CRA Beginners On-line Course

CRA Beginners On-line Course

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£1,500

Date and time

Location

Online event

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CRA Beginners On-line Course

About this event

A CPD accredited intensive course which provides those starting or looking to improve their skills as a CRA with a comprehensive and valuable insight into the entry-level role of a Clinical Research Associate (CRA).

A clinical Research Associate (CRA) primarily manages the managerial aspects of a number of clinical trials, at every stage of the process.

This is fundamentally a “practical” and “hands on” workshop that focuses on current practice to ensure the CRA delegate develops practical experience of the role. Participants will learn about the role and responsibilities of the clinical research associate in the context of the regulations and rules that govern clinical trials.

TOPICS

ICH- GCP

The primary duties of a CRA

  • The specific responsibilities in accordance with ICH-GCP, SOP and regulations:
  • Before the clinical phase of the trial commences
  • During the clinical conduct of the trial
  • After completion or termination of the trial
  • Essential documents- Preparation, collation and QC
  • Ethics and regulatory submissions and approvals of the clinical trial application
  • Study Start up activities- site identification and selection, QC for IP release
  • Site Activation- SIV, ISF review and Drug supply review
  • Monitoring and Site Management
  • Study site close out activities

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