Why Strategic Planning Matters and Why Most Plans Fail
Good Clinical Practice training is often treated as a box to check, a slide deck, a quiz, a certificate nobody looks at again until the next audit. TriStar Clinical Research Consulting, LLC built this training differently. Every session is led with the operational reality of a working research site in mind: what an FDA inspector actually asks for, what a monitor flags during a visit, and where new coordinators tend to make their first mistakes.
Two tracks are available. The Initial track is a full-day (or split into multiple sessions) foundation for coordinators, sub-investigators, and new site staff who need ICH-GCP E6(R2), informed consent, source documentation, and regulatory binder fundamentals from the ground up. The Refresher track is a condensed half-day session (or split into multiple sessions) for staff who already hold GCP training and need to renew it on their site's compliance cycle, with updates on current FDA guidance and common audit findings folded in.
Both tracks are delivered live in either virtual or on-site for teams, not a pre-recorded module. CEU accreditation is currently pending; sites can use completion certificates for internal compliance documentation in the meantime, with CEU credit added automatically once accreditation is finalized.
What's Included
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Initial Track (Full GCP Certification)
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ICH-GCP E6(R2) principles and application to daily site operations
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Informed consent process, documentation, and common deficiencies
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Source document standards and ALCOA-C principles
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Regulatory binder / eTMF essentials
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Adverse event identification and reporting basics
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Sponsor, CRO, and monitor relationship fundamentals
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Completion certificate (CEU pending)
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Refresher Track (Renewal / Update)
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Condensed ICH-GCP review
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Current FDA guidance and inspection trend updates
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Review of recent common audit findings across site types
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Informed consent and documentation refresher
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Completion certificate (CEU pending)
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Included With Both Tracks
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Live instruction (virtual or on-site)
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Digital training materials and reference handouts
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Group scheduling flexibility for site teams
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Optional bundling with TriStar Clinical Research Consulting, LLC's other clinical training offerings (phlebotomy, EKG, CPR/BLS, etc.) for new-hire onboarding packages
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How It Works
Step 1 — Discovery Conversation and Session Booking
Choose Initial or Refresher, select individual registration or request a group date for your team.
Step 2 — Pre-Session Prep
Registrants receive materials and any pre-work 3–5 business days ahead of the session.
Step 3 — Live Training
Full-day (Initial) or half-day (Refresher) session delivered virtually or on-site.
Step 4 — Training Complete
articipants receive a completion certificate
Frequently Asked Questions
FAQ1 Is this training accredited for CEU credit?
CEU accreditation is currently in progress. Completion certificates are issued at every session and can be used for internal site compliance documentation now.
FAQ2: What's the difference between the Initial and Refresher tracks?
Initial is a full GCP foundation for coordinators, sub-investigators, and new site staff with no prior certification. Refresher is a condensed renewal session for staff who already hold GCP certification and need to update it on their site's compliance cycle.
FAQ3: Can this be delivered on-site for our whole team?
Yes. Both tracks are available on-site for groups of 10 or more, in addition to live virtual sessions. Request a custom quote to schedule a team date.
FAQ4: Do you offer this bundled with other trainings?
Yes. GCP training can be packaged with TriStar Clinical Research Consulting, LLC's clinical skills trainings for new-hire onboarding. Request a custom quote for bundled pricing.
FAQ5: How long is each session?
Initial is a full day (or split across mutiple sessions by request). Refresher is a half-day session.
