Potential Audit Trail Descriptions

The following tables include potential audit descriptions for objects that may appear in the Audit Trail Export job output.

Subject

Potential Audit Trail Message Description
Subject: [Subject Name] created Audit message for creating a subject record.
"[Subject Date Field]" set to "[Date]" Audit message for creating the "[Subject Date field]" in a subject record. Possible “[Subject Date Field]” strings include:
  • End of Study Date
  • End of Treatment Date
  • Enrolled Date
  • Initial Consent Date
  • Lost to Follow Up Date
  • Randomized Date
  • Screen Failed Date
  • Screened Date
  • Started Follow Up Date
  • Started Treatment Date
  • Withdrawn Date
"Subject Status" set to "[Status]" Audit message for creating the Subject Status field in a subject record.
"Latest Substudy" set to "[Latest Substudy]" Audit message for creating the Latest Substudy field in a subject record.
"Latest Cohort" set to "[Cohort]" Audit message for creating the Latest Cohort field in a subject record.
"Latest Arm" set to "[Arm]" Audit message for creating the Latest Arm field in a subject record.
"IXRS ID" set to "[IXRS ID]" Audit message for creating the IXRS ID field in a subject record.
"[Subject Date Field]" changed from "[Date]" to "[Date]" Audit message for editing the "[Subject Date Field]" in a subject record. Possible “[Subject Date Field]” strings include:
  • End of Study Date
  • End of Treatment Date
  • Enrolled Date
  • Initial Consent Date
  • Lost to Follow Up Date
  • Randomized Date
  • Screen Failed Date
  • Screened Date
  • Started Follow Up Date
  • Started Treatment Date
  • Withdrawn Date
"Subject Status" changed from "[Status]" to "[Status]" Audit message for editing the Subject Status field in a subject record.
"Latest Substudy" changed from "[Substudy]" to "[Substudy]" Audit message for editing the Latest Substudy field in a subject record.
"Latest Cohort" changed from "[Cohort]" to "[Cohort]" Audit message for editing the Latest Cohort field in a subject record.
"Latest Arm" changed from "[Arm]" to "[Arm]" Audit message for editing the Latest Arm field in a subject record.
"IXRS ID" changed from "[IXRS ID]" to "[IXRS ID]" Audit message for editing the IXRS ID field in a subject record.
"Name" changed from "[Subject ID]" to "[Subject ID]" Audit message for editing the Name field in a subject record.
"Change Reason" changed from "[Change Reason]" to "[Change Reason]" Audit message for editing a Change Reason field in a subject record.
Subject: "[Subject ID]" deleted Reason for change: "[Change Reason]". Audit message for deleting a subject record.
"[Kit/Device Number]" ID added Audit trail message that the Kit/Device [Number] ID was added
"Randomization Status" changed from "[Randomization Status]" to "[Randomization Status]" Audit trail message to indicate that the Randomization Status changed from previous state [0] to new state [1]
"[Kit/Device Number]" ID edited Audit trail message that the Kit/Device [Number] ID was edited
Emergency unmasking performed Audit trail message to indicate that the Emergency unmasking was performed
Randomization was invalidated Audit trail message to indicate that the Randomization was invalidated
"[Kit/Device Number]" redispensed Audit trail message to indicate that the Kit/Device was redispensed
Treatment revealed Audit trail message to indicate that the Treatment was revealed

Casebook

Potential Audit Trail Message Description
Casebook: [Screening ID #] created Audit message for creating a casebook record.
Casebook: [Screening ID #] deleted Audit message for deleting a casebook record.
"Casebook Definition" changed from "[text]" to "[text]" Audit message for changing the Casebook Definition of a Casebook.
Casebook frozen Audit message stating that the Casebook object was frozen
Casebook locked Audit message stating that the Casebook object was locked
Casebook unfrozen Audit message stating that the Casebook object was unfrozen
Casebook unlocked Audit message stating that the Casebook object was unlocked

Event Group

Potential Audit Trail Message Description
Event Group: [Event group name] created Audit message for creating an event group record.
Event Group: [Event group name] deleted Audit message for deleting an event group record.

