Creating Protocol Deviations
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Protocol Deviation is a marking type that is added to a data field when an event or timing differs from what is selected in the protocol.  For example, a protocol deviation is added when a subject misses a visit and the visit occurs 3 days late. You require permission to edit and or inactivate protocol deviations.

 

  1. Navigate to a Study > Site > Subject > Form.

  2. Click marking to the right of the data entry field.

 

 

  1. Select Protocol Deviation from the list of Marking Types.

  1. Enter a comment in the text box or insert a Markup tag using XML (Extensible Markup Language) that will translate into either text or a link. For more information on Dynamic Marking Tags, see Using XML in Markings.

  2. Select data from additional dropdowns if available.

  3. Click Save.

 

 

 

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