AurouSpeak - The quarterly newsletter from Aurous HealthCare CRO Vol 01 Ed 02 | Page 6

AurouSpeak
RISK BASED MONITORING - OVERSIGHT OF CLINICAL INVESTIGATIONS…
The United States - Food and Drug Administration (USFDA) brought our this Guideline for Industry “Oversight of Clinical
Investigations - A Risk Bases Approach to Monitoring” in August 2013.
This guideline is to assist sponsor or CRO in developing risk based monitoring strategies and plans for investigational studies of
medical products, including human drug and biological products, medical devices and combinations thereof. The overall goal of this
guidance is to enhance human subject protection and the quality of the clinical trial data by focusing sponsor oversight on the most
important aspects of study conduct and data reporting.
Effective monitoring of clinical trials by sponsors or CRO is critical to the protection of human subjects and the conduct of high quality
studies. A risk based approach to monitoring focuses on sponsor oversight activities on preventing or mitigating important and likely
risks to data quality and to processes critical to human subject protection and trial integrity. Monitoring findings should be evaluated
to determine whether additional actions - training of Investigator and site staff, clarifications of protocol requirements) are necessary
to ensure human subject protection and data quality across sites.
The guideline gives an overview of the following monitoring methods
 OnSite Monitoring: In person evaluation carried out by sponsor/CRO at the sites in which the clinical trial is being conducted
Onsite monitoring helps identify data entry errors and missing data in source documents; assess familiarity of site staff with protocol and required procedures and assess compliance.
 Centralised Monitoring: Remote evaluation carried out by sponsor/CRO at locations other than clinical trial sites. Since this
would heavily depend upon timely updation of electronic data capture modes, US-FDA ascertains that this will keep the timelines
of the trial in a more realistic check. Every discrepancy and query resolution is monitored and tracked making it easier for cold
audits and audit trails.
 Risk Based Monitoring:
 Identify critical data and processes to be monitored. Risk ass W76