Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unitReport as inadecuate

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, 15:127

First Online: 16 April 2014Received: 12 April 2013Accepted: 21 March 2014DOI: 10.1186-1745-6215-15-127

Cite this article as: Tudur Smith, C., Williamson, P., Jones, A. et al. Trials 2014 15: 127. doi:10.1186-1745-6215-15-127


BackgroundSome level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners.

MethodsThis paper describes the monitoring methods and procedures that are utilised by a non-commercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks.

ResultsMonitoring activities and approaches should be selected to be proportionate to the risks identified within a trial. A risk-proportionate approach to monitoring is described giving details of methods that may be considered by clinical trial practitioners during the development of a trial monitoring plan. An example risk assessment and corresponding monitoring plan for a low risk type A in the Medicines and Healthcare Products Regulatory Agency MHRA classification system pediatric trial is provided for illustration.

ConclusionWe present ideas for developing a monitoring plan for a clinical trial of an investigational medicinal product based on our experience. Alternative approaches may be relevant or preferable in other settings based on inherent risk.

KeywordsMonitoring Central monitoring On-site monitoring Risk proportionate Quality assurance AbbreviationsADRadverse drug reaction

AEadverse event

CIChief Investigator

CFcystic fibrosis

CRFCase Report Form

CTUClinical trials Unit

CTRCClinical Trials Research Centre

CTTIClinical Trials Transformation Initiative

CVCurriculum Vitae

DHDepartment of Health

DMData Manager

DMPData Management Plan

DSURDevelopment Safety Update Report

EMAEuropean Medicines Agency

FDAFood and Drug Administration

GCPGood Clinical Practice

HTAHealth Technology Assessment

ICHInternational Conference on Harmonization

IDSMCIndependent Data and Safety Monitoring Committee

IMPinvestigational medicinal product

ISinformation systems


MHRAMedicines and Healthcare Products Regulatory Agency

MRCMedical Research Council

PIPrincipal Investigator

PISCPatient Information Sheet and Consent

RECResearch Ethics Committee

RSAResearch Site Agreement

SAEserious adverse event

SDVsource data verification

SmPCsummary of product characteristics

SMTSenior Management Team

SOPsStandard Operating Procedures

SUSARsuspected unexpected serious adverse reaction

TCTrial Coordinator

TMTrial Monitor

TMFTrial Master File

TMGTrial Management Group

TMRTrial Monitoring Report

TMSTrial Management System

TORPEDO-CFTrial of Optimal TheRapy for Pseudomonas EraDicatiOn in Cystic Fibrosis

TSTrial Statistician

TSCTrial Steering Committee

UKCRCUnited Kingdom Clinical Research Collaboration.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-127 contains supplementary material, which is available to authorized users.

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Author: Catrin Tudur Smith - Paula Williamson - Ashley Jones - Alan Smyth - Simon Langton Hewer - Carrol Gamble

Source: https://link.springer.com/

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