Course Description

The Periodic Monitoring Visit

Course Description:

This course provides an in depth review of all activities related to the monitoring of a clinical investigation after initiation including:

  • How to prepare for the visit.
  • How to plan and confirm the visit.
  • How to handle deviations including several case studies.
  • How to handle personnel changes or changes in resources including case studies.
  • Ensuring accurate reporting of data including safety data.
  • How to report any findings during the visit and follow up on actions required by the site personnel.

Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Plan effectively a periodic monitoring visit, setup an accurate agenda and ensure efficiency during the visit
  • Detect and handle non-compliances from the site personnel
  • Ensure appropriate reporting from the site to Ethics Committees or Institutional Review Boards and where needed to regulatory authorities
  • Develop a system for organizingmonitoring visits including effective logistics and time management
  • Develop a system for accurate follow up after a monitoring visit and ensure compliance of the site personnel.

Who Should Enroll:

Monitors / Clinical research associates, clinical trial assistants, clinical trial coordinators.


Prerequisite Knowledge/Requirements:

Understand the basis of Good Clinical Practice (ID 42), what is a clinical investigation plan (ID 44) ,an informed consent process (ID 45) and adverse event  processes (ID 59) is needed to have a meaningful understanding of this course. This course should be taken in combination with the course on source document verification (ID 52), device accountability (ID 50), deviations and non-compliance handling (ID 51) and the case report form process (ID 53).


Subject Matter Expert:
Danielle Giroud

Duration:
120 min

Release date:
09/30/2009

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 354.00
Premium Account: € 266.00

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