X

CITI Conflicts of Interest module:

  • Conflicts of Interest in Research (RCR-Basic) (ID: 16599)
 

If you are new to the CITI Program, instructions for new learners can be found here: http://www.citiprogram.org/citidocuments/welcome/newlearnerinstructions.pdf.

If you already have a CITI Program account you can affiliate with more than one organization and any coursework that is required by both organizations will be recognized by each organization. Please follow the steps below to affiliate with CHI.

  1. Access the website www.citiprogram.org
  2. Sign in using your username and password
  3. From the Main Menu on your profile click on the link “Click Here to Affiliate with Another Institution”
  4. Select the drop down menu from the Participating Institutions field
  5. Scroll down to and click on Catholic Health Initiatives
  6. Answer the member information questions required by CHI
  7. Enroll in the course(s) required by CHI

When all of the information is completed, the CHI required courses for your learner group will be displayed. Each course contains multiple modules and each module has a quiz with a few questions about the content. Each module must be completed with a passing score of 80% to receive a certificate of completion for the course.

Caveats:

  1. You can take one module at a time, log off, come back later and finish
  2. After you take the exam, CITI will give you the correct answer to any questions that were incorrect with an explanation. You are then offered a chance to retake the exam. Watch out – they will mix up the order of the questions the second time you take it, so read the questions.

You will be notified every three years for renewal.

Refresher Course GCP for Clinical Trials with Investigational Drugs and Biologics – ICH Focus Refresher:

Listed below are the available modules within the GCP for Clinical Trials with Investigational Drugs and Biologics – ICH Focus Refresher course, as well as recommendations / requirements for how they are presented. It is recommended (and required to meet TransCelerate minimum criteria) that the following modules be presented as required:

  • International Conference on Harmonisation (ICH): GCP Requirements
  • Investigator’s Responsibilities and GCP
  • Informed Consent
  • Safety Management
  • Investigational Product (Drug) Management
  • Audits, Inspection, and Monitoring of Drug Studies
  • Sponsor Responsibilities and GCP