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Data, Monitoring, and Analysis Plans

Data Collection and Management

What type of database do you need to collect your data? Evaluate the scope of data to be collected as that will drive the decision. For example, interventional studies are better suited to electronic data capture (EDC) platforms like Inform while observational studies may utilize an EDC platform like REDCap. REDCap is also suitable for web-based surveys.

It’s always a good idea to create data collection worksheets for each study visit to ensure all required data elements are collected. Here are a couple of examples of data collection worksheets that are generally included in all clinical research studies: physical exam and demographics.

Monitoring and Statistical Analysis Plans (For Multi-Centre Studies)

For Health Canada regulated clinical trials, you are required to provide oversight on the study to ensure it is conducted in accordance with the protocol, SOPs, GCP, and local requirements. Generally, this is completed by either onsite monitoring of study sites or remote monitoring through the data collected. The purpose of monitoring is to ensure the rights and wellbeing of participants are maintained, and that the data collected are accurate, complete, and verifiable from source documents (GCP 5.18.1). The extent and nature of monitoring will depend on the study. Advancing Health provides a monitoring plan template; contact Erin Cherban or Leslie Love to access the templates.

A statistical analysis plan (SAP) is created to define the details of the planned statistical analysis for your research study. It should be created before the research starts. It usually includes sample tables and listings of data, the manner in which the datasets will be analyzed, and methods for protocol deviations, unblinding, and how to deal with missing data. The SAP needs to be created by a statistician with experience in clinical trials.

Risk Management Plan

The 2016 ICH E6 (R2) Addendum to Good Clinical Practice guideline requires clinical trial sponsors to incorporate a risk management plan as part of clinical trial activities. Risk Management allows the study team to identify areas where issues may occur in a clinical study, and incorporate strategies to prevent issues from impacting the study’s successful completion. For further information see our Risk Management 101 overview.