Journal of Clinical Trials
Open Access

Effective monitoring plan in clinical trial process

International Conference on Clinical Trials

July 27-29, 2015 Orlando-FL, USA

Arpit kumar Navinchandra Shah

Posters-Accepted Abstracts: J Clin Trials

Abstract :

Clinical trial monitoring is defined by the International Conference on Harmonisation of Good Clinical Practice (ICH
GCP) as ‘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) and the applicable
regulatory requirements. Main goal of clinical trial monitoring is to ensure 100% source data verification to avoid errors like
protocol violation and safety. Outcome of clinical trial depend upon the gathered data from clinical trial sites and that too again
reflect the quality documents retrieved. To minimize errors in clinical trial monitoring process various ‘hybrid methods’ have
been developed and some of them endorsed by regulatory governing body. Some of advanced adopted methods include (1)
Central Monitoring (2) On-site monitoring (3) Targeted SDV (4) Remote Monitoring (5) Risk base Monitoring or SDV. Central
monitoring process is cost effective, convenient and reduces the need of site visit every time. Central monitoring approach
allows monitoring of all clinical trial sites at a time on real time basis. Onsite monitoring (OSM) is conventional method for
clinical trial monitoring process which allows trial monitor/representative/CRA to perform SDV on trial site. OSM approach
is effective where all prospects including trial process documentation at site will be rectify; although OSM is time consuming
process. Targeted SDV comprises of fixed field approach or random field approach; where SDV of high risk data will be done.
This method will give complete SDV of high risk data. Remote monitoring includes remote access to patient electronic medical
records (eMRs) for SDV which make limited resource allocation and cost effective. Risk-based monitoring approach focuses on
the high risk data points i.e., data points which are prone to mistakes or difference in interpretation or transcription and which
have a high impact on the quality of the data and the outcome of the study. In addition to the specific study details, several
other factors are kept into account while formulating a risk-based monitoring plan including the data quality from similar
studies, experience level of site in handling such studies. At consensus, by establishing quality management process in clinical
trial monitoring, the possible errors in monitoring process should be rectified and ‘error free’ data generation will be possible.
Various operational aspects such as process monitoring, task monitoring, resource monitoring and product monitoring will be
helpful to minimise error and strengthen the vigilance over trial progress and outcome. By looking towards present scenario of
monitoring methods adopted in the field of clinical trials; it is worth for industries to adopt “hybrid approach” of clinical trial
monitoring (integrated by existing system) which is more convenient, reduce total cost and ensure 100% SDV along with data
integrity.