ICH-GCP Clinical Research Essentials

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Projectdraft

Project case study (STAR)

Role-based GCP training for monitors, coordinators, and sites — aligned with ICH E6(R2) and sponsor audit expectations.

Jun 1, 2024

267 views

GCPClinical ResearchPharmaCompliance

Impact & Results

3.1K

Learners Reached

99%

Completion Rate

88%

Satisfaction

99%

global completion

countries unified

-42%

training-tied protocol deviations

88 CSAT

site investigator satisfaction

4 months

Project Duration

ADDIE

Methodology

Freelance Instructional Designer

Designer Role

Compliance

Step 1 — The Situation

GCP training was fragmented across vendors; auditors found inconsistent evidence of competency.

Step 2 — The Task

As a Freelance Instructional Designer, I led the end-to-end design and development of this project — from discovery and needs analysis through final delivery and implementation support.

Process timeline

ADDIE Process

Analyze

Identify needs, learners, and goals

Design

Create learning objectives and strategy

Develop

Build content and materials

Implement

Deploy training to learners

Evaluate

Measure effectiveness and iterate

Analyze

Identify needs, learners, and goals

Design

Create learning objectives and strategy

Develop

Build content and materials

Implement

Deploy training to learners

Evaluate

Measure effectiveness and iterate

Step 4 — The Solution

A modular curriculum with role pathways, localized case law callouts, and a single LMS source of truth for completions.

Step 5 — The Impact

Unified completion reporting; sponsor QA noted fewer protocol deviations tied to training gaps in pilot sites.

Tools Used

Rise 360DoceboAdobe Acrobat

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