Before revision: Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on Good Clinical Practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the authoring of the IB in the European Union (EU), Japan, and the United States URL Guidance documents As part of its guidance on Good Clinical Practice (GCP), the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the contents of the IB in the European Union (EU), Japan, and the United States (US).
After revision: Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the authoring of the IB in the European Union (EU), Japan, and the United States URL Guidance documents As part of its guidance on Good Clinical Practice (GCP), the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the contents of the IB in the European Union (EU), Japan, and the United States (US).