Use this template to create your Risk Based Monitoring guideline. Make sure you review this in conjunction with the Risk Based Monitoring in Practice presentation for the best possible result.

1. Monitoring Plan Template
Study Protocol:
Stage/Phase of Study:
Introduction:
Brief description of the study landscape – geography of the sites, anticipated reach of the population,
potential challenges in terms of enrollment and compliance by both study participants and sites.
Description of Monitoring Approaches:
Include in this section a description of the monitoring methods to be employed especially noting how the
critical elements/data points/end points will be collected. Note too and risks involved and how these risks
might be mitigated (at a high level). Also include the timing and frequency of the various approaches you
are planning and how changes will be made and communicated through the study team.
In this section also include what the threshold are for action or those specific trigger points that might
require a site to be monitoring on a more frequent basis.
Also include definitions for deviations and how they should be reported and recorded.
Communication Plan:
Describe how reports and monitoring results will be communicated throughout the team. Identify/Define
specific standard reports and how and when they will be generated and then communicated.
Also include an escalation process of communication should the need arise or unforeseen challenges
emerge during the course of the study.
Management of Noncompliance:
Describe the process for addressing challenges of noncompliance or the resolution of significant issues
that have not yet been resolved. Again build upon the communication escalation process to make sure
that there is an escalation process in place should it be necessary.
As part of the process, in this section you should also describe a procedure to conduct a root cause
analysis and how the issue will not resurface later in the study.
Quality Monitoring Process/Plan:
In this section describe the specific training and qualifications needed of all study team participants from
the sponsor’s perspective through to each site perspective.
Planned audits of monitoring across several levels should be defined as well as a description of the
process in case there is a need for an unplanned or for cause audit.
Also included in this section should be the plan for co-monitoring trips or oversight to ensure consistency
of monitoring and compliance to documented monitoring processes and procedures.
Amendments