Investigator Site Professional
Training Events
What we are providing
This is a seminar-styled training opportunity for your employees to enhance their knowledge in Clinical Research regulations and requirements. Our approach is simple: using the foundation of laws and regulations apply real-world experience and scenarios to engage in discussions of best practices. Individuals of all experience levels are guaranteed to gain new tools, learn of new resources, and obtain individualized information to aid their professional development. Attendees will have a fuller understanding of the regulatory framework, requirements, and responsibilities of investigators engaged in Clinical Research.
This training covers: Regulatory Framework & Background within the United States; The FDA's Drug and Device Approval Process; Laws, Regulations, Good Clinical Practice, and Other Guidance; The Business of Clinical Research (Usual Contracts, Budgets, Finance); SOPs and MOPs; The Lifecycle of a Clinical Trial; Regulatory Binders and Essential Documentation; Quality Assurance; Audit and Inspection Readiness; and more...
Improve
Engagement
Enhance
Expertise
Create
Community
Invest In
Your Organization
The training event is ideal for:
- Anyone wanting to learn more about Clinical Research Operations & Regulations!
- Clinical Research Coordinators
- Clinical Research Nurses
- Regulatory Coordinators
- Research Assistants
- Clinical Research Associates
- Clinical Research Supervisors and Managers
The Process is SIMPLE:
- Contact us to discuss your site's unique training needs.
- We'll prepare a customized training event agenda highlighting your special needs for your review.
- Schedule your event (NOTE: deposit to hold dates with minimum event attendance required).
- Three weeks prior to event provide CRP Ally with the event's attendee list & contact information.
- Enjoy the Event!
- 1-month following the event attendees will receive their post-event materials AND you will receive a comprehensive report on the event.
What attendees can expect.
Two weeks before event
Attendees receive the pre-event materials via email including:
- Welcome letter
- What to expect with details (e.g., time & location)
- Brief skills assessment
- Individuals' professional goal & hopes for event experience.
Event Day 1: Welcome
Every event starts with:
- Welcome & event materials packet review
- Group introductions
- Establishing group expectations, hopes, concerns, and norms to be used throughout the event
- Creation of event "Parking Lot Follow-Up" where we'll track tangential, but important questions throughout the event
Event material discourse
Material is presented and discussed leveraging:
- Real-world examples and anecdotes
- References to source laws, regulations, and guidance materials
- Attendees' current experiences, challenges & opportunities
- Any important, tangential questions that cannot be answered immediately will be logged in the event's "Parking Lot Follow-Up"
End of event wrap-up
All events end with:
- Review of established group hopes and expectations
- Review of event's "Parking Lot Follow-up" for comprehensiveness and accuracy
- Quick event experience survey
1-Month post event follow-up
Attendees receive post event materials including:
- Event report-out containing event's expectations, hopes, concerns, norms, references, resources, and responses to "Parking Lot Follow-up"
- CRP Companion Individualized Professional Development Report with personalized feedback and opportunities for continued professional development.
Our Guarantee
If our materials change after your event, YOU get the update free!
If we make changes to the training packet that attendees receive after your event, then we will send every attendee a free e-copy of the updated version. You don't need to do anything. We'll send the update automatically to registered event attendees. This guarantee is good for up to 1-year after the day of your event.