ICH E2 Clinical Safety Data Management Flashcards
Where can risk reduction activities be incorporated?
Risk reduction activities may be incorporated in protocol design and implementation, monitoring plans, agreements between parties defining roles and responsibilities, systematic safeguards to ensure adherence to standard operating procedures, and training in processes and procedures.
Describe Serious, Expected ADRs, Expedited Reporting
No expedited reporting of reactions which are serious but expected
What is the standards for Serious Events not related to study product, Expedited Reporting?
No Expedited reporting
What is the standards for Non-Serious AEs, Expedited Reporting?
No Expedited reporting
T/F All cases judged by either the reporting health care professional or the sponsor as having a reasonable suspected causal relationship to the medicinal product qualify as ADRs
True
T/F There are situations in addition to single case reports of “serious” adverse events or reactions that may necessitate rapid communication to regulatory authorities
True
What are some situations in addition to single case reports of “serious” adverse events or reactions that may necessitate rapid communication to regulatory authorities?
- For an “expected,” serious ADR, an increase in the rate of occurrence which is judged to be clinically important.
- A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease
- A major safety finding from a newly completed animal study (such as carcinogenicity)
When should Fatal or Life-Threatening Unexpected ADRs be reported?
Regulatory agencies should be notified as soon as possible but no later than 7 calendar days after first knowledge by the sponsor, followed by as complete a report as possible within 8 additional calendar days.
When should All Other Serious, Unexpected ADRs be reported?
Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible but no later than 15 calendar days after first knowledge by the sponsor
Whose responsibility is it to decide whether active comparator drug reactions should be reported to the other manufacturer and/or directly to appropriate regulatory agencies?
It is the sponsor’s responsibility to decide whether active comparator drug reactions should be reported to the other manufacturer and/or directly to appropriate regulatory agencies
T/F ADR that qualifies for expedited reporting with one presentation of a product does not need to be reported or referenced to regulatory filings across other product presentations and uses
False. ADR that qualifies for expedited reporting with one presentation of a product (e.g., a dosage form, formulation, delivery system) or product use (e.g., for an indication or population), should be reported or referenced to regulatory filings across other product presentations and uses.
Do serious adverse events that occurred after the patient had completed a clinical study which are possibly be reported by an investigator to the sponsor need expedited reporting?
Serious adverse events that occurred after the patient had completed a clinical study (including any protocol-required post-treatment follow-up) will possibly be reported by an investigator to the sponsor. Such cases should be regarded for expedited reporting purposes as though they were study reports.
What term is used to describe intensity of a specific event such as mild, moderate, severe etc. ?
Severity
What term is based on the patient/event outcome or action criteria usually associated with events that pose a threat to a patient’s life or functioning?
Serious
Which documents or circumstances are utilized to determine whether an AE is expected?
1) Investigator’s brochure
2) Reports which add significant information on specificity or severity of an already known and documented ADR - an event more specific or more severe than is described in the IB
