The Periodic Monitoring Visit

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The Periodic Monitoring Visit

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

ID: 56

120 minutes

2 modules

€ 429.00
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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

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)
General Requirements for WMDO Courses

  • Course Access Duration: Each course is available for 60 days from the date of assignment.

  • Quiz Completion: Users are allowed 2 attempts to complete each quiz, with a minimum passing score of 75%.