Monitoring

The ACCORD Monitoring team provides Sponsor oversight for clinical research, ensuring participant safety, data integrity, and regulatory compliance. Using a risk-based approach, monitoring strategies are tailored to each study to support research teams from set-up to close-out.

The ACCORD Monitoring team conducts and documents monitoring activities on behalf of the study Sponsor. Monitoring is required for all studies that undergo the ACCORD combined risk assessment process and are selected for oversight. 

In some cases, studies not subject to risk assessment may still require monitoring. The Research Governance team will inform researchers if this applies.

Contact the Monitoring team
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Purpose of monitoring

As defined by ICH Good Clinical Practice, monitoring ensures that:

  • The rights and well-being of trial participants are protected
  • Reported trial data are accurate, complete, and verifiable from source documents
  • The trial is conducted in compliance with the approved protocol, GCP, and all applicable regulatory requirements

Risk-based approach

Each study is assessed to determine an appropriate level of monitoring. The combined risk assessment considers:

  • The nature of the investigational medicinal product (IMP) or intervention
  • Study phase
  • Participant population
  • Protocol and data complexity

High-risk studies are monitored more frequently than lower-risk studies. The strategy for each study is documented in a Monitoring Plan and Source Data Verification (SDV) Plan.

Support across the study lifecycle

The Monitoring team provide guidance and oversight from study set-up through to close-out, using remote, central, and on-site monitoring as required.

Types of monitoring visits

Types of monitoring visits
Type of Visit Purpose
Location Initiation Visit (LIV) Prepares and sets up a location to conduct the study. Provides protocol and Sponsor SOP training to location staff.
Routine Monitoring Visit Provides ongoing oversight and support to the site team. Frequency is set out in the Monitoring Plan.
Close-Out Visit (COV) Ensures all trial documentation is complete before archiving.
Triggered Visit Conducted when significant issues arise, at the discretion of the Sponsor (often after discussion with the Study Team). Identifies the extent of issues and ensures corrective and preventative actions are implemented.

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