Monitoring is the act of overseeing a clinical trial or study, to ensure that it is conducted, recorded and reported in compliance to the applicable regulations, Good Clinical Practice (GCP) guidelines, protocol and the Standard Operating Procedures (SOP). It is mandatory that an appropriate level of monitoring is carried out, to ensure the safety of trial participants, and to safeguard data quality. Monitoring activities identify deficiencies in trial conduct that might require corrective or preventive actions (CAPA).

The monitoring plan is the document that details the monitoring policies and procedures, and the proposed frequency of on-site monitoring visits across the trial sites, for a particular trial. The following details should be included in the monitoring plan:

• Monitoring strategy and its rationale
• Responsibility matrix or a breakdown of who is responsible for the monitoring activities
• Procedures, which includes site feasibility and initiation, schedule for on-site monitoring visits and site close-out.
• Procedures for protocol deviation, noncompliance, Adverse Event (AE) and Serious Adverse Event (SAE) reporting.
• Activities or operational processes that will be monitored, and how.

The monitoring plan should align with the risk management strategies developed for the trial with the extent and type of monitoring determined by the objective, design, study population, complexity of the trial.

It is the responsibility of the Sponsor to appoint adequately trained professionals to conduct these monitoring activities. To ensure compliance and quality, the sponsor may contract an external agency to monitor the conduct of a trial.

References

• Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
• ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9^th November 2016, available online (last accessed on 26.02.2019).