Program Building & Facilitated
Training Events
:
What we are providing
This event combines a seminar-styled training with facilitated teamwork on programmatic opportunities for improvement. Before every event CRP Ally will work with programmatic leadership to identify the unique programmatic needs, goals, and any associated boundaries to define the desired outcomes. The seminar will begin with aligning the team on understanding the regulations and requirements of clinical research. Simultaneously attendees are engaged in work to assess opportunities for improvement within the program. for your team to align on the regulations and requirements associated with Clinical Research and work together to identify opportunities for improvement. 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 understandings, learn of new resources, and understand how their individual professional goals can align in support of program goals. Attendees will have a fuller understanding of the regulatory framework, requirements, and responsibilities of investigators engaged in Clinical Research; and work to develop personal and program goals that align to synthesize success for all.
This seminar 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; Regulatory Binders and Essential Documentation; Quality Assurance; Audit and Inspection Readiness; Value Stream Operations; Balancing Efficiency & Quality while Never Compromising Scientific Integrity and Protection of Human Subjects; Goal Setting; Change Management; and more...
Team
Building
Team
Alignment
Strengthen
Culture
Enhance Your
Program
This event is ideal for:
- New or growing study teams.
- Study teams looking to revise processes and procedures.
- Study teams undergoing Leadership changes.
- Study teams that merely want to connect and evaluate opportunities for improvement.
The Process is SIMPLE:
- Contact us to discuss your site's unique training and team building 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 you will receive a comprehensive report on the event, training materials covered, and process / outcomes of facilitated teamwork.
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
- Aligning Teams with Personal and Programmatic Goals
- Request for individuals' professional goal & hopes for event experience
Event Day 1: Welcome
Every event starts with:
- Welcome & education materials packet
- Introductions
- Establishing team 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
Foundational 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"
Aligning goals: stronger when headed in the same direction
Dedicated time for discussion of goals:
- Real experience in aligning goals between individuals, programs, and across departments.
- SMART goals and dependencies
- Measuring success: Key Performance Indicators and metrics.
- Strategies for buy-in through mutual beneficial outcomes.
- "Easier" change implementation within teams.
- Communication and transparency
- Sustaining success
End of event wrap-up
All events end with:
- Review of established group hopes and expectations
- Review of professional goal in-line with learnings and opportunities to align with programmatic goals.
- 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 via email 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.