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Monitoring plan

A monitoring plan refers to a comprehensive strategy that outlines how sites of a clinical trial are to be monitored for compliance, quality, and safety. When designing a monitoring plan, consider the following design components:

  • Monitoring Type. The monitoring plan indicates the number of monitoring visits that need to take place; these visits define the type of monitoring that needs to be conducted, outlining the trial goals. Thus, the monitoring type can be one of the following: PSSV (Pre-Study Site Visit), SIV (Site Initiation Visit), IMV (Interim Monitoring Visit), or COV (Close Out Visit).

  • Monitoring Methods. The monitoring plan defines the monitoring method that is to be used. It can be either centralized monitoring, on-site monitoring, or remote monitoring depending on the monitoring planning design and its goals.

  • Site Preparation. The monitoring plan needs to outline the criteria for selecting study sites. This also includes the process of monitoring subject enrollment and signing consent forms.

  • Monitoring Schedule. The monitoring schedule needs to be defined in order to outline the occurrence of monitoring visits and what needs to be reviewed during these visits at the mentioned study sites. The dates for the creation of monitoring visits can be set when configuring monitoring plans.

  • Adverse Event Reporting. The monitoring plan needs to outline detailed procedures for reporting adverse events and serious adverse events, including who is responsible for their reporting, what constitutes an adverse event, and the timeline for reporting.

  • Human Resources. The monitoring plan needs to outline the list of sponsors, investigators, and monitors who are required to establish communication and reporting channels in order to execute the monitoring plan properly and in a timely manner. Human resources can be managed on a separate page.

  • Risk Management. The monitoring plan needs to identify potential risks to the study, including patient safety and data integrity, and explain how these risks can be managed and mitigated in accordance with regulatory requirements.

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In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.