Explore More at wakehealth.edu

Training Resources for Clinical Research

In addition to the training videos and resources listed below, the CTSI offers courses and opportunities through the Educational Offerings page.

CITI Training for New Employees

Step-by-step Instruction for Enrolling in CITI Training

You will need to go to the CITI website and create a user ID and password. The system will then ask you to affiliate with an institution.  It is very important that you choose Wake Forest School of Medicine. If you choose Wake Forest University, that is the Reynolda Campus which requires different modules and you will have to re-do our training. Once you have chosen WFSM as your affiliation, you will be asked to select your curriculum. 

There are 5 questions: 

•  Answer Biomedical Investigators for question 1.
•  If you have completed CITI before, choose Biomedical Investigators for question 2. If you have not previously completed CITI, choose that option for question 2.
•  Leave questions 3 and 4 blank and answer “No” for question 5 since they are all for optional courses.  However, if you are a team member on an NIH-funded clinical trial, you must complete the CITI course in Good Clinical Practice as required by this NIH policy

 

Once you have completed the course, the IRB will be notified and will update your eIRB account.

CITI Training Renewal

You will need to go to the CITI website and log in. If you cannot remember your user ID or password, please contact Sarah Stanfield at sstanfie@wakehealth.edu.   

Once logged in, please confirm on your main menu page under “Wake Forest School of Medicine Courses” that you are enrolled for “Biomedical Investigators”. You will either be completing the Basic Course or the Refresher Course depending on which course you previously completed. If you do not see Biomedical Investigators, please click on “Add a Course or Update Learner Groups”. 

There are 5 questions: 

•  Answer Biomedical Investigators for question 1. 
•  If you have completed CITI before, choose Biomedical Investigators for question 2. If you have not previously completed CITI, choose that option for question 2. 
•  Leave questions 3 and 4 blank and answer “No” for question 5 since they are all for optional courses. However, if you are a study team member on an NIH-funded clinical trial, you must complete the CITI course in Good Clinical Practice as required by this NIH policy

Once you have completed the course, the CITI site will email the IRB and they will update your eIRB account.

Human Research Regulatory and Oversight (Videos)

This series includes the following videos: 

  • About the Human Research Oversight Program
  • The Proper Use of a Regulatory Binder
  • Five Tips: Why Human Research Application are Tabled by the IRB

IRB & HRPP Education and Client Services

The IRB & HRPP offers the Wake Forest School of Medicine Research Community and its affiliates a "Client Services" program which includes on-site education and web-based education modules.

The Education & Training program is headed by Joseph Andrews, PhD. Please contact Dr. Andrews with questions at jandrews@wakehealth.edu

Study-Specific Regulatory and Procedural Guidance

  • Telephone or in-person consulting
  • Guidance on the development and completion of electronic submission

The Regulatory and Procedural Guidance program is headed by Jeannie Tullock. Please contact Jeannie with questions at jtullock@wakehealth.edu.

Navigating FDA Regulatory Requirements (Videos)

This three-part series provides an overview of best practices for navigating the regulatory maze of the FDA, including:

  • Help with complex regulatory requirements for new drug (IND) and device (IDE) development;
  • Learning how to optimize your communication with the FDA for IND and IDE applications; and
  • Useful tools and resources necessary for finding successful pathways from discovery to clinical implementation.