Event

Potential Audit Trail Message Description
Event: [Event name] created Audit message for creating an event record.
Event: [Event name] deleted Audit message for deleting an event record.
"Event Date" set to "[Date]" Audit message for creating an Event Date field in an event record.
"[Date]" was removed from the "Event Date" field Audit message for removing an Event Date field in an event record.
"Overdue Date" set to "[Date]" Audit message for creating an Overdue Date field in an event record.
"Planned Date" set to "[Date]" Audit message for creating a Planned Date field in an event record.
"User Review Modified By" set to "[User]" Audit message for creating a User Review Modified By field in an event record.
"Change Reason" set to "[Change Reason]" Audit message for creating a Change Reason field in an event record.
"Event Date" changed from "[Date]" to "[Date]" Audit message for editing an Event Date field in an event record.
"Overdue Date" changed from "[Date]" to "[Date]" Audit message for editing an Overdue Date field in an event record.
"Planned Date" changed from "[Date]" to "[Date]" Audit message for editing a Planned Date field in an event record.
"User Review Modified By" changed from "[User]" to "[User]" Audit message for editing a User Review Modified By field in an event record.
"Change Reason" changed from "[Change Reason]" to "[Change Reason]" Audit message for editing a Change Reason field in an event record.
Query Opened: [Query message] Audit message stating that an event query was opened. [Query message] is the message the user entered.
Query Answered: [Query message] Audit message stating that an event query was answered. [Query message] is the message the user entered.
Query Changed: [Query message] Audit message stating that an event query was changed. [Query message] is the message the user entered.
Query Changed Audit message stating that an event query was changed when there is no known message.
Query Closed: [Query message] Audit message stating that an event query was closed. [Query message] is the message the user entered.
Query Closed Audit message stating that an event query was closed with no message appended.
Query Reopened: [Query message] Audit message stating that an event query was reopened. [Query message] is the message the user entered.
Event Date SDV Mode set to "[Review Mode]" Audit message stating that the event date review SDV/DMR requirement mode was set to [Review Mode]. Possible “[Review Mode]” strings include:
  • No Review
  • Optional
  • Required
Event Date DMR Mode set to "[Review Mode]" Audit message stating that the event date review SDV/DMR requirement mode was set to [Review Mode]. Possible “[Review Mode]” strings include:
  • No Review
  • Optional
  • Required
Event Date SDV set to "True" Audit message stating that the event date SDV review was set to True.
Event Date DMR set to "True" Audit message stating that the event date DMR review was set to True.
Event Date SDV set to "False" Audit message stating that the event date SDV review was set to False.
Event Date DMR set to "False" Audit message stating that the event date DMR review was set to False.
Event Date SDV set to "True" with additive reason: "[Change Reason]" Audit message stating that the event date SDV review was set to true with the selected additive reason [Change Reason].
Event Date DMR set to "True" with additive reason: "[Change Reason]" Audit message stating that the event date DMR review was set to true with the selected additive reason [Change Reason].
Event date signed. Signature Meaning: "[Signature Meaning]" Audit message stating that the event date was signed and specifies the legal signature meaning [Signature Meaning], configured by study builder.
Event date signed. Audit message stating that the event date was signed but the legal signature meaning is unknown.
Event Date signature broken Audit message stating that the event date value's signature was broken by a data change.
Event Date unsigned Audit message stating that the event date has been unsigned.
Event Date frozen Audit message stating that the event date value was frozen.
Event Date locked Audit message stating that the event date value was locked.
Event Date unfrozen Audit message stating that the event date value was unfrozen.
Event Date unlocked Audit message stating that the event date value was unlocked.
Event reset. Reason for reset: "[Change Reason]" Audit message stating that the event was reset and mentions the user-provided change reason [Change Reason] for the reset.
Event frozen Audit message stating that the Event was frozen.
Event frozen with the "[Operation]" bulk operation. Audit message showing that an object was frozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Event frozen with the "[Operation]" bulk operation. Reason: "[Change Reason]" Audit message showing that an object was frozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name & "[Change Reason]" is the user-provided reason.
Event remains frozen Audit message stating that the Event remains frozen.
Event remains frozen with the "[Operation]" bulk operation. Audit message showing that an object remained frozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Event unfrozen Audit message stating that the Event was unfrozen.
Event unfrozen with the "[Operation]" bulk operation. Audit message showing that an object was unfrozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Event unfrozen with the "[Operation]" bulk operation. Reason: "[Change Reason]" Audit message showing that an object was unfrozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name & "[Change Reason]" is the user-provided reason.
Event remains unfrozen Audit message stating that the Event remains unfrozen.
Event remains unfrozen with the "[Operation]" bulk operation. Audit message showing that an object remained unfrozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Event locked Audit message stating that the Event was locked.
Event locked with the "[Operation]" bulk operation. Audit message showing that an object was locked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Event locked with the "[Operation]" bulk operation. Reason: "[Change Reason]" Audit message showing that an object was locked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name & "[Change Reason]" is the user-provided reason.
Event remains locked Audit message stating that the Event remains locked.
Event remains locked with the "[Operation]" bulk operation. Audit message showing that an object remained locked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Event unlocked Audit message stating that the Event was unlocked.
Event unlocked with the "[Operation]" bulk operation. Audit message showing that an object was unlocked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Event unlocked with the "[Operation]" bulk operation. Reason: "[Change Reason]" Audit message showing that an object was unlocked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name & "[Change Reason]" is the user-provided reason.
Event remains unlocked Audit message stating that the Event remains unlocked.
Event remains unlocked with the "[Operation]" bulk operation. Audit message showing that an object remained unlocked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Event set as owned by another system. This appears in the system audit, showing that an Event is set by another system (such as IRT, etc.).
Event unset as owned by another system. This appears in the system audit, showing that an Event is no longer set by another system.
Event remains owned by another system. This appears in the system audit, showing that an Event is set by another system and remains as such.
Event remains not owned by another system. This appears in the system audit, showing that an Event is not set by another system and remains as such.
Event Date unsigned. The signature was invalidated because of a change in attestation statement. Audit message stating that the Event Date was unsigned due to its signature definition changing.
The signature was invalidated because of a change in attestation statement Audit message showing that a form or event was unsigned because the signature definition was changed.
"Visit Method" set to "[Visit Method]" Audit message for creating a Visit Method field in an event record.
"Visit Method" changed from "[Visit Method]" to "[Visit Method]" Audit message for editing a Visit Method field in an event record.
"[Visit Method]" was removed from the "Visit Method" field Audit message for removing a Visit Method field in an event record.
Visit Method signed. Signature meaning: "[Signature Meaning]" Audit message stating that the visit method was signed and specifies the legal signature meaning "[Signature Meaning]", configured by study builder.
Visit Method signed Audit message stating that the visit method was signed but the legal signature meaning is unknown.
Visit Method signature broken Audit message stating that the visit method value's signature was broken by a data change.
Visit Method unsigned Audit message stating that the visit method has been unsigned.
Visit Method unsigned. The signature was invalidated because of a change in attestation statement. Audit message stating that the Visit Method object was unsigned due to its signature definition changing.
Visit Method frozen Audit message stating that the Visit Method was frozen.
Visit Method unfrozen Audit message stating that the Visit Method was unfrozen.
Visit Method locked Audit message stating that the Visit Method was locked.
Visit Method unlocked Audit message stating that the Visit Method was unloacked.
"Visit Method SDV Mode" set to "[Review Mode]" Audit message stating that the visit method review SDV requirement mode was set to [Review Mode].Possible “[Review Mode]” strings include:
  • No Review
  • Optional
  • Required
"Visit Method DMR Mode" set to "[Review Mode]" Audit message stating that the visit method review DMR requirement mode was set to [Review Mode].Possible “[Review Mode]” strings include:
  • No Review
  • Optional
  • Required

