open-label BE trials maintain blindness [Study Performance]
❝ Per protocol, bioanalytical staff is blinded,others is not mentioned in protocol, but study team discuss PK parameters (without treatment assignment,such as Pre-dose concentration, abnormal PK concentration profiles, λz estimation, %AUCextrap etc.) to decide analysis set in data review meeting before database lock.
So there are no SOP w.r.t. pre-dose concentration, abnormal PK concentration, λz estimation? Generally QA goes ahead with protocol inclusion/exclusion criteria and SOP of BA.
❝ ❝ 3. Who has access to the rand. code? I do not mean who should have access.
❝ As it's an open-label BE study, CRF collect treatment sequence, so study team can access to the treatment assigment.
Does BA team also have access to CRF? Then how it is blinded?
- 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