Good Clinical Practice. A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International firstname.lastname@example.org 714-799-1617 x 25. GCP What It Is.
A Review for OCRA US RAC Study GroupSeptember 2005Ginger Clasby, MS Promedica Internationalgclasby@promedica-intl.com 714-799-1617 x 25
To safeguard study subjects’ rights & welfare by:
A compilation of clinical & non-clinical data on the product that is relevant to the product’s study in humans
Necessary for Investigator & IRB/EC review to assess the risks/benefits associated with study
Product formulation summary
Introduction/background info regarding product & investigational plan