pISSN 1226-6051
eISSN 2508-786X

Table. 1.

Table. 1.

Composition of the questionnaire used to ‘Survey on introduction of DSUR’ for PV specialists in Korea

Question
Section 1: Current status on Pre-Market Safety Information Management System in Pharmaceutical companies
• Does your company use a database to manage SAE data collected from pre-market clinical trials? If yes, what kind is it?
• Does your company perform a regular safety assessment (or benefit-risk assessment) for investigational product?
• If yes, please fill out the time or period of evaluation.
• Does mandatory submission of DSUR lay an added burden on your company? If yes, why do you think so?
Section 2: An Investigation of opinion on introduction of DSUR submission and management
Scope • Do you agree to apply the mandatory submission of DSUR to all medicines when introduced in Korea?
[When selecting ‘Not Agree’] If you prefer to gradually encompass more and more investigational product subject to the mandatory submission of DSUR, please arrange the items in order of priority that should be applied first. [e.g. A-B-C-D-E]
• Which of the following do you think should be exempt from the mandatory submission of DSUR? (multiple answers allowed)
Procedure • In the year of initial introduction of the DSUR submission, which phase of clinical trials do you think should be applied to DSUR submission? (multiple answers allowed)
• Which do you think is the appropriate time for last DSUR submission?
• According to DSUR guideline, pharmaceutical company should submit both PBRER and DSUR when it conducts clinical trials on licensed drugs. Please select your preferred post-marketing safety reporting method for investigational product.
• How long do you think a grace period is needed after the introduction of the mandatory submission of DSUR for investigational product?
• If you have any other opinions regarding the introduction of DSUR, feel free to weigh in with your comment.
Korean J Clin Pharm 2021;31:53-60 https://doi.org/10.24304/kjcp.2021.31.1.53
© 2021 Korean J Clin Pharm