This question relates to PAAB code 3.2.3 (information on ongoing trials)

Q1: Can you please confirm the elements that can be included in an APS - Study design, objectives, endpoints?

Q2: We are assuming that when the code states 'ongoing' it means prior to an NOC which includes a trial that is no longer recruiting but collecting data.

Q1: Yes, study design, objectives and endpoints, can be presented in a non-promotional manner per code section 3.2.3. Remember that the study must still be in the data gathering stage, with no interim analyses having been performed (including safety analysis), and it must be disclaimed accordingly.

Q2: Please see Q&A 537 and Q&A 223.


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