Investigator preparedness for monitoring and audits

• Main Authors: Renju Ravi, Debdipta Bose, Nithya J Gogtay, Urmila M Thatte
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2018-01-01
• Series: Perspectives in Clinical Research
• Subjects: Investigator's responsibilities; quality assurance; quality control; site preparedness
• Online Access: http://www.picronline.org/article.asp?issn=2229-3485;year=2018;volume=9;issue=2;spage=95;epage=98;aulast=Ravi

Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also offers potential solutions for challenges faced during the process of monitoring and audits. It is important to remember that no monitoring or audit can ever substitute for a well-designed and articulated protocol. In addition, a determined approach by the investigator and his/her team to ensure that all aspects of the protocol are adhered to in totality will go a long way in assuring quality.