Form

Potential Audit Trail Message Description
Form: [Form name] created Audit message for creating a form record.
Form: [Form name] deleted Audit message for deleting a form record.
"Change Reason" set to "[Change Reason]" Audit message for creating a Change Reason field in a form record.
"Change Reason" changed from "[Change Reason]" to "[Change Reason]" Audit message for editing a Change Reason field in a form record.
"Form Status" set to "[Status]" Audit message for creating a Form Status field in a form record.
"Form Status" changed from "[Status]" to "[Status]" Audit message for editing a Form Status field in a form record.
"Submission Date" set to "[Date]" Audit message for creating a Submission Date field in a form record.
"Number of Submits" set to "[#]" Audit message for creating a Number of Submits field in a form record.
"Submission Date" changed from "[Date]" to "[Date]" Audit message for editing the Submission Date field in a form record.
"Number of Submits" changed from "[#]" to "[#]" Audit message for editing the Number of Submits field in a form record.
Form signed. Signature Meaning: "[Meaning]" Audit message stating that the form was signed and specifies the legal signature meaning.
Form signed. Audit message stating that the form was signed but the legal signature meaning is unknown.
Form unsigned Audit message stating that the form has been unsigned.
Form frozen Audit message stating that the object was frozen.
Form frozen with the "[Operation]" bulk operation. Audit message showing that an object was frozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Form frozen with the "[Operation]" bulk operation. Reason: "[Change Reason]" Audit message showing that an object was frozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name & "[Change Reason]" is the user-provided reason.
Form remains frozen Audit message stating that the object remains frozen.
Form remains frozen with the "[Operation]" bulk operation. Audit message showing that an object remains frozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Form unfrozen Audit message stating that the object was unfrozen.
Form unfrozen with the "[Operation]" bulk operation. Audit message showing that an object was unfrozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Form unfrozen with the "[Operation]" bulk operation. Reason: "[Change Reason]" Audit message showing that an object was unfrozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name & "[Change Reason]" is the user-provided reason.
Form remains unfrozen Audit message stating that the object remains unfrozen.
Form remains unfrozen with the "[Operation]" bulk operation. Audit message showing that an object remains unfrozen as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Form locked Audit message stating that the object was locked.
Form locked with the "[Operation]" bulk operation. Audit message showing that an object was locked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Form locked with the "[Operation]" bulk operation. Reason: "[Change Reason]" Audit message showing that an object was locked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name & "[Change Reason]" is the user-provided reason.
Form remains locked Audit message stating that the object remains locked.
Form remains locked with the "[Operation]" bulk operation. Audit message showing that an object remains locked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Form unlocked Audit message stating that the object was unlocked.
Form unlocked with the "[Operation]" bulk operation. Audit message showing that an object was unlocked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Form unlocked with the "[Operation]" bulk operation. Reason: "[Change Reason]" Audit message showing that an object was unlocked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name & "[Change Reason]" is the user-provided reason.
Form remains unlocked Audit message stating that the object remains unlocked.
Form remains unlocked with the "[Operation]" bulk operation. Audit message showing that an object remains unlocked as part of a bulk operation, where "[Operation]" is the Bulk Operation Filter name.
Form unsigned. The signature was invalidated because of a change in attestation statement. Audit message stating that the form was unsigned due to its signature definition changing.
"Intentionally Left Blank Reason" set to "[Change Reason]" Audit message for creating an Intentionally Left Blank Reason field in a form record.
"[Change Reason]" was removed from the "Intentionally Left Blank" field Audit message for deleting an Intentionally Left Blank Reason field from a form record.
"Intentionally Left Blank" set to "True" Audit message for creating an Intentionally Left Blank field in a form record.
"Intentionally Left Blank" changed from "False" to "True" Audit message for editing an Intentionally Left Blank field in a form record.
"Intentionally Left Blank" changed from "True" to "False" Audit message for editing an Intentionally Left Blank field in a form record.
"Marked for Removal" set to "True" Audit message for creating a Marked for Removal field in a form record.
"Marked for Removal" changed from "True" to "False" Audit message for editing a Marked for Removal field in a form record.

