What kind of adverse events must be reported within specified time frames to Health Canada and the FDA?

A serious adverse event (experience) or reaction is

The term "life-threatening" in the definition of "serious" refers to

Important medical events that may not result in death, be life-threatening, or require hospitlization may be considered a serious adverse drug experience when

An unexpected adverse event is defined as

Unexpected (as used in the definition of SUSAR's)

An event is said to be associated with the use of the product when there exists

What are the categories of causality?

When an AE occurs that meets the criteria for an SAE, and it is also both unexpected and associated with the IP, HC and FDA requires investigators to

Under CTA or IND submissions: Will the sponsor require expedited reporting of all SAEs from investigators, independent of the investigator's assessment of causality?

Under CTA or IND submissions: Do HC or FDA directives/guidances specify how to resolve differences b/w the investigator and sponsor assessments of causality?

What is the industry standard for reporting of SAEs by the site to the sponsor?

Where are the SAE reporting requirements described?

Expedited reporting to regulatory agencies is not required for events that are either:

Since all SAEs are still adverse events, they must be recorded on

What is expanded reporting of SAEs?

Who provides the forms for SAE reporting?

What kind of information is gathered regarding an SAE?

What demographic data and patient details are to be included in the SAE Reports?

What Product information needs to be included in SAE reports?

What information regarding "Other treatments" needs to be included in SAE reports?

What Details of the suspected adverse event need to be included in the SAE reports?

What information regarding the Treatment of the event, needs to be included in SAE Reports?

What information regarding the Outcome needs to be included in SAE Reports?

What Details of the person submitting the report need to be included in the SAE Report?

What Administrative and sponsor information needs to be included in the SAE report?

What are SUSARs?

What are IND Safety Reports?

Once a sponsor files a SUSAR in Canada or an IND Safety Report with the FDA, what notifications need to be sent out and to whom?

Once the sponsor notifies the investigator about a SUSAR, what does the investigator need to do?

Unexpected SAEs associated with the drug but not fatal or life-threatening must be reported by the Sponsor to the regulatories within

Unexpected SAEs associated with the drug but not fatal or life-threatening must be reported by the Sponsor to investigators within

Unexpected SAEs associated with the drug and fatal or life-threatening must be reported by the Sponsor to the regulatories within

Unexpected SAEs associated with the drug and fatal or life-threatening must be reported by the Sponsor to the investigators within

When is an event considered to be an Adverse Drug Reaction?

When can new ADRs be discovered?

Does the FDA define ADRs?

Where are ADRs defined?

Regarding marketed medicinal products, a definition of an adverse drug reaction in the post-marketing setting is found in

Why is the term side effect not used any more - and should not be regarded as synonymous with adverse event or adverse reaction?

Name some of the programs established to gather AE information on marketed products.

Do sponsors need to submit periodic summary reports of AEs to the regulatories?

What is a narrative and where would you find more information about how to write one?

Comparison of site versus sponsor assessment of SAE.

DCF

FWA

OHRP

Investigator assures Subject Safety and Study Integrity by

At the site, if immediate/emergency intervention is needed for an AE then:

At the site, if no immediate/emergency intervention is needed for the AE then:

Comparison of clinical role versus research role

What action may be taken/may happen with study product/study after an adverse event?

DMC

RSC

What is the study team? What is the RSC?

For information on Safety refer to

MedDRA

MSSO

What is MedDRA?

What is a thesaurus?

SOC

HLGT

MedDRA is managed by

Who holds the intellectual property rights (ownership) of MedDRA?

Who acts as the MSSO?

What is the MedDRA pricing for regulators and the industry?

The Japanese counterpart for MSSO is called

Why, how and by whom is MedDRA updated?

How many versions of MedDRA are released in a year, how often and by whom?

Scope of MedDRA - What is included/in?

Scope of MedDRA - What is excluded/out?

For information on problems with coding in MedDRA and use by regulatory agencies

Are death, hospitalization and disability considered to be adverse events?

What is soft coding?

Why is accuracy in coding important?

Why is inaccurate AE term submission by sites risky?

MedDRA was developed by

What code is assigned to each MedDRA term?

Where is MedDRA applied? Give examples.

AE term selection by site suggestions and sources of error?

What are study agents in adverse event reporting and where will they be specified?

What is the protocol specified reporting period?

After the protocol-defined AE reporting period, is anything reported by the site to the sponsor?

What are clinically significant anomalies (congenital anomalies/birth defects) and how does one qualify them for reporting purposes?

List some examples of important medical events that may be considered as SAEs.

AEs are assessed for

Who's responsible for the AE assessment at the site?

How would you look for a primary adverse event in a subject during the study?

How many AEs may be included in one report?

Is death in and of itself an AE term?

When the term is "Death Unknown cause" then relationship cannot be

Can death be an expected outcome?

How do you determine whether primary AE meets the criteria for an SAE?

What is seriousness of an adverse event based upon?

Is severity a factor in determining reportability?

How is severity of an adverse event determined?

Grading abnormal laboratory values associated with a clinical AE:
– When lab values fall between two grades choose

Potentially life-threatening would be categorized as what grade of severity?

Event led to hospitalization, but graded as “Grade 1” or “Grade 2”. Grade the SAE, and not the

When a SAE is assessed as “not related” to study agent(s), does an explanation for the SAE need to be given?

When might the relationship
assessment of any AE be reviewed again?

When the study agent is a fixed dose combination agent, an assessment of attribution (for SAE) will be made for

Could expectedness be based on what might be anticipated from the pharmacological properties of the
study agent?

For the SAE, reporting category, who determines expectedness?

For SUSARs, reporting category of expectedness is determined by whom?

What kind of adverse events require expedited reporting?

For expedited reports, queries sent by the sponsor to the site need a response from the site within

Who is a medical officer?

Once the expedited report is sent by the site to the sponsor, who determines as to whether the expedited report meets regulatory safety reporting requirements?

SAE Reporting Category flowchart

Do you need to report an SAE occurring before exposure to a study agent?

What kind of AEs are reportable on new/initial reports?

What are the criteria used to determine reporting days?

Who reviews and verifies the completed report for accuracy and completeness at the site?

In the rare event that site physician(s) are not available for
signature of the expedited reports

When presented with a case or data that need to be evaluated for expediting reporting, how would you proceed?

What are the most important objectives when studying a case for adverse event reporting?

What initial questions do you need to ask to fulfill the objectives for adverse event reporting?

To review a case and assess causality:

Questions to be asked as a follow up for/to causality cases?

ALCOA

I