Introduction

Monitoring (based on Guideline GCP E6) :

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
Standard Operating Procedures (SOPs)
Good Clinical Practice (GCP)
the applicable regulatory requirement(s).

Monitoring of a clinical trial to assure high quality trial

conduct.
Purpose 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 the trial is in compliance with the currently approved
protocol/amendments, with GCP, and with the applicable regulatory
requirements.
Elements to monitor
1. Recruitment
2. Randomization
3. Adherence to intervention and blinding
4. Follow-up completeness
5. Important variables :
Outcome
Adverse effects
Potential co-interventions
Selection and Qualifications of Monitors
Appointed by the sponsor

Trained, and should have the scientific and/or clinical

knowledge needed to monitor the trial adequately.

Thoroughly familiar with the investigational product the

protocol, written informed consent form and information to be
provided to subjects, the sponsors SOPs, GCP, and the
applicable regulatory requirements
 Determining whether the investigator is Acting as the main line of communication
maintaining the essential documents between the sponsor and the investigator
Communicating deviations from the
protocol, SOPs, GCP, and the applicable
regulatory requirements to the investigator Verification of investigators qualifications,
Determining whether all adverse events
(AEs) are appropriately reported within the expertise and resources and availability
time periods throughout the study

Informing the investigator of any CRF entry

Verifying, for the investigational product(s)
error, omission, or illegibility

Checking the accuracy and completeness of Monitors Verifying that the investigator follows the
the CRF entries, source documents and other
trial-related records against each other
Responsibilities approved protocol and all approved
amendment(s), if any

Verifying that source documents and other Verifying that written informed consent was
trial records are accurate, complete, kept up- obtained before each subject's participation in the
to-date and maintained trial.

Ensuring that the investigator receives the current

Reporting the subject recruitment rate Investigator's Brochure, all documents, and all trial
supplies needed

Verifying that the investigator and the Ensuring that the investigator and the
Verifying that the investigator is enroling only investigator's trial staff
eligible subjects investigator's trial staff are adequately informed
about the trial
Monitoring Procedure

The monitor should follow the sponsors established

written SOPs as well as those procedures that are
specified
Monitoring Report
Monitor should submitted to sponsor
Reports include :
Date
Site
Name of the monitor
Name of the investigator or other individuals contacted.
Summary monitor reviewed, statements concerning the significant
findings/facts, deviations, conclusions, actions taken to secure compliance.
Review and follow-up of the monitoring report
Monitoring Result
Stopping for harm to make sure that the
intervention does not turn out unexpectedly to be
harmful

Stopping for benefit if benefits are obtained the the

trial should be stopped

Stopping for futility sometimes trials are stopped

early if investigators are unable to recruit or retain
enough participants
MONITORING
A CLINICAL
TRIAL
Daftar Pustaka
Hulley. Designing Clinical Research. 4 Ed. 2013
Steven Piantadosi. Clinical Trials A Methodologic Perspective Second Edition.
Wiley. 2005
ICH, E6 Guideline For Good Clinical Practice. 1996
Handbook For Good Clinical Research Practice (GCP). WHO