Research Site is critical to the success of Clinical Trial
The front line of clinical trials is the sites. It is the clinical research site’s performance and compliance that will determine the ultimate fate of the investigational product in a clinical trial. Site research personnel usually include the principal investigator, co/sub-investigator, study coordinator and regulatory manager. Generally all the site personnel are trained on ICH, GCP and HIPAA guidelines to ensure regulatory compliance. However, often times compliance is compromised as the site staff are stretched thin as they support multiple clinical trials.
CRAs pivotal role in verifying clinical trial data
In such scenarios, the study monitor (CRA) plays a pivotal role in ensuring compliance and in verifying the accuracy of data collected by the site. The success of the trial will not only depend on the good monitoring skills of the CRA but also his ability to build a collegial relationship with the site. In an industry where the protocol complexity increases day by day and competition for patients is on the rise, building a productive relationship with the clinical research site becomes a key factor in the success of the trial.
With ever increasing demand from the sponsor to ‘beat the clock’, the CRA needs to be mindful of the site moral and their finite resources in the rush to get the site activated, enroll the promised subjects in appropriate timeframe, and collect accurate and clean data. Surveys indicate that sites prefer to work with sponsors who set realistic enrollment goals, maintains fair payment schedule, have competent CRAs and maintain efficient communication with the site.
Monitoring Tool that enables positive relationship
While a monitor can be trained for good monitoring skills, he needs to be armed with proper tool(s) to manage the site efficiently. CTMS (Clinical Trial Management System) is one such tool goes a long way in helping the CRAs build positive and productive relationship with the sites by helping them stay organized and up-to-date with the site’s progress.
CTMS provides a singular database to store site data. This ensures there is no gap in communication of the CRAs with the sites. Automation in investigator payment process helps maintain fair payment schedule and will boost the site moral. CTMS will help CRA keep site staff grounded and engaged, ultimately serving to meet the goals of both the CRO and the sponsor while keeping the site staff satisfied and happy.
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- 3 MYTHS ABOUT RISK-BASED MONITORING (RBM) - March 5, 2020