Item

Potential Audit Trail Message Description
Item: [Item Name] created Audit message for creating an item record.
Item: [Item name] modified Audit message for editing an item record.
Item: [Item Name] deleted Audit message for deleting an item record.
"SDV Mode" set to "[Review Mode]" Audit message for creating an SDV Mode field in an item record.
"DMR Mode" set to "[Review Mode]" Audit message for creating a DMR Mode field in an item record.
"SDV Mode" changed from "[Review Mode]" to "[Review Mode]" Audit message for editing the SDV field in an item record.
"DMR Mode" changed from "[Review Mode]" to "[Review Mode]" Audit message for editing the DMR Mode field in an item record.
Derived display value set to "[1] [2]". Audit message stating that an item's value [1] with unit [2] was initially set based on values from another item.
Derived display value set to "[1]". Audit message stating that an item's value [1] was initially set based on values from another item.
Derived display value set to "[0][1] [2]". Audit message stating that a lab item's value [1] with modifier [0] and unit [2] was initially set based on values from another item. (A modifier is a symbol like > or < )
Derived display value set to "[0][1]". Audit message stating that an item's value [1] with modifier [0] was initially set based on values from another item. (A modifier is a symbol like > or < )
Derived display value is "[1] [2]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's value is [1] with unit [2] and remains unchanged while the change reason was altered.
Derived display value is "[1]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's value is [1] and remains unchanged while the change reason was altered from [2] to [3].
Derived display value is "[0][1] [2]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's value is [1] with modifier [0] and unit [2] and remains unchanged while the change reason was altered.
Derived display value is "[0][1]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's value is [1] with modifier [0] and remains unchanged while the change reason was altered.
Derived display value is blank. Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's value is blank and remains unchanged while the change reason was altered.
Derived display value changed from "[1] [2]" to "[3] [4]". Audit message stating that an item's value was changed from [1] with unit [2] to [3] with unit [4] based on values from another item.
Derived display value changed from "[1] [2]" to blank. Audit message stating that an item's value was set to blank from [1] with unit [2] based on values from another item.
Derived display value changed from "[1]" to "[2]". Audit message stating that an item's value was changed from [1] to [2] based on values from another item.
Derived display value changed from "[1]" to blank. Audit message stating that an item's value was set to blank from [1] based on values from another item.
Derived display value changed from "[0][1] [2]" to "[3][4] [5]". Audit message stating that an item's value was changed from [1] with modifier [0] and unit [2] to [4] with modifier [3] and unit [5] based on values from another item. (A modifier is a symbol like > or < )
Derived display value changed from "[0][1] [2]" to blank. Audit message stating that a lab item's value was set to blank from [1] with modifier [0] and unit [2] based on values from another item. (A A modifier is a symbol like > or <)
Derived display value changed from "[0][1]" to "[2][3]". Audit message stating that an item's value was changed from [1] with modifier [0] to [3] with modifier [2] based on values from another item.
Derived display value changed from "[0][1]" to blank. Audit message stating that an item's value was set to blank from [1] with modifier [0] based on values from another item. (A A modifier is a symbol like > or <)
Derived display value changed from "Intentionally Left Blank: [Reason]" to "[1] [2]". Audit message stating that an item was changed from intentionally blank with reason "[Reason]" to having a value [1] with unit [2] based on values from another item.
Derived display value changed from "Intentionally Left Blank: [Reason]" to "[1]". Audit message stating that an item was changed from intentionally blank with reason "[Reason]" to having a value [1] based on values from another item.
Derived display value changed from "Intentionally Left Blank: [Reason]" to "[0][1] [2]". Audit message stating that an item was changed from intentionally blank with reason "[Reason]" to having a value [1] with modifier [0] and unit [2] based on values from another item.
Derived display value changed from "Intentionally Left Blank: [Reason]" to "[0][1]". Audit message stating that an item was changed from intentionally blank with reason "[Reason]" to having a value [1] with modifier [0] based on values from another item.
Derived display translated value set to "[1] [2]". Audit message stating that an item's translated value (converted from another unit) [1] and unit [2] was initially set based on values from another item.
Derived display translated value set to "[0][1] [2]". Audit message stating that an item's translated value (converted from another unit) [1] with modifier [0] and unit [2] was initially set based on values from another item. (A modifier is a symbol like >, <)
Derived display translated value set to "[0][1]". Audit message stating that an item's translated value (converted from another unit) [1] with modifier [0] was initially set based on values from another item. (A A modifier is a symbol like > or <)
Derived display translated value changed from "[1] [2]" to "[3] [4]". Audit message stating that an item's translated value (converted from another unit) was changed from [1] with unit [2] to [3] with unit [4] based on values from another item.
Derived display translated value changed from "[1] [2]" to blank. Audit message stating that an item's translated value (converted from another unit) was set to blank from [1] with unit [2] based on values from another item.
Derived display translated value changed from "[0][1] [2]" to "[3][4] [5]". Audit message stating that an item's translated value (converted from another unit) was changed from [1] with modifier [0] and unit [2] to [4] with modifier [3] and unit [5] based on values from another item.
Derived display translated value changed from "[0][1] [2]" to blank. Audit message stating that an item's translated value (converted from another unit) was set to blank from [1] with modifier [0] and unit [2] based on values from another item. (Modifier is >, <)
