Regulatory Submissions and Ethics
IND, CTA, IRB and ethics committee submissions: what goes in, what delays approval and how to track it.
- Level
- Intermediate
- Length
- 8 hours
- Lessons
- 12
- Format
- Self-paced
What you will be able to do
- Assemble a complete submission package
- Manage amendments and their timelines
- Anticipate common ethics queries
- Track approvals across regions
Course content
4 sections · 12 lessons · 8h total
Requirements
- Familiarity with trial phases and study documents
- Helpful, not required: experience with a submission or ethics package
Who this is for
- Regulatory affairs and start-up staff
- Coordinators who own ethics and submission packages
- Professionals moving toward regulatory roles
Description
IND, CTA, IRB and ethics committee submissions: what goes in, what delays approval and how to track it.
Written for people already working near this topic who need sharper practice. You work through 4 sections built around the tasks the role actually asks for, each with a short worked example and a checkpoint so you can tell whether the material has landed.
This sits in Regulatory affairs: Submissions, ethics and regulatory strategy. When you are ready to show the capability rather than describe it, the next step is Regulatory affairs route in the Leadership tier.
Where it leads
Regulatory affairs route in the Leadership tier. Completing a course builds capability. It does not by itself create reviewed evidence: demonstrated work in Competency Labs by TRUVAN does.
Common questions
- Is this course assessed?
- No. Checkpoints are for your own confidence. Assessed, reviewed work happens in Competency Labs by TRUVAN casebooks.
- Does finishing this course create reviewed evidence?
- No. Courses build capability. Reviewed evidence comes from demonstrated work that is scored and reviewed in Competency Labs by TRUVAN.
- Can I buy this on its own?
- Yes. It is available as a single course, and it is also included in the TRUVAN Academy subscription alongside every other course and Labs access.
- How long do I have to complete it?
- It is self-paced with no deadline. Most people spread the material over two to three weeks alongside work.