Operating Gonstrraints at Trial Sites
Clinical research is a complicated undertaking, with multiple partners. Complex relationships exist between the sponsor and each individual study site.
Principal Investigators (Pis) are the persons responsible for the trials but some challenges they face are:
Impacts of Sites Limitations
Low compliance to protocol, quality and timeliness, causing:
- Prolonged subject recruitment time
- Insufficient number of trial subjects
- Dragged trial period
- Expenditure increase
How to Improve
Quality of Study?
Support PIs and Investigators
Study Coordinators / Clinical Research Coordinators
How Study Coordinators can improve the Quality of Studies?
Study Coordinators (SCs) are the main liaison etween the investigators and the study subjects and between the site and the sponsor. They also handle a great deal of the study activity at clinical sites. The SC is the person in charge of managing the individual study site.
The SC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. They help assess study feasibility: handle, prepare, and track document submission; and manage the day-to-day logistics of everything.
Although the Pl is responsible for the conduct of the trial, the SC is the heart and soul of the research studyand ultimately, it is the SC who carries forward the research goals, thereby playinga significantrole in the success of the research study.
Pl and SC need to work well with a variety of departments in site to complete the study protocol successfully (see figure)
Tasks of Study Coordinator
SCs have significant roles in the following clinical study activities including: