Investigator Initiated Trials
Developing, writing, operationalizing, and conducting clinical trials is incredibly complex. To aid in investigator continuing education about some of these complex processes, we have put together the following on-demand lectures. They cover a variety of topics from the creation of a clinical trial to responsibilities associated with sponsoring a clinical trial to business principles surrounding project management of activating clinical trials.
The following training courses are coming soon for our investigators. Each course will come with a certificate of completion and you will receive CME credits.
Creating your Clinical Trial Protocol
Leila Kiefer, PhD, gives a survey of clinical protocol goals and best practices from literature, guidances, and experiential knowledge.
Two Successful Clinical Trialists Reflect on How They Got Their Start*
Claire Dees, MD, talks with Jared Weiss, MD, and Carey Anders, MD, about their early experiences in running a clinical trial, including investigator-initiated clinical trials.
Protocol Amendments vs. Administrative Letters
Kaitlin Morrison, PhD, discusses what an administrative letter is and when an administrative letter can be used to clarify a clinical protocol versus when a full amendment is required.
IIT- Protocol Amendments
Nasrin Babadi, PhD, takes attendees through LCCC’s processes for amending protocols and submitting them to FDA talking about key tips on how to best edit your protocol and applicable FDA regulations for submitting your protocol.
FDA- INDs and IDEs
5 Tips for Developing and Maintaining an IND
Kaitlin Morrison, PhD, takes attendees through a quick 5 tips that will help you and your team successfully manage an IND.
Everything that a PI Needs to Know about Holding an IND
Kaitlin Morrison, PhD, reviews all of the major responsibilities of holding an LCCC sponsored IND. She takes you through errors made in the past so you can make sure that you don’t make them on your study.
IND Boot Camp
In this talk, targeted at the CPO regulatory team, Kaitlin Morrison, PhD, talks through how INDs are maintained at LCCC and the responsibilities of study team members.
IIT FDA Annual Reports
Nasrin Babadi, PhD, takes you through how to write an IND annual report and the LCCC processes surrounding IND annual reports.
IND Safety Reporting- LCCC IITs
In this talk, Kaitlin Morrison, PhD, covers how to fill out a MedWatch report form and how/when/why to notify FDA of an SAE.
Working with Investigational Assay Results
Kaitlin Morrison, PhD takes you through when a correlative assay is considered an FDA regulated device and what types of devices require different levels of IRB and FDA approval.
Kaitlin Morrison, PhD takes you through the sponsor responsibilities outlined by Good Clinical Practices (GCP) and FDA regulations and what LCCC infrastructure and processes are used to meet those obligations.
Advanced Trainings IIT trainings
Gene Therapy- FDA and Local Considerations
In this talk, which was presented to FDA, IRBs and study teams throughout the US, Kaitlin Morrison, PhD takes you through gene therapy trials and what you need to know about them beyond your typical IIT process. This includes insights into specific protocol requirements and additional review bodies that will oversee your study.
Hot and Cold Topics for Investigators
Kaitlin Morrison, PhD takes you through the top topics investigators are asking about and the other questions that they should be asking too.
These topics include:
- I want to grant a single-subject exception. What should I consider? Is it allowed?
- What is a single patient IND vs. what is an expanded access program? What resources are there to help me?
- I have an idea for a letter of intent (LOI) or an approved concept, now what? Who is there to help me?
- What happens if my concept is for a multicenter study? When can I open my sites?
- When do I need to send an IND safety report to FDA for my study?
- What is Part 11 Compliance and why should I care about it?
- What is the electronic common technical document (eCTD) and why should I care about it?
- What is institutional conflict of interest? What could happen if we have it?
LCCC’s Single Subject Exception Policy
In this talk by Kaitlin Morrison, PhD and Carrie Lee, MD, MPH, Kaitlin takes your through LCCC’s policy on single subject exceptions, why we do not allow eligibility single subject exceptions on IITs and what the process is to ensure proper regulatory approval for other types of single subject exceptions.
Understanding when Assays become Investigational Assays*
In this talk Mike Matamoros, MS, CIP and Cassie Myers, CIP take you through IRB regulations about investigational assays, using COVID-19 assays as examples.
Clinical Trial Activation
Activation 101- Who are the Players
Kaitlin Morrison, PhD takes you through all the different players and roles involved in clinical trial activation.
Activation 201- What is the Role of the Activation PM
This talk given by Kaitlin Morrison, PhD takes you through the role of the activation project manager and how they facilitate activation of treatment clinical trials.
What is a “Critical Path” and How Can it Help Me?
Kaitlin Morrison, PhD takes you through the business principles of critical paths, PERT charts and Gantt charts and how they can be used to streamline clinical trial activation.
Project Management of CPO Trial Activation 101
This lecture takes you through business principles as defined by “Project Management: A Systems Approach to Planning, Scheduling and Controlling” by Harold Kernzer. Kaitlin Morrison, PhD will cover what is traditional vs. matrix management, what project management is, and how project managers collaborate with line managers. She will then talk about how these processes can be used to facilitate clinical trial activation.
*CMEs will not be awarded for these talks