ยฉ 2025 grapl ltd.
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
Course Summary
The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights, safety and wellbeing of participants are protected, the trial data are accurate, complete and verified from source records, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements.
In this course we describe the sponsorโs responsibilities for monitoring, focusing particularly on how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.
The course is up to date with the third revision of ICH GCP.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s)โfor a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
โข Describe how to prepare for and carry out monitoring visits to investigational sites.
โข Describe how to review case report forms (CRFs) and verify consistency of data with source records.
โข Describe how to close out a trial at a site.
โข Discuss the concept and implications of risk-based monitoring.
โข Identify warning signs that raise suspicion of scientific misconduct or fraud.
Who will benefit from this course
The course is intended for those involved in clinical research and development, in particular the monitoring of clinical trials, and those who require an understanding of what this entails. It and its companion course CT06 provide a comprehensive introduction to monitoring for new CRAs, or additional training and professional development for those already working in the field. It will also be of value to clinical research coordinators, clinical investigators and other healthcare professionals involved in clinical studies.
Module Outline
โข Course overview
โ Sets out the courseโs scope, objectives and notes on terminology.
โข Site monitoring visits
โ Despite the increasing use of remote and centralised monitoring methods, many still regard regular visiting of investigational sites by a CRA to be the front-line of clinical trial monitoring. In this session, we discuss monitoring tasks, the frequency and duration of visits, preparation for a visit, the kinds of deficiencies that may be found at the site, interaction with study staff, assessment of protocol compliance in a variety of areas, investigational product and subject recruitment issues, review of findings, and report and follow up.
โข Data checking
โ In the modern era of electronic data acquisition tools, risk-based and centralised monitoring, investigational site monitoring may be performed on-site and/or remotely, depending on circumstances. However, on-site data checking still has a role to play in providing ‘gold standard’ assurance of the reliability of the investigator’s data. In this session, we describe how to carry out CRF review and source data verification (SDV). We discuss the extent of SDV required, outline differences between paper and electronic CRFs, identify aspects of trial conduct for which CRFs and source records should be checked, discuss on-site corrections and resolution of discrepancies, and outline data retrieval and data query procedures.
โข Close-out visit
โ Almost all clinical trials require an on-site visit to close the study at a site, irrespective of whether routine monitoring visits have been made. In addition to completing tasks typically carried out at a routine visit, the CRA will be required to perform some actions specific to the end of the trial, such as retrieving or authorising the destruction of unused supplies, retrieving some essential records, and reminding the investigator of continuing responsibilities. In this session we describe the close-out of a trial at an investigational site.
โข Risk-based monitoring
โ Implications of a risk-based approach to monitoring include increased emphasis on remote and centralised monitoring rather than site visits, and a move away from 100% SDV toward risk-based and statistically directed sampling of data. ICH GCP encourages the use of risk-based monitoring. In this session we provide a brief introduction to the principles of this approach.
โข Fraud and scientific misconduct
โ The great majority of healthcare professionals undertaking clinical research act with honesty and integrity. However, cases of scientific misconduct and downright fraud do occur. Besides damaging the reputations of those who commit them, such actions have potentially serious consequences for the research and might even affect public health. In this session we distinguish error, misconduct and fraud, discuss the CRAโs role in detecting them, and describe their consequences.
โข Assessment
โ Multiple-choice mastery assessment.
Roles
Compliance, Research, Manager, Other
CPD Points
2
Region
Level
Intermediate
Course Study Time
Approx 2 hours
USA, Europe