Summit: Quality Control

Describes Quality Control’s role in helping a study adhere to protocol and regulatory guidelines.

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About this Course

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, adverse events, and protocol deviations are documented. It illustrates QC’s functions through an examination of six categories of common QC findings. The course pays close attention to the use and review of Corrective and Preventative Action (CAPA) plans.

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators (PIs), Quality Control/Quality Management Professionals, Regulatory Affairs Professionals, Research Administrators, Sponsors, Study Sites

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99.39 per person

Demo Instructions


Course Content

Summit: Quality Control

Learning Objectives:

  • Identify common quality control findings.
  • Examine considerations for real-time quality control, inclusion and exclusion criteria, eligibility checkpoints, adverse events, protocol deviations, training identification, corrective and preventative actions, and study audit preparation.

Recommended Use: Required
ID (Language): 21544 (English)


FAQs

Who should take the Summit: Quality Control course?

This course is specifically intended for those who are responsible for conducting clinical research. Intended audiences include CRAs, CRCs, CROs, faculty, principal investigators, quality control associates, regulatory associates, research administrators, sponsors, and study sites.

How long will the course take a learner to complete?

The course can be completed in 30-40 minutes.

Is the course in the series eligible for continuing medical education credits?

The course does not currently have CE/CME credits available.


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