OnCore: Subject Console / SAE DFD (to be moved into 86170 when approved)

 

Data Field Definitions for SAEs
Field Name Definition Requirement
Entry Instructions		 Responsible for Entry QA
Subject SAE Update section
Event Date The date the adverse event became serious (i.e., met at least one of the seriousness criteria per protocol). Required CRA Console edit / Subject Coordinator Yes
Event End Date The date the toxicity ended or is no longer considered serious. Required
 CRA Console edit / Subject Coordinator No
Reported Date The date the research staff was notified of the SAE. Required

For example, the date the research staff was notified of the event by the subject or by someone else on the subject's behalf.

Note: This date does not change between initial and follow up reports.		 CRA Console edit / Subject Coordinator No
Reported By The name of the person who is the contact for questions on the SAE. Required CRA Console edit / Subject Coordinator No
Death Date The date of death. Required in the situations described

Complete if related to the SAE.		 CRA Console edit / Subject Coordinator No
Death Occurred The number of days after the last treatment date that the subject died. Required in the situations described

Complete if death is related to the SAE and Death Date is entered.
  • After 100 days
  • Death while on treatment
  • Prior to starting treatment
  • Within 100 days
  • Within 30 days
 CRA Console edit / Subject Coordinator No
Did SAE occur at your site or at a site for which the PI is responsible? This field refers to the site where the subject is participating on the study, not the location where the actual SAE occurred and/or was treated. Required

Answer yes if any of the following criteria is met:
  1. subject participating at UWCCC
  2. subject participating at affiliate site on UWCCC IIT study
  3. subject participating at an affiliate site where UW faculty is/are involved in the study
 CRA Console edit / Subject Coordinator No
Event Narrative A detailed narrative text describing the presentation of the event, the clinical findings, the treatment of the events, and the timing of events related to agent administration or investigational intervention. Required

If no treatment given on this protocol, state this.

The following information is REQUIRED:
  • The date of the subject's last treatment prior to the onset of the SAE.
  • A statement as to whether you are planning to submit a follow up report or not.
  • If protocol treats more than one tumor type, please include the subject's primary cancer diagnosis.

If submission via CTEP-AERS is required for the study, the SAE Coordinator will enter the following:
  • NCI CTEP-AERS ticket #: [ticket number]
    • This information should not be deleted.
 CRA Console edit / Subject Coordinator No
Treating Physician Comments A narrative text for the treating physician comments. Not Required CRA Console edit / Subject Coordinator No
PI Comments A narrative text stating the rationale for an attribution, expectation, or drug combination, if an explanation is necessary. Not Required CRA Console edit / Subject Coordinator No
Protocol Attribution Not currently used at the UWCCC CRA Console edit / Subject Coordinator No
Outcome Select the outcome for the primary SAE. Required

Drop-down list:
  • Fatal / Died
  • Intervention for AE Continues
  • Not Recovered / Not Resolved
  • Recovered / Resolved with Sequelae
  • Recovered / Resolved without Sequelae
  • Recovering / Resolving
 CRA Console edit / Subject Coordinator No
Consent Form Change Required? Required

Select Yes if the consent form will be changed due to the SAE. Select No if it will not be changed.		 CRA Console edit / Subject Coordinator No
SAE Classification Required

Click the Select button to view the menu. Check all that apply and click Add. In addition, select 24-48 Hour SAE if applicable per the protocol.		 CRA Console edit / Subject Coordinator No
Report to IRB? Required

Select the timeframe in which the SAE will be reported to the IRB if applicable.
  • Not Required: use when reporting to the IRB is not required
  • Immediately: use when IRB reporting is required within 24 to 48 hours of knowledge of the event.
  • Within X Business Days: use when IRB reporting is required by a defined number of business days other tan 24-48 hours. Also note in the narrative when reporting is required.
    • Example: Report to IRB within 14 business days.
OnCore Support Note: Required for RRN		 CRA Console edit / Subject Coordinator No
Adverse Event Details section
Course Start The start date of the intervention or course in which the toxicity occurred. Not Required

Oncology: If no treatment given on study, leave blank.		 CRA Console edit / Subject Coordinator No
Category Required

Best Practice: click the "Select Detail..." hyperlink to the right of the Grade/Severity field to display the listing of adverse events from the protocol's toxicity scheme (as entered in the PC Console / Main / Management / Toxicity Scheme field) and select the toxicity directly from the hyperlink.

Notes:
  • Within the hyperlink, AE Description = AE Detail and AE Category = Category.
  • Manual selection of each field is not recommended, as a non-existent grade for an AE (ex. toxicity 5 (fatal) for Alopecia) could be selected.
  • If the sponsor/protocol does not use CTCAE, select the closest option.
 CRA Console edit / Subject Coordinator No
AE Detail Required

Follow best practice in Category field (above) for selection.		 CRA Console edit / Subject Coordinator No
Grade / Severity Required

Follow best practice in Category field (above) for selection.		 CRA Console edit / Subject Coordinator No
Unexpected Required 

Select Yes if the toxicity does not meet the "expected" criteria listed in at least one protocol document. Otherwise, select No.

Use the "PI Comments" field if additional information needs to be noted.		 CRA Console edit / Subject Coordinator No
DLT Dose Limiting Toxicity. Required

Select Yes if the primary SAE is a dose-limiting toxicity. If not, select No.

