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Economics Limited Protocol No.: BNC210.007Version 4.0 Date: 30May2018CLINICAL STUDY PROTOCOL A Randomized, Double blind, Placebo controlled Phase II Study of BNC210 in Adults with Post-traumatic Stress
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How to fill out a phase 3 double-blind
How to fill out a phase 3 double-blind
01
Obtain informed consent from participants.
02
Randomly assign participants into treatment and control groups.
03
Ensure that neither the participants nor the researchers know who is receiving the treatment.
04
Monitor the participants for any adverse reactions or side effects.
05
Collect and analyze the data to determine the effectiveness of the treatment.
Who needs a phase 3 double-blind?
01
Pharmaceutical companies developing new drugs
02
Regulatory agencies evaluating the safety and efficacy of new treatments
03
Medical researchers conducting clinical trials
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What is a phase 3 double-blind?
A phase 3 double-blind is a clinical trial in which both the participants and the researchers are unaware of who is receiving the treatment and who is receiving a placebo.
Who is required to file a phase 3 double-blind?
The principal investigator and the sponsoring company are typically required to file a phase 3 double-blind.
How to fill out a phase 3 double-blind?
A phase 3 double-blind is filled out by collecting and recording data in a confidential manner following the protocol outlined in the study.
What is the purpose of a phase 3 double-blind?
The purpose of a phase 3 double-blind is to evaluate the efficacy and safety of a new treatment compared to a placebo or standard treatment.
What information must be reported on a phase 3 double-blind?
Information such as demographics, adverse events, treatment assignments, and study outcomes must be reported on a phase 3 double-blind.
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