Monitoring of clinical trials involves overseeing the progress of a trial to ensure it is conducted properly according to the protocol and regulations. It determines the extent and nature of monitoring based on the trial's objective, design, and complexity. Monitoring verifies that human subjects are protected, reported data are accurate and verifiable, and the trial complies with requirements. It assesses risks and conducts monitoring visits to check patient eligibility, consent procedures, adverse events, product accountability, and other protocol aspects. The role of monitors is to verify case report forms against source documents, resolve data queries, discuss issues with investigators, and document visits to improve quality, promote compliance, and ensure participant safety.

1. MONITORING OF
CLINICAL TRIALS

2. INTRODUCTION
Monitoring:
 The act of overseeing the progress of a clinical trial, and of
ensuring that it is conducted, recorded, and reported in
accordance with the protocol, SOPs, GCPs, and the
applicable regulatory requirement(s)
 The determination of the extent and nature of monitoring
should be based on considerations such as the objective,
purpose, design, complexity, blinding, size and endpoints
of the trial
 In general there is a need for on-site monitoring, before,
during and after the trial

3. INTRODUCTION...
 However, central monitoring in conjunction with procedures
such as investigators’ training and meetings and extensive
written guidance can assure appropriate conduct of the trial
in accordance with GCP
 Statistically controlled sampling may be an acceptable
method for selecting the data to be verified
Monitors
 Appointed by sponsor
 No requirement for independence from study team

4. PURPOSE OF MONITORING
To verify that …
 The rights and well-being of human subjects are protected
 The reported trial data are accurate, complete and verifiable
from source documents
 The conduct of trial is in compliance with protocol, GCPs,
and applicable regulatory requirements
 Sponsor shall monitor progress of its studies

5. WHAT AND HOW TO MONITOR?
 ICH GCP – very detailed guidance
 When ICH GCP not necessary:
 No simple checklists
 Need to understand principles and purpose
 Need to think differently
 Don’t try to be a company CRA!

6. Risk Assessment:
 Systems should include a risk based programme of
routine and random monitoring
 High risk may be assessed in terms of high volume of
patients, or vulnerability of population (e.g.: Pediatric,
mental capacity) or type of medicinal product/device

7. Categories of risk
 Scale of research
 Patient population
 Intervention
 Investigator/ Research Team
 Monitoring arrangements
 Personal Data
 Protocol
 Consent
 Finance

8. MONITORING VISIT
 Eligibility of patients
 Consent & recruitment procedures
 Adverse events
 Investigational product accountability
 Other protocol requirements e.g.: Sample collection, CT
scans
 Review of site's Regulatory Documents
 Review Trial file

9. Role of Monitors
 CRF verification:
 Comparison of CRF data vs. data in source documents
(usually verify 100% of primary points)
 Data Query resolution
 Meet with PI to discuss study status, recruitment,
problems & unresolved issues
 Sign monitoring log to document visit

10. Summary
 To improve quality & promote high standards
 To identify non-compliance
 To identify research misconduct/ fraud
 Ensures safety of trial participants
 To adhere to the regulations (Research Governance
Framework, Regulatory Directives)