Issue Date: February 1, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Good Clinical Practice (GCP)
Status: Draft
Survey Methodologies to Assess REMS Goals That Relate to Knowledge
This guidance provides recommendations to industry on conducting risk evaluation and 17 mitigation strategies (REMS) assessment surveys, used to evaluate respondent knowledge of 18 REMS-related information. This guidance discusses general principles and recommendations 19 related to conducting REMS assessment knowledge surveys, including study design, survey 20 instrument development, survey data collection and processing, and data analysis.
Download the Guidance Document
