This is a starting point requirements capability statement for the AdverseEvent Clinical Research Profile. It is expected that specific use cases will lead to further specification in derived IGs.

An example profile of AdverseEvent for Research reporting.

Indicates if the subject discontinued the study due to the adverse event.

The contributing factors suspected to have increased the probability or severity of the adverse event.

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.

Comments made about the adverse event by the performer, subject or other participants.

Indicates who or what participated in the adverse event and how they were involved.

Communicates Research Subject related metadata.

The date the adverse event was resolved.

Information about the condition that occurred as a result of the adverse event.

TBD - Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity. For cancer related trials, severity is represented as a grade.

The current workflow state of the adverse event or potential adverse event. This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient’s condition.

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject’s medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

Describes the entity that is suspected to have caused the adverse event.

Value set for stating if a suspected entity is Not Related, Unlikely Related, Possibly Related, or Related to the cause of the adverse event. Using NCI codes. The values originate with ICH. For information on ICH see https://admin.ich.org/sites/default/files/inline-files/OID_Information_Paper_1.pdf from the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) document ICH E2B(R3), the Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification, and ICH M8, the Electronic Common Technical Document

This value set includes codes that describe the contributing factors suspected to have increased the probability or severity of the adverse event.

This value set includes codes that describe the ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.

This value set includes codes that describe the type of outcome from the adverse event as typically used in reporting for Clinical Research, post-market surveillance (e.g. Medwatch forms). NCI codes used here This list originates from the ICH E2B R3 (https://database.ich.org/sites/default/files/E2D_Guideline.pdf), specifically CDISC CL.C66768.OUT. For information on ICH see https://admin.ich.org/sites/default/files/inline-files/OID_Information_Paper_1.pdf from the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) document ICH E2B(R3), the Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification, and ICH M8, the Electronic Common Technical Document.

This value set includes codes that describe the type of involvement of the actor in the adverse event.

Action criteria usually associated with serious events that pose a threat to a patient’s life or functioning. Adverse Events criteria to expand on the seriousness of the adverse event. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch). The adverse event seriousness criteria value set is based on the ICH E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting guidance (https://database.ich.org/sites/default/files/E2D_Guideline.pdf). For information on ICH see https://admin.ich.org/sites/default/files/inline-files/OID_Information_Paper_1.pdf from the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) document ICH E2B(R3), the Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification, and ICH M8, the Electronic Common Technical Document

This value set includes codes that describe the ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.

This value set includes codes that indicate severity of the adverse event or grade.

Codes identifying the lifecycle stage of an adverse event.

This value set includes codes that describe the supporting information relevant to the event.

This value set includes codes that describe the adverse event or incident that occurred or was averted.

Hierarchical Code System for codes that indicate severity of the adverse event or grade.

Additional codes found on https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event#:~:text=Required%20Intervention%20to%20Prevent%20Permanent%20Impairment%20or%20Damage%20(Devices),use%20of%20a%20medical%20product. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch).

example

Use case 6B - Patient report of Adverse Event, example of data that would be on MedWatch form as reported by Patient

Grade 1 ALT

Grade 3 ALT

ALT back to grade 1 and resolved

Grade 1 Nausea/vomiting // both are AEs, which to use or make them separate?

Adverse event from procedure, not study drug

Serious Adverse Event Research Study Medication Example

Non-Serious Adverse Event Research Study Medication Example

Use Case 1 - SAE Patient SCHJO on Research Study XYZ, Study ID XYZ-123, Subject number XYZ-123-002.

Use case 7. Clinical Trial subject number 5. Acute Hepatic Failure.

The fifth subject enrolled in the trial develops severe hepatic failure complicated by encephalopathy one month after starting the study. The study sponsors determined that is an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was unexpected in severity; possibly related to participation in the research; and serious.

The fifth subject enrolled in the trial develops severe hepatic failure complicated by encephalopathy one month after starting the study. The study sponsors determined that is an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was unexpected in severity; possibly related to participation in the research; and serious.

Patient Janet, 64-year old woman on clinical trial

Breast Cancer clinical trial example

Janet weight observation

Janet Blood Pressure Observation

Self reported Janet Tylenol PM med

Self reported Janet allergy med

Self reported Janet pill for water retention med not known

Study medication info Medication Administration for bresentrik

Study medication, bresentrik

Study medication info Medication Request for bresentrik

Medication administration example

Study medication info Medication Request for clinical trial medication ABC - discontinued

Study medication info Medication Request for clinical trial medication 0301 - discontinued

Use case 6B - patient reported AE problem

Compass Trial example patient Kaitlyn

Example RN practitioner

Example Oncologist

Example showing clinial trial medication Kadcyla

Example showing clinial trial medication Tucatinib

Example showing clinial trial medication adminstration Kadcyla

Example showing clinial trial medication adminstration Tucatinib

Alliance COMPASS Protocol A011801

Alliance COMPASS trial research subject

Example reduced dose of clinial trial medication adminstration Kadcyla

Example reduced does of clinial trial medication adminstration Tucatinib

Example for medication Zofran

Gastrointestinal (GI) bleed

Use Case 15 Research Study XYZ

Example study medication ABC

Example for clinial trial medication ABC

Example Procedure Upper Endoscopy

Use Case 16 Research Study DISNEY

Example study medication MMD

Example for clinial trial medication MMD

Example medication for Tylenol

Example of Tylenol

Use Case 17 Research Study ACME

Clinical trial ACME research subject

Clinical trial ACME protocol-prescribed procedure of a Lung CT Scan, with contrast dye

Example for clinial trial medication WBY

Example contrast dye medication

Example medication administration for contrast dye

Example medication for hives

Example medication administration for hives

Example clinical trial medication WBY

Use Case 16 Patient MOUMIC on Research Study DISNEY

Patient enrolled in ACME study, taking Study Medication WBY 10 mg orally daily every morning for moderate asthma