Off-Label Use of Marketed Drugs in Clinical Trials: Investigational New Drug (IND) Considerations
Friday, November 8, 2019
12:00 – 1:00 pm
CTRB 3256, 2004 Mowry Road
- Sheila Austin, MS, CIP, CTSI Regulatory Specialist
The FDA IND application and submission process for the use of a marketed drug in clinical research can seem overwhelming and not worth the effort. Don’t let a terrific research opportunity slip away because you are not familiar with the process.
Bring your lunch, learn about the tools the CTSI has developed to make this process as simple as possible, and find out how the CTSI Regulatory Specialist can help you!
Presented by the CTSI Regulatory Knowledge and Support Program
Clinical Research Professionals Advisory Council Seminar Series
Please join us on the following Fridays from noon – 1 p.m. in C1-11, Communicore. Alumni Auditorium for remote participants in Jacksonville.
|Aug. 30, 2019||Conflict Management by Jade Williams|
|Sept. 27, 2019||Diversity and Cultural Competence by Antonio Farias, Chief Diversity Officer and Senior Advisor to the President|
|Oct. 31, 2019||Mentoring for Clinical Research Professionals by Yulia Strekalova|
|Dec. 5, 2019||TBD|
If you are interested in Clinical Research Career opportunities please join our supportive Yammer community for ongoing information and opportunities. Yammer is a private microblogging / collaboration platform for social networking at UF allowing members to connect and communicate using an interface that loosely resembles Facebook. This platform is useful in that we can communicate via Yammer rather than a list serve or random emails. You will find will various resources posted there and we will post relevant materials and information on this site going forward and everyone can engage in ongoing discussions.
In order to join please go to Yammer.com and select “Login” in the top right. Then, enter your Gatorlink address (DO NOT use a sub-domain like shands.ufl.edu or you will be directed to another Yammer group). To get set up, you can read more about Yammer here: http://citt.ufl.edu/tools/yammer/. Once you enter your Gatorlink email address, tab and wait for the UF credentialing page to show up. DO NOT ENTER YOUR PASSWORD on the Yammer login page. After a few seconds, you will see the usual Gatorlink login page. Enter your Gatorlink credentials again and you will be directed to the ufl.edu Yammer group.
You can either search for Clinical Research Career Interest using the group name, or email Bob Kolb (firstname.lastname@example.org) to let him know you’re on Yammer, and he will search for and add you.
CTSI Certificate of Basic Coordinator Training
Experienced research coordinators are in demand both locally and nationwide. Certification can lead to many different career possibilities that can include clinical and commercial applications with greater professional growth and higher levels of pay.
The CTSI Certificate of Basic Coordinator Training provides entry-level education for those who wish to become a clinical research coordinator. Potential students include health professionals working in nursing, nutrition, respiratory therapy, occupational/ physical therapy, or similar allied health fields.
The certificate program consists of two required courses and one optional course. These courses can be taken in any order. Students set their own pace, and most are expected to complete all requirements in approximately two semesters.
For more information, visit https://www.ctsi.ufl.edu/education/research-coordinators/research-coordinator-certificate-program/.
Resources for Clinical Researchers
Online Training Opportunities
Good Clinical Practice (GCP) for Social Behavioral Research
This course is designed for principal investigators. research study coordinators, and other staff involved in social and behavioral research at UF, and is available at myTraining. There are no prerequisites, and the course will require approximately 2 hours, 15 minutes to complete. https://rod.sumtotalsystems.com/ufshands/app/management/LMS_ActDetails.aspx?UserMode=0&ActivityId=30405
CITI Program – Collaborative Institutional Training initiative
You may sign up for CITI Clinical Research Coordinator Training and a variety of other CITI courses via MyUFL.
1. Go to http://my.ufl.edu
2. Log in using your UFL credentials
3. Go to Main Menu > My Self Service > Training and Development > CITI Training
4. On the next Window select “Agree & Continue”
5. Update your contact information, if necessary
6. Click on Main Menu
7. Select “Add a course or Update Learner Groups,” then scroll down to Section 6 and select “GCP for Clinical Trials with investigational Drugs and Biologics (ICH Focus)
8. Press “Submit” at the end of the page
9. The next screen should list courses you are registered in and their completion status
10. Changing your role in your institutional profile can result in changes in recommended courses
Simulation-Based Learning Platforms for Healthcare
Online series for Clinical Research training created by Merck and Syandus Inc.
ACRP eLearning Platform
Sponsored by the Association of Clinical Research Professionals; available to members of ACRP. https://www.acrpnet.org/types/elearning/
Available courses include:
Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review
Theory to Practice: Operationalize Your Clinical Study Protocol
The Drug Development Process: Improving Trial Feasibility and Exploring Your Growth Potential
Site Quality Management Tools: SOPs, Metrics and Training
Risk-Based Monitoring: The Essentials for Investigators
Risk-Based Monitoring: The Essentials for CRCs
Risk-Based Monitoring: The Essentials for CRAs
Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety
Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets That Make Sense
Managing Billing Compliance Risks: Navigating Medicare in Clinical Trials
Key Skills for Ensuring Quality Control through Risk-Based Decision Making
Introduction to Clinical Trials
Inspection Readiness: Best Practices for Managing Clinical Trial Inspections
ICH Gap Analysis Tool
Good Clinical Practice: An Introduction to ICH GCP Guidelines
GCP Test-Out Challenge
GCP for the Experienced Investigator: Reducing Risk and Avoiding Common Inspection Findings
GCP for the Experienced CRC: Partnering with Your Investigator to Reduce Risk and Avoid Common Inspection Findings
GCP for the Experienced CRA: Improving Monitoring Efficiency and Effectiveness
Form FDA 1572: Get It Right the First Time
Ethics and Human Subject Protection
eResearch: Managing Clinical Trials in an Electronic Environment
Certification Exam Preparation – PI
Certification Exam Preparation – CRC
Certification Exam Preparation – CRA
Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA
ACRP Certification Exam Preparation
ICH Gap Analysis Tool: Interactive Content
Certification Exam Preparation: Evaluation