Derived display translated value changed from "[0][1]" to "[2][3]". Audit message stating that an item's translated value (converted from another unit) was changed from [1] with modifier [0] to [3] with modifier [2] based on values from another item.
Derived display translated value changed from [0][1] to blank. Audit message stating that an item's translated value (converted from another unit) was set to blank from [1] with modifier [0] based on values from another item. (Modifier is >, <)
Derivation submit value entered "[1]". Audit message stating that the unitless derivation submit value [1] was initially set.
Derivation submit value entered "[1] [2]". Audit message stating that the derivation submit value [1] with unit [2] was initially set.
Derivation submit value translated set to "[1] [2]". As a result of a user action, the translated (converted to a standard unit of measure) derivation submit value was set from blank. [1] is the numeric value and [2] is the unit.
Derivation submit value is "[1] [2]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the derivation submit value is [1] with unit [2], and the change reason was modified.
Derivation submit value is "[1]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the unitless derivation submit value is [1], and the change reason was modified.
Derivation submit value is blank. Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the derivation submit value is blank, and the change reason was modified.
Derivation submit value set as Intentionally Left Blank with reason "[Reason]". Audit message stating that the derivation submit value was set to Intentionally Left Blank for the reason "[Reason]"
Derivation submit value unset as Intentionally Left Blank. Audit message stating that the derivation submit value was unset from Intentionally Left Blank
Derivation submit value changed from "[1] [2]" to "[3] [4]". Audit message stating that the derivation submit value [1] with unit [2] was changed to another value [3] with unit [4].
Derivation submit value changed from "[1] [2]" to blank. Audit message stating that the derivation submit value [1] with unit [2] was removed and replaced with nothing.
Derivation submit value changed from "[1]" to "[2]". Audit message stating that the unitless derivation submit value was changed from [1] to [2].
Derivation submit value changed from "[1]" to blank. Audit message stating that the unitless derivation submit value [1] was removed and replaced with nothing.
Derivation submit value translated changed from "[1] [2]" to "[3] [4]". As a result of a user action, the translated (converted to a standard unit of measure) derivation submit value was changed. [1] and [3] are the numeric values and [2] and [4] are the units.
Derivation submit value translated changed from "[1] [2]" to blank. As a result of a user action, the translated (converted to a standard unit of measure) derivation submit value was removed and replaced with nothing. [1] is the numeric value and [2] is the unit.
Exam uploaded "[Exam Name]". Audit message stating that the imaging exam [Exam Name] was initially uploaded.
Exam deleted "[Exam Name]". Audit message stating that the imaging exam [Exam Name] is deleted.
Item DMR set to "True" Audit message stating that DMR was performed.
Item DMR set to "True" with additive reason: "[Additive Reason]" Audit message stating that additive DMR was performed.
Item DMR set to "False" Audit message stating that DMR was undone.
Item SDV set to "True" Audit message stating that SDV was performed.
Item SDV set to "True" with additive reason: "[Additive Reason]" Audit message stating that additive SDV was performed.
Item SDV set to "False" Audit message stating that SDV was undone.
"User Review Modified By" set to "[User]" Audit message stating that the User Review Modified By field was set; [User] is the user display name.
"User Review Modified By" changed from "[User]" to blank. Audit message stating that the User Review Modified By field was cleared; [User] was the user display name before clearing.
Item frozen Audit message stating that the object was frozen.
Item frozen with the "[Operation]" bulk operation. This appears in the system audit, showing that an object was frozen as part of a bulk operation. "[Operation]" is the Bulk Operation Filter name.
Item remains frozen Audit message stating that the object remains frozen.
Item remains frozen with the "[Operation]" bulk operation. This appears in the system audit, showing that an object remained frozen as part of a bulk operation. "[Operation]" is the Bulk Operation Filter name.
Item remains unfrozen Audit message stating that the object remains unfrozen.
Item remains unfrozen with the "[Operation]" bulk operation. This appears in the system audit, showing that an object remained unfrozen as part of a bulk operation. "[Operation]" is the Bulk Operation Filter name.
Item unfrozen Audit message stating that the object was unfrozen.
Item unfrozen with the "[Operation]" bulk operation. This appears in the system audit, showing that an object was unfrozen as part of a bulk operation. "[Operation]" is the Bulk Operation Filter name.
Item set as Intentionally Left Blank with reason "[Reason]". Audit message stating that the item was set to Intentionally Left Blank for the reason "[Reason]"
Item unset as Intentionally Left Blank. Audit message stating that the item was unset from Intentionally Left Blank.
Item set as owned by another system. This appears in the system audit, showing that an object is set by another system.
Item remains not owned by another system. This appears in the system audit, showing that an object is not set by another system and remains as such.
Item remains owned by another system. This appears in the system audit, showing that an object is set by another system and remains as such.
Item unset as owned by another system. This appears in the system audit, showing that an object is no longer set by another system.
Migration removed "[Codelist value]" from the Codelist Item Definition. Audit row showing the codelist value removed during the lab migration process
Migration removed Translated Unit Value "[Value]". Audit row showing the translated unit value removed during the lab migration process (translated here being "converted to standard unit", not linguistically translated).
Migration removed Unit Value "[Value]". Audit row showing the unit value removed during the lab migration process.
Migration set Lab Codelist Value set to "[Value]". Audit row showing the lab codelist value added during the lab migration process.
Migration set Lab Unit Value to "[Value]". Audit row showing the lab unit value added during the lab migration process.
