Clinical Research Coordinators (CRCs)

Essentials of Statistical Analysis (EOSA)

Essentials of Statistical Analysis (EOSA) courses are an efficient, low-cost way to learn about or brush up on the basics of statistical analysis. These courses...

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Good Clinical Practice (GCP)

GCP includes basic and refresher courses tailored to different training needs for clinical research teams. The basic courses provide in-depth foundational training, and the refresher...

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Clinical Research Coordinator (CRC)

CRC courses provide foundational and advanced role-based training for clinical research professionals. The courses cover information that expands beyond but is directly connected to the Human...

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Biotility: Lead Document Controller

This course introduces the principles and practices of document control, with emphasis on Good Documentation Practices (GDP), ALCOA principles, and data integrity. Learners explore document...

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Summit: Coordinating Clinical Trials

The course provides information on specific areas such as applying inclusion/exclusion criteria, taking vital signs, recording a medical history, managing subject visit flow, completing source...

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Summit: FDA Inspections

This practical course prepares clinical research sites for an FDA inspection. It provides instruction on responding to a notification of inspection, organizing staff and records,...

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ICH E6(R3): An Introduction

The course describes the ICH’s Guideline for Good Clinical Practice E6(R3). E6(R3) includes several updates from E6(R2). This video-based course examines how the changes affect...

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Summit: Quality Control

This course outlines the contours of Quality Control (QC) reviews, with particular attention devoted to QC’s evaluation of how informed consent, inclusion/exclusion criteria, eligibility checkpoints,...

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Summit: Study Documents

This course examines the role that essential documents play in a study’s adherence to Good Clinical Practice (GCP) guidelines. It outlines best practices for source...

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Biotility: Writing Controlled Documents in a CGMP Environment

This course provides learners with the skills needed to write controlled documents that minimize the risk of misinterpretation. It discusses change controls and the end-to-end...

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