Table 2 Perspectives of stakeholders on the EMA and FDA descriptions
The conduct of the eIC process | |
|---|---|
EMA description | FDA description |
Positive elements: • Emphasis on EC approval in case of a remote interview in which the investigator informs the participants about the pertinent aspects of a trial • Emphasis on electronic methods that allow real-time communication for conducting the interview • Reference to national legislation | Positive elements: • Emphasis on the eIC process (i.e., having the possibility to ask questions before and during the conduct of the trial) • Flexibility because the description refers to in-person discussions as well as multiple electronic options to discuss questions with the investigator |
Negative elements: • No concrete options are provided for how the interview can be organized | Negative elements: • Reference is made to the use of electronic methods that do not necessarily allow real-time communication (e.g., electronic messaging) |