Migration set Translated Lab Unit Value to "[Value]". Audit row showing the translated lab unit value added during the lab migration process (translated here being "converted to standard unit", not linguistically translated).
Query Answered: "[Query Message]" Audit message stating that a query was answered; "[Query Message]" is the message the user entered.
Query Changed Audit message stating that a query was changed when there is no known message.
Query Changed: "[Query Message]" Audit message stating that a query was changed; "[Query Message]" is the message the user entered.
Query Closed Audit message stating that a query was closed with no message appended.
Query Closed: "[Query Message]" Audit message stating that a query was closed; "[Query Message]" is the message the user entered.
Query Deleted: "[Query Message]" Audit message stating that a query was deleted; "[Query Message]" was the message the user first entered.
Query Opened: "[Query Message]" Audit message stating that a query was opened; "[Query Message]" is the message the user entered.
Query Reopened: "[Query Message]" Audit message stating that a query was reopened; "[Query Message]" is the message the user entered.
Translated value changed from "[1] [2]" to "[3] [4]". As a result of a user action, the translated (converted to a standard unit of measure) value was changed. [1] and [3] are the numeric values and [2] and [4] are the units.
Translated value changed from "[1] [2]" to blank. As a result of a user action, the translated (converted to a standard unit of measure) value was unset. [1] is the numeric value and [2] is the unit.
Translated value changed from "[0][1] [2]" to "[3][4] [5]". Audit message stating that the item's translated value [1] with modifier [0] and translated unit [2] was changed to another translated value [4] with modifier [3] and translated unit [5].
Translated value changed from "[0][1] [2]" to blank. Audit message stating that the item's translated value [1] with modifier [0] and translated unit [2] was removed and replaced with nothing.
Translated value changed from "[0][1]" to "[2][3]". Audit message stating that the item's translated number value [1] with modifier [0] was changed to another translated value [3] with modifier [2].
Translated value changed from "[0][1]" to blank. Audit message stating that the item's translated number value [1] with modifier (such as "<", or ">") [0] was removed and replaced with nothing.
Translated value set to "[1] [2]". As a result of a user action, the translated (converted to a standard unit of measure) value was set from blank. [1] is the numeric value and [2] is the unit.
Translated value set to "[0][1] [2]". Audit message stating that the item's translated value [1] with modifier [0] and translated unit [2] was initially set.
Translated value set to "[0][1]". Audit message stating that the item's translated number value [1] with modifier (such as "<", or ">") [0] was initially set.
Value entered "[1] [2]". Audit message stating that the item's value [1] with unit [2] was initially set.
Value entered "[1]". Audit message stating that the item's unitless value [1] was initially set.
Value entered "[0][1] [2]". Audit message stating that the lab item's value [1] with modifier [0] and unit [2] was initially set.
Value entered "[0][1]". Audit message stating that the lab item's number value [1] with modifier (such as "<", or ">") [0] was initially set.
Value is "[1] [2]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's value is [1] with unit [2], and the change reason was updated from "[Change Reason]" to "[Change Reason]".
Value is "[1]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's unitless value is [1], and the change reason was updated from "[Change Reason]" to "[Change Reason]".
Value is "[0][1] [2]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's value [1] with modifier [0] and unit [2], and the change reason was updated from "[Change Reason]" to "[Change Reason]".
Value is "[0][1]". Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's number value [1] with modifier [0], and the change reason was updated from "[Change Reason]" to "[Change Reason]".
Value is blank. Change Reason changed from "[Change Reason]" to "[Change Reason]". Audit message stating that the item's value is blank, and the change reason was updated from "[Change Reason]" to "[Change Reason]".
Value changed from "[1] [2]" to "[1]". Audit message stating that the item's unit [2] was removed while the value [1] remained.
Value changed from "[1] [2]" to "[3] [4]". Audit message stating that the item's value [1] with unit [2] was changed to another value [3] with unit [4].
Value changed from "[1] [2]" to blank. Audit message stating that the item's value [1] with unit [2] was removed and replaced with nothing.
Value changed from "[1]" to "[2]". Audit message stating that the item's unitless value was changed from [1] to [2].
Value changed from "[1]" to blank. Audit message stating that the item's unitless value [1] was removed and replaced with nothing.
Value changed from "[0][1] [2]" to "[3][4] [5]". Audit message stating that the item's value [1] with modifier [0] and unit [2] was changed to another value [4] with modifier [3] and unit [5].
Value changed from "[0][1] [2]" to blank. Audit message stating that the lab item's value [1] with modifier [0] and unit [2] was removed and replaced with nothing. ( A A modifier is a symbol like > or <)
Value changed from "[0][1]" to "[2][3]". Audit message stating that the item's number value [1] with modifier [0] was changed to another value [3] with modifier [2].
Value changed from "[0][1]" to blank. Audit message stating that the item's number value [1] with modifier (such as "<", or ">") [0] was removed and replaced with nothing.
Value changed from "Intentionally Left Blank: [Reason]" to "[1] [2]". Audit message stating that the item's value was changed from Intentionally Left Blank with reason "[Reason]" to another value [1] with unit [2].
Value changed from "Intentionally Left Blank: [Reason]" to "[1]". Audit message stating that the item's unitless value was changed from Intentionally Left Blank with reason "[Reason]" to [1].
Value changed from "Intentionally Left Blank: [Reason]" to "[0][1] [2]". Audit message stating that the item's value was changed from Intentionally Left Blank with reason "[Reason]" to another value [1] with modifier [0] and unit [2].
Value changed from "Intentionally Left Blank: [Reason]" to "[0][1]". Audit message stating that the item's number value was changed from Intentionally Left Blank with reason "[Reason]" to another value [1] with modifier [0].
[0] Reason for change: "[Change Reason]". [0] is an audit sentence; this Audit message stating that that statement's reason for change is "[Change Reason]".

Item Group

Potential Audit Trail Message Description
Item Group: [Item Group Name] created Audit message for creating an item group record.
Item Group: [Item Group Name] deleted Audit message for deleting an item group record.
Item Group: [Item group name] modified Audit message for editing an item group record.
"Change Reason" set to "[Reason]" Audit message for creating a Change Reason field in an item group record.
"Change Reason" changed from "[Reason]" to "[Reason]" Audit message for editing a Change Reason field in an item group record.
"Intentionally Left Blank Reason" set to "[Reason]" Audit message for creating an Intentionally Left Blank Reason field in an item group record.
"Intentionally Left Blank" changed from "False" to "True" Audit message for editing an Intentionally Left Blank field in an item group record.
"Intentionally Left Blank" changed from "True" to "False" Audit message for editing an Intentionally Left Blank field in an item group record.
"Intentionally Left Blank" set to "True" Audit message for creating an Intentionally Left Blank field in an item group record.
Potential Audit Trail Message Description
"[Form Name](Seq #)" link to "[Form Name](Seq #)" created. Audit trail message that says two forms were linked. "[Event/Form Label]" represents the event/form labels.
"[Form Name](Seq #)" link to "[Form Name](Seq #)" deleted. Audit trail message that says two forms were unlinked. "[Event/Form Label]" represents the event/form labels.

Protocol Deviation

Potential Audit Trail Message Description
"Category" changed from "[PD Category]" to "[PD Category]" Audit message for editing the Category field for a Protocol Deviation.
"Date of Deviation" changed from "[Date]" to "[Date]" Audit message for editing the Date of Deviation field for a Protocol Deviation.
"Description" set to "[Description]" Audit message for setting a Description field for a Protocol Deviation.
"Description" changed from "[description]" to "[description]" Audit message for editing the Description field for a Protocol Deviation.
"Inactivated by System" set to "True" Audit message for setting the Inactivated by System field in a Protocol Deviation to True.
"Last Inactivated Date" set to "[Date]" Audit message for setting a Last Inactivated Date field in a Protocol Deviation.
"Protocol Deviation Status" changed from "[Status]" to "[Status]" Audit message for editing the Protocol Deviation Status field for a Protocol Deviation.
"Resolution" set to "[Resolution]" Audit message for creating the Resolution field for a Protocol Deviation.
"Resolution" changed from "[Resolution]" to "[Resolution]" Audit message for editing the Resolution field for a Protocol Deviation.
"Severity" changed from "[Severity]" to "[Severity]" Audit message for editing the Severity field for a Protocol Deviation.
"Subcategory" changed from "[Subcategory]" to "[Subcategory]" Audit message for editing the Subcategory field for a Protocol Deviation.
"Summary" changed from "[Summary]" to "[Summary]" Audit message for editing the Summary field for a Protocol Deviation.
"User Modified By" changed from "[User]" to "[User]" Audit message for editing the User Modified By field for a Protocol Deviation.
"User Modified By" set to "[User]" Audit message for creating the User Modified By field for a Protocol Deviation.
"User Modified Date" changed from "[Datetime]" to "[Datetime]" Audit message for editing the User Modified Date field for a Protocol Deviation.
"User Modified Date" set to "[Datetime]" Audit message for creating the User Modified Date field for a Protocol Deviation.
Protocol Deviation: [PD Name] created Audit message for creating a Protocol Deviation.

