FDA, Klinik çalışma verilerinin elektronik formatta sunumu icin taslak kılavuz hazırladı.
Providing Regulatory Submissions in Electronic Format — Standardized Study Data (Kılavuz için tıklayın…)
TABLE OF CONTENTS
I. INTRODUCTION
II. BACKGROUND
III. GENERAL SUBMISSION CONSIDERATIONS
A. Planning and Providing Standardized Study Data
B. Controlled Terminologies
C. Standardization of Previously Collected Nonstandard Data
D. Data Validation
E. Exceptions to Standardized Study Data Submissions
F. Meetings with FDA
IV. ONLINE TECHNICAL RESOURCES
V. ADDITIONAL SUPPORT
APPENDIX – DATA STANDARDS AND INTEROPERABLE DATA EXCHANGE
A. Interoperability
B. Types of Data Standards
…