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Serious breach SOP R&D GCP SOP 17 version 2, 26.01.15R&D DepartmentNotification of serious breaches of GCP or the trial protocol at HEY HT Hull And East Yorkshire Hospitals NHS Trust 2010 All Rights

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What is serious breach sop?

Serious breach sop refers to a significant violation of standard operating procedures that may have serious consequences.

Who is required to file serious breach sop?

Any individual or organization that is subject to standard operating procedures and encounters a serious breach is required to file a serious breach sop.

How to fill out serious breach sop?

To fill out a serious breach sop, one must gather all relevant information related to the breach, outline the details of the incident, and follow any specific guidelines provided by the organization.

What is the purpose of serious breach sop?

The purpose of serious breach sop is to ensure that incidents of significant violations are properly documented, investigated, and addressed in a timely manner to prevent future occurrences.

What information must be reported on serious breach sop?

The information that must be reported on a serious breach sop includes details of the breach, date and time of occurrence, individuals involved, impact of the breach, and any corrective actions taken.

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