Open AccessInvestigator preparedness for monitoring and audits
Author(s) -
Renju Ravi,
Debdipta Bose,
Nithya J Gogtay,
Urmila M Thatte
Publication year - 2018
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/picr.picr_42_18
Subject(s) - audit , protocol (science) , preparedness , process management , business , quality (philosophy) , process (computing) , computer security , computer science , accounting , medicine , political science , pathology , philosophy , alternative medicine , epistemology , law , operating system
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.