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System Operation Procedure SUBJECTTHUNDERSTORM/STORM PROCEDURE1.0GENERAL .................................................................................................. 22.0DEFINITIONS ............................................................................................
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What is explanation of spc severe?
Explanation of spc severe is a document that provides details and justifications for any significant adverse events or deviations from the expected results in the study.
Who is required to file explanation of spc severe?
The principal investigator or the designated responsible party is required to file the explanation of spc severe.
How to fill out explanation of spc severe?
The explanation of spc severe should be filled out by providing a detailed description of the adverse event or deviation, the impact on the study, and any corrective actions taken.
What is the purpose of explanation of spc severe?
The purpose of the explanation of spc severe is to ensure transparency and accountability in reporting any significant issues that may impact the integrity of the study.
What information must be reported on explanation of spc severe?
The explanation of spc severe must include a description of the event, the underlying cause or reason, the impact on the study, any actions taken to address the issue, and any future implications.
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