Note: If your study protocol does not mention DLTs in an attempt to find a maximum tolerated dose or for moving on to the next cohort, the answer to this field is No.		 CRA Console edit / Subject Coordinator No
Action  Required

Select the change made to the study regimen in response to the toxicity.		 CRA Console edit / Subject Coordinator No
Therapy  Required

Select the additional therapy required to treat the toxicity:
  • None
  • Symptomatic (for example, over-the-counter medications)
  • Supportive (for example, prescription medications, IV fluids, blood products)
  • Vigorous Supportive (for example, surgery, intubation)
 CRA Console edit / Subject Coordinator No
Comments A free text field for comments. Not Required

Toxicity field: If "Other" is selected for Toxicity, explain here.

Source/Attribution = Other and/or NonInvTx field: If "Other" and/or"NonInvTx" under Source/Attribution, is indicated to be Possible, Probable, or Definite, explain here.
  • Example: /Attribution Other - care accident
 CRA Console edit / Subject Coordinator No
Source / Attribution subsection
Investigational Therapy The attribution for the toxicity as it related to therapy(ies)/treatment(s) (e.g., drug, device, radiotherapy) under study in the protocol. Required

These therapy(ies)/treatment(s) are pull from the applicable arm(s) built in the Treatment tab. If more than one therapy/treatment is administered, the Investigational Therapy field (InTx) must match the highest attribution assigned.		 CRA Console edit / Subject Coordinator No
Non-Investigational Therapy The attribution for therapy(ies)/treatment(s)/procedure(s) not under study in the protocol. Required

Examples:
  • Blood pressure medication prescribed for hypertension that is not being studied on the protocol
  • Cataract surgery performed in clinical practice, not assigned by the protocol
  • Prophylactic or supportive care drug being given per protocol that is not also being studied on the protocol
  • Therapy/treatment prescribed/administered clinically only, with no assignment/randomization within the study protocol
If the non-investigational field has an attribution of possible, probable, or definite, the non-investigational therapy(ies)/treatment(s)/procedure(s) must be defined in the AE Details Comment field.		 CRA Console edit / Subject Coordinator No
Drugs/Devices The attribution for each drug/device listed in the PC Console / Treatment / Details field.  Required

Note: If there is more than one investigational drug/device, the attribution of the Investigational Therapy should match the highest attribution assigned to the drug/device.		 CRA Console edit / Subject Coordinator No
Last Dose/Treatment Date The last date of dose of the corresponding drug prior to the onset of the SAE. Required CRA Console edit / Subject Coordinator No
Disease The attribution as it relates to the subject's disease. Required CRA Console edit / Subject Coordinator No
Other The attribution for any other event (Not directly related to the study, e.g., car accident). Required

If attribution of Possible, Probable, or Definite is selected, explain in the Toxicity Comments field indicating what the other event is.		 CRA Console edit / Subject Coordinator No
Add button Button used for saving the Adverse Event Details section. Also allows multiple entries to this section. Required

If you do not select the Add button to save the Adverse Event Details, when you Submit the page, you will get a warning that says "Data has been entered into the adverse event details add block. If you submit now you will lose those changes, are you sure you want to continue?" If you say Okay to this, it removes the info that you entered in the Adverse Event Details section.		 CRA Console edit / Subject Coordinator No
Tracking Details section
DSMC Reviewed The date the DSMC chair reviewed the SAE in real-time when it was sent via email to the SAE Notify mailbox. Not Required CRA Console edit / Subject Coordinator No
Notified DSMC The date the research staff notified the DSMC. Required

Oncology:
Notify saenotify@uwcarbone.wisc.edu of the SAE. This field must be updated for each follow-up SAE report submitted.

Non-oncology:
appropriate DSMC notification method based on protocol		 CRA Console edit / Subject Coordinator No
Notified Sponsor The date the research group notified the sponsor of the SAE, as defined by the protocol. Required CRA Console edit / Subject Coordinator No
Team Reviewed The date the research staff reviewed the SAE at the research group meeting. Not Required

Oncology: The UWCCC research groups enter this date for the study sites and the WON sites participating in their studies.		 CRA Console edit / Subject Coordinator No
SAE Identifiers section
Identifier Type Not Required CRA Console edit / Subject Coordinator No
Identifier Not Required CRA Console edit / Subject Coordinator No
Identifier Owner Not Required CRA Console edit / Subject Coordinator No
Event No. The unique number for the SAE that OnCore automatically assigns when a new SAE is submitted by selecting the Submit button. View Only N/A No
Supporting Documents Supporting documents are uploaded if applicable (AERS, MedWatch, hospital records). Not Required

Enter the Version Date and Description (type of document, refer to list above).		 CRA Console edit / Subject Coordinator No
Complete and Lock Do Not Use N/A No
SAE Details Report A report that displays the information entered in the SAE after closing the data entry screen. Required

To save the report, select "PDF" and select the "Subject SAE" hyperlink. A new window with the de-identified PDF report will open. Save the document to your computer as a PDF.		 CRA Console edit / Subject Coordinator No
SAE Report button Not Currently Used N/A No
"Create Follow Up" button (Follow Up No.) Select the "Create Follow Up" button when a follow up report is sent to the sponsor as instructed by the protocol. Not Required

OnCore assigns a unique number to the follow up report (with the initial SAE number referenced in parentheses).

Important Notes:
  • In the Event Narrative of the follow-up report, keep the detailed background information from the previous report(s) and add follow-up information in a separate paragraph. Format:
    • [DD/MM/YYYY] Update: [Detailed follow-up information describing the characteristics of the SAE as completely as possible to aid the DSMC in evaluating the relationship between the event and study intervention(s)].
  • The date that the sponsor and/or DSMC was notified of the follow-up information should also be updated accordingly.
 CRA Console edit / Subject Coordinator No


Keywords:
SAE AE serious adverse events
Doc ID:
102774
Owned by:
Ilsa G. in SMPH Research Applications
Created:
2020-06-03
Updated:
2026-09-04
Sites:
SMPH Research Applications