Objective

The investigator oversight activities are an important factor for the pharmaceutical industry and Clinical Research Organizations (CROs) quality assurance process. The purpose of this study is to describe the internal quality control practices implemented by the investigator to conduct clinical trials. It also outlines the role of the pharmacist as part of the clinical research team. An electronic survey was elaborated considering the Good Clinical Practice guidelines and local regulations discussed the content with investigators with experience in clinical trials and validated with 14 people involved in monitoring clinical trials. Finally, the local ethics committee from the faculty of human medicine of the Universidad Nacional Mayor de San Marcos approved the survey. 

The survey was distributed to investigators registered in the National Institute of Health database that conducted clinical trials in the period between January 2011 and August 2013.  Seventy investigators responded to the surveys from a total of 134 reached.

Data from the surveys indicate that investigational centres have implemented standard operative procedures (SOPs) or quality control activities in their clinical trials processes. Among the most common methods for clinical trials oversight in investigational centres, 86,1 % of them have SOPs. Furthermore, the investigators have routine meetings with staff to review trial progress. Besides, it was observed that the pharmacist acts as part of the research team assuming the responsibilities of the study coordinator, dispense, and storage of the investigational product.