ICH GCP GUIDELINE DROPS IRB REVIEW OF INVESTIGATOR REMUNERATION OPPOSED BY INDUSTRY; RESIDUAL SOLVENTS GUIDELINE, FOUR OTHERS COULD REACH STEP 2 BY MAY
Executive Summary
The latest draft of the International Conference on Harmonization good clinical practice guideline allows institutional review boards to request financial information but eliminates the requirement that IRBs routinely review such information, FDA Clinical Trial Design & Analysis Division clinical reviewer Janet Gress told at an April 16-17 Drug Information Association meeting in Rockville, Md.