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SKA1 ENGINEERING CHANGE PROPOSAL Phase 4: Change Review Board (CRB) Analysis Report Analysis Form ECP No: ECP- Context: SKA-TEL- ECP Title: CRB Initiation Date: CRB Chairperson: CRB Members and Comments:
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ECP PH4 CRB analysis is a process where the effectiveness and safety of a product are evaluated during the phase 4 clinical trial period.
Manufacturers or sponsors of pharmaceutical products are required to file ECP PH4 CRB analysis.
ECP PH4 CRB analysis is typically filled out by trained professionals who collect and analyze data from the phase 4 clinical trials.
The purpose of ECP PH4 CRB analysis is to monitor the ongoing safety and effectiveness of a pharmaceutical product after it has been approved for use.
ECP PH4 CRB analysis must include data on adverse reactions, patient outcomes, and any other relevant safety or efficacy information.
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