Include subject event history in your Oracle CRF Submit Archive requests

Pre-General Availability: 2025-07-15

Include subject event history in your Oracle CRF Submit Archive requests

Sponsor and site users can now include details about subject events in Oracle CRF Submit Archives requests.

A new setting, Include Subject Event Data, is now available on the Advanced Settings page when you generate Submission, Archival (sponsor and site), and Custom Archives requests.

When enabled, the subject PDF contains the date and time of each event, as well as other subject event details. For a complete list of details, refer to the table below.

Details for sponsor and site users

This setting, in conjunction with the existing Include RTSM Data setting, determines what data is included in each Archives request.

If Include RTSM Data is set to Yes and Include Subject Event Data is set to No,
- The PDF includes a section labeled Subject Randomization History, which displays the randomization number and the date and time of randomization.
- The PDF also includes a section labeled Visit History, which displays kit and dispensation details.
If Include RTSM Data is set to No and Include Subject Event Data is set to Yes,
- The PDF includes a section labeled Subject Event History, which displays each event (under the Action column) and the date and time of occurrence, as well as other subject event details (under the Details column). For a complete list of details, see the table below.
If both are set to Yes,
- The PDF includes a section labeled Subject History, which displays each event (under the Action column) and the date and time of occurrence, as well as other subject event details (under the Details column). For a complete list of details, see the table below.
- The PDF also includes a section labeled Visit History, which displays kit and dispensation details.
If both are set to No (system default), no sections appear in the output.

You can find additional information in the Reporting Guide after the Release Assessment Environment (RAE) upgrade.

What event details are included when the setting Include Subject Event Data is set to Yes?

The details below are listed in the order they appear in the PDF.

Table 2-1 Details included with each event

Event	Details included for each event
New Subject	Date: Displays the date and time when the subject was added. User: Displays the user who added the subject.
Screened	Date: Displays the date and time when the subject was screened. User: Displays the user who screened the subject.
Screen Failed	Reason: Displays the Reason for Screen Fail selected. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Screen Fail. Date of screen failed: Displays the Date of Screen Fail selected. If a date is not selected, the date and time the event occurred is displayed. Date: Displays the date and time the user screen failed the subject, which could be different than the Date of Screen Fail selected. User: Displays the user who screen failed the subject.
Screen Fail Update	Reason: If a new reason is selected, that is displayed. If not, the original Reason for Screen Fail value selected when the subject was screen failed is displayed. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Screen Fail. Date of update screen fail: If a new Date of Screen Fail is selected, that is displayed. The date selected when the subject originally screen failed is shown if no new selection is made. If a date was not selected when the subject originally screen failed, then the date and time the Screen Fail event occurred is displayed. Reason for change: Displays the Reason for Change selected. Reason for change comment: Displays the Other Reason text entered when Other is selected as the Reason for Change. Date: Displays the date and time the user edited the screen fail details. User: Displays the user who edited the screen fail details.
Reinstated (Undo Screen Fail)	Reason: Displays the Reason for Change selected. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Change. Date: Displays the date and time the screen fail was undone by the user. User: Displays the user who completed the undo screen fail event.
Subject Enrolled	Date: Displays the date and time the subject was enrolled. User: Displays the user who enrolled the subject.
Randomized	Number: Displays the randomization number assigned to the subject. Date: Displays the date and time the subject was randomized.
Randomization number assigned to subject number	If you are working in a study that takes advantage of the ability to replace the subject number with the randomization number, the output includes the following. Date: Displays the date and time the subject number was replaced with the randomization number. Screening Number: Displays the original Screening Number assigned to the subject before it was replaced by the randomization number. User: Displays the user who randomized the subject. For more information about this feature, see Replace a subject number with the randomization number.
Withdrawn	Reason: Displays the Reason for Withdrawal selected. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Withdrawal. Date of withdrawal: Displays the Date of Withdrawal selected. Date: Displays the date and time the user withdrew the subject, which could be different than the Date of Withdrawal selected. User: Displays the user who withdrew the subject.
Reinstated (Undo Withdrawal)	Reason: Displays the Reason for Change selected. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Change. Date: Displays the date and time withdrawal was undone by the user. User: Displays the user who completed the undo withdrawal event.
Withdrawal Update	Reason: If a new reason is selected, that is displayed. If not, the original Reason for Withdrawal value selected when the subject was withdrawn is displayed. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Withdrawal. Date of update withdrawal: Displays the new Date of Withdrawal selected. If a new date was not selected, the original date and time of withdrawal is displayed. Reason for change: Displays the Reason for Change selected. Reason for change comment: Displays the Other Reason text entered when Other is selected as the Reason for Change. Date: Displays the date and time the user edited the withdrawal details. User: Displays the user who edited the withdrawal details.
Study Completed	Date of study complete: Displays the Date of Completion selected. Date: Displays the date and time the user processed the study complete event, which could be different than the Date of Completion selected. User: Displays the user who processed the study complete event.
Reinstated (Undo Study Complete)	Reason: Displays the Reason for Change selected. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Change. Date: Displays the date and time study completion was undone by the user. User: Displays the user who processed the undo study complete event.
Completion Update	Reason: Displays the Reason for Change selected. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Change. Date of update completion: Displays the new Date of Completion selected. If a new date is not selected, the original study completion date and time is displayed. Date: Displays the date and time the user edited the completion details. User: Displays the user who edited the completion details.
Subject Number Changed	Reason: Displays Other by default. Reason Comment: Displays the Reason for Change text entered. Previous subject number: Displays the subjects previous subject number. Date: Displays the date and time the subject number was changed. User: Displays the user who changed the subject number.
Subject-patient Link Created	Date: Displays the date and time the user linked the subject for Electronic Health Record (EHR) data import. For more information, see EHR data import. User: Displays the user who linked the subject for EHR data import.
Subject-patient Link Removed	Reason Comment: Displays the text entered, indicating why the subject-patient link was removed. Date: Displays the date and time the subject-patient link was removed. User: Displays the user who removed the subject-patient link.
Code Break	Reason: Displays Code Break by default. For more information, see Unblind a subject's treatment arm (code break). Reason Comment: Displays the selection made for Adverse Event (Yes or No) when the code break event was completed. Date: Displays the date and time the code break event was completed. User: Displays the user who completed the code break event.
Visit Skipped	Reason: Displays the Reason for Change selected. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Change. Visit Name: Displays the name of the skipped visit. Date: Displays the date and time the visit was skipped. User: Displays the user who skipped the visit.
Undo Visit Skipped	Reason: Displays the Reason for Change selected. Reason Comment: Displays the Other Reason text entered when Other is selected as the Reason for Change. Visit Name: Displays the name of the visit that was previously skipped. Date: Displays the date and time the visit was unskipped. User: Displays the user that unskipped the visit.

Parent topic: Reporting, archives and analytics