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. 2021 Nov 17;56(2):220–229. doi: 10.1007/s43441-021-00350-4

Table 1.

Questions on the Survey

1. Respondent background

 Respondent’s name and contact information

 Institution, department

 Main job role (physician, clinical research coordinator, research ethics coordinator, biostatistician, project manager, monitor, or other)

 (Optional) Main research area

2. Principles of ICH

 Are any revisions needed for each principle in the current ICH-E6?

 Do you have any suggestions for adding new ICH principles?

3. Sections of ICH

 Are any revisions needed for each section in the current ICH-E6?

 Do you have any suggestions for adding new ICH sections?

4. General questions

 Do you have any expectations and concerns for the ICH-E6 revision?

 Are there any items in the current ICH-E6 considered to be disadvantageous for patients?

 How do you think patient involvement should help drug development?

 How should we solicit the opinions of patients and public on ICH-E6 revision?

 Did you experience any issues while conducting clinical trials during the COVID-19 pandemic?

 Do you have any other comments?