Course Description

The Periodic Monitoring Visit

Course Description:

This course provides an in-depth review of the activities related to monitoring clinical investigations after initiation. The course includes numerous practical examples based on real-life situations that monitors can encounter during ongoing monitoring activities of medical device clinical investigations.

It covers the following topics:

  • Preparing for visits whether onsite or remote
  • Planning and confirming visits
  • Case studies of handling deviations, personnel changes, or changes in resources
  • Ensuring accurate reporting of data, including safety data
  • Reporting findings during visits 
  • Following up on actions required by site personnel

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Plan an effective periodic monitoring visit whether remote or onsite
  • Use remote monitoring tools in addition to onsite visits.
  • Set up a logical agenda and ensure efficiency during the visit
  • Detect and handle non-compliance from site personnel
  • Ensure appropriate reporting from the site to ethics committees, institutional review boards, or regulatory authorities when necessary
  • Create a system for organizing monitoring visits, including logistics and time management
  • Develop a system for accurate follow-up after monitoring visits and ensure compliance of site personnel

Who Should Enroll:

Monitors, clinical research associates, and clinical trial assistants and coordinators are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • Introduction to Good Clinical Practice (ID 42)
  • The Clinical Investigation Plan (ID 44)
  • The Informed Consent Process (ID 45)
  • Adverse Event Processes (ID 59)
  • Device Accountability (ID 50)
  • Deviations and Non-Compliance Handling (ID 51)
  • Source Document Verification (ID 52)
  • The Case Report Form Process (ID 53)

Subject Matter Expert:
Danielle Giroud

120 min

Related resources:

Case studies:

Basic Account: € 429.00
Premium Account: € 322.00

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