Background: Every phase of a clinical trial should be designed in compliance with good
clinical practices by following all relevant regulatory guidelines. Patient safety, data integrity and ethics
are an integral part of a successful clinical trial which must be considered. Therefore, risk monitoring
is an essential tool to identify the risks associated with conduct of any trial. This article is a result
of extensive research conducted by a reputed pharmaceutical company to identify the potential stages
of risks associated with the conduct phase of trial that could impact the overall quality and safety of a
Methods: The skillful and experienced team members of a reputed pharmaceutical company involved
in conducting clinical trials underwent brainstorming sessions to assess and categorize the risks associated
with each stage of conduct phase of a clinical trial. They also developed a mitigation plan based
on their experiences, best practices and applicable guidance documents.
Results: During conduct phase, risks are associated with preparation of site master and trial master
file, courier of study supply to site(s) including investigational product prior to site initiation visit, patient
recruitment, telephonic monitoring, adverse or serious adverse event monitoring, site monitoring
visit(s), collected case report form pages forward to data management vendor, data query clarification
and site close-out visit.
Conclusion: A close working relationship with all the persons associated with the clinical trial, timely
monitoring and prospective mitigation planning is required for the conduct of a high quality trial.