ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Flashcards
The term “side effect” should be regarded as synonymous with adverse event or adverse reaction.
true
false
false
“It is recommended that the term “side effect” no longer be used and particularly should not be regarded as synonymous with adverse event or adverse reaction.”
II(A)(2)
Seriousness (not severity) serves as a guide for defining regulatory reporting obligations.
true
false
true
The terms “serious” and “sever” are not synonymous.
II(B)
Adverse drug reactions are categorized as “unexpected” or “expected” from the perspective of:
a) previously observed reactions
b) what might be anticipated from the pharmacological properties of a medicinal product
c) a and b)
a) previously observed reactions
II(C)
Until source documents are amended, expedited reporting is required for additional occurrences of the reaction.
true
false
true
II(C)
An event more specific or more severe than described in the Investigator’s Brochure would be considered “unexpected.”
true
false
true
II(C)(2)
Standards for Expedited Reporting
What should be reported?
a) non-serious adverse reactions, whether expected or not
b) reactions which are serious but expected
c) serious events from clinical investigations that are considered not related to study product, whether expected or not
d) all adverse drug reactions that are both serious and unexpected
d) all adverse drug reactions that are both serious and unexpected
III(A)(1)
Standards for Expedited Reporting
What should be reported?
a) an increase in the rate of occurrence in expected, serious ADR judged to be clinically important
b) significant hazard to patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease
c) major safety finding from a newly completed animal study (such as carcinogenicity)
d) a and c only
a, b, and c
III(A)(2)
Standards for Expedited Reporting
What is the reporting time frame for fatal or life-threatening unexpected ADRs by the sponsor?
a) as soon as possible but no later than 5 calendar days
b) as soon as possible but no later than 7 calendar days
c) as soon as possible but no later than 10 calendar days
d) as soon as possible but no later than 15 calendar days
b) as soon as possible but no later than 7 calendar days
III(B)(1)
…followed by as complete a report as possible within 8 additional calendar days.
Standards for Expedited Reporting
What is the reporting time frame for serious, unexpected reactions (ADRs) that are not fatal or life-threatening?
a) as soon as possible but no later than 5 calendar days
b) as soon as possible but no later than 7 calendar days
c) as soon as possible but no later than 10 calendar days
d) as soon as possible but no later than 15 calendar days
d) as soon as possible but no later than 15 calendar days
III(B)(2)
What form should be used to report expedited adverse events?
a) form FDA 3500
b) form FDA 3500A
c) CIOMS-I form
d) form FDA 1639
c) CIOMS-I form
III(C)
The CIOMS-I form has been a widely accepted standard for expedited adverse event reporting. However, no matter what the form or format used, it is important that certain basic information/data elements, when available, be included with the expedited report, whether in a tablular or narrative presentation.
http://www.cioms.ch/index.php/cioms-form-i
Guide to Clinical Research
p 1018
form FDA 1639 (refer to 21 CFR 314.80)
It is the ____________ responsibility to decide whether active comparator drug reactions should be reported to the other manufacturer and/or directly to appropriate regulatory agencies.
a) FDA’s
b) investigator’s
c) IRB’s
d) monitor’s
e) sponsor’s
e) sponsor’s
III(E)(1)
It is recommended that any adverse drug reactions that qualify for expedited reporting observed with one product dosage form or use be cross referenced to regulatory records for all other dosage forms and uses for that product.
true
false
true
III(E)(2)
In collecting adverse event data, investigators should generally report syndromes (e.g., congestive heart failure) rather than individual clinical signs (e.g., dyspnea, rales, cyanosis).
true
false
true
Guide to Clinical Research
p 197
The investigator-sponsor is to notify the FDA by telephone of any unexpected, fatal or life-threatening experience associated with the use of a drug in clinical studies conducted under the IND, within ____ calendar days after receiving the information.
a) 5
b) 7
c) 10
d) 15
b) 7
Protecting Study Volunteers in Research
p 73
Data from animal studies are also reportable as IND Safety Reports if any serious adverse drug experience is observed that suggests a significant risk for human subjects, including any finding of mutagenicity, teratogenicity or carcinogenicity.
true
false
true
Protecting Study Volunteers in Research
