open-label BE trials maintain blindness [Study Performance]
reply as follows：
❝ 1. Who do you want to keep blind and why? Monitor, PI, bioanalytical staff, QA, sponsor, PK staff, statistics staff, pharmacy staff, clinical staff etc?
❝ 2. Are the people who create the rand. code also the people who do NCA? is it the same people who do stats?
❝ 3. Who has access to the rand. code? I do not mean who should have access.
❝ 4. Do some of the staff with access to the rand. code also undertake other functions by any chance?
Edit: Standard quotes restored; see also this post #8. [Helmut]
- open-label BE trials maintain blindness kimhuang 2023-10-14 09:19 [Study Performance]
- Blinded NCA Helmut 2023-10-14 10:40
- open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39