Trial archive package (TAP) report

The trial archive package (TAP) report is an audit report that shows changes to studies, users, and sites.

Field Description
SponsorName Name of the sponsor company. For example, "Pharma Company ABC".
TrialName Name of the study. For example, "Trial123".
ENTITY Entity that is being reported on. Options are:
  1. Trial
  2. User
  3. Site
RECORDID Record ID number.
ACTION Executed action for the entity being reported on. Options are:
  • Add
  • Update
FIELDNAME Field name that was added or modified. For example, "SITENAME".
FIELDVALUE Value of the modified field. For example, "Gotham General".
MODIFIEDBY User name of the user who added or modified the entity. For example, "jdoe".
MODIFIEDDATE Time stamp from when the entity was last updated. For example, "02/11/2022 14:11".
REASONCHANGED Reason for change. For added entities, this field will display "Initial Entry"; for modified entities, this field will display the comment the updating user entered when they modified the field.