SOCRA - Society of Clinical Research Associates Adverse Event Safety Reporting Questions and Answers 2 — Questions and Answers
Question 1: What is the timeframe for reporting unexpected fatal or life-threatening suspected adverse reactions to the FDA?
- 30 calendar days
- 7 calendar days (Correct answer)
- 15 calendar days
- 90 calendar days
Correct answer: 7 calendar days
Per 21 CFR 312.32, sponsors must report these within 7 calendar days.
FDA regulation 21 CFR 312.32(c)(2) requires notification within 7 calendar days. A follow-up report is due within 15 days. For other serious and unexpected reactions, the initial report is due within 15 calendar days.
Question 2: What is the difference between an adverse event (AE) and an adverse drug reaction (ADR)?
- No difference
- An AE is any untoward occurrence regardless of causality; an ADR implies a causal relationship (Correct answer)
- An ADR is less serious
- An AE only occurs during treatment
Correct answer: