As a sponsor, it’s your responsibility
to assure the regulations are met, the protocol is followed, and ethical practices are
employed at every investigative site. How do you do this? By monitoring, of course.
Monitoring means having your representative travel to the site and verify data integrity
and participant protection.
Case report forms and other documents are checked for:
Study conduct is
evaluated for:
Findings are
documented via timely monitoring reports and follow-up writings. But our monitors do more than just observe what goes on;
they educate, train, assist, and support the site in every way possible to assure
compliance with to 21 CFR Part 812, ISO 14155, ICH-GCPs,
and other good clinical practice documents.