Coder

Potential Audit Trail Message Description
[Coding Status]: The Coding Request is [Coding Status] from the [Coding Source] action for [LLT Code] - [LLT Name], [PT Code] - [PT Name], [HLT Code] - [HLT Name], [HLGT Code] - [HLGT Name], [SOC Code] - [SOC Name] Primary Path: [Y/N] Audit message for setting the "[Coding Status]" field in Coding Request records from Forms configured with a MedDRA dictionary. Possible “[Coding Status]” strings include:
  • Open
  • Uncoded
  • Updated
  • Pending Approval
  • Coded
  • Autocoded
  • Rejected
  • Noncurrent
[Coding Status]: The Coding Request is [Coding Status] from the [Coding Source] action for [Drug Code] - [Drug Name], [Preferred Code] - [Preferred Name] Audit message for setting the "[Coding Status]" field in Coding Request records from Forms configured with WHODrug dictionary without ATCs. Possible “[Coding Status]” strings include:
  • Open
  • Uncoded
  • Updated
  • Pending Approval
  • Coded
  • Autocoded
  • Rejected
  • Noncurrent
[Coding Status]: The Coding Request is [Coding Status] from the [Coding Source] action for [Drug Code] - [Drug Name], [Preferred Code] - [Preferred Name], [ATC4 Code] - [ATC4 Name], [ATC3 Code] - [ATC3 Name], [ATC2 Code] - [ATC2 Name], [ATC1 Code] - [ATC1 Name] Audit message for setting the "[Coding Status]" field in Coding Request records from Forms configured with WHODrug dictionary with ATCs. Possible “[Coding Status]” strings include:
  • Open
  • Uncoded
  • Updated
  • Pending Approval
  • Coded
  • Autocoded
  • Rejected
  • Noncurrent
[Coding Status]: The Coding Request was [approved / rejected] for [Code] Audit message when a Coding Request in Pending Approval status is approved or rejected. Possible Coding Statuses include:
  • Coded
  • Autocoded
  • Rejected
[Coding Status]: The Coding Request is [coding status] from the [External Suggestion Def Name] for [Code] For studies with [External Suggestions](/ko/lr/coders/using-the-coding-panel/#external-suggestions) enabled, the audit message when the Coding Status for a Code Request is set from an external suggestion.
Remapped: The Coding Request was remapped to [Code] Audit message when a Code Request is remapped during versioning.
"[Attribute]" set to "[Value]" Audit message for other attributes. See list of [attributes](/ko/lr/study-administrators/potential-audit-descriptions/#coder-attributes-included-in-the-audit-trail).
[Medical Coding Query Status]: [Query Message] Audit message when a Code Request Query associated with a Code Request is created or updated. Possible Query Statuses include:
  • Query to Site
  • Site Responded
  • Re-Queried Site
Closed Query Audit message when a Code Request Query is closed without a message.
Closed Query: [Query Message] Audit message when a Code Request Query is closed with a message.
[Note Status (Posted Note / Deleted Note)]: [Note] Audit message when a Medical Coding Note associated with a Code Request is created or deleted.
Edited Note: [old note message] changed to [new note message] Audit message when a Medical Coding Note associated with a Code Request is edited.

Coder Attributes Included in the Audit Trail

  • ae_action_taken__v
  • ae_severity__v
  • ae_relationship__v
  • ae_outcome__v
  • ae_expected_outcome__v
  • ae_seriousness__v
  • assigned_to__v
  • assigned_to_third_party__v
  • autocoding_source__v
  • autocoding_suggestion_record__v
  • mc_synonym_list__v
  • mc_synonym_list_detail__v
  • autocoding_type__v
  • indication_stems__v
  • verbatim_stems__v
  • route_stems__v
  • lifecycle__v
  • cm_dose__v
  • cm_frequency__v
  • cm_indication__v
  • cm_course_num__v
  • cm_route__v
  • cm_dose_unit__v
  • item_def__v
  • mc_item_def__v
  • dictionary_def__v
  • item__v
  • related_item__v
  • status__v
  • state__v
  • study__v
  • event__v
  • stop_date__v
  • start_date__v
  • form__v
  • manual_coding_source__v (included in Coding Audit Entries but also has a standalone audit entry)
  • related_itemgroup__v
  • itemgroup__v
  • autocoding_suggestion_record_external_id__v
  • last_coded_by_third_party__v
  • verbatim__v
  • sponsor__v
  • study_country__v
  • dictionary_release__v
  • event_seq__v
  • form_seq__v
  • itemgroup_seq__v
  • site__v
  • subject__v
  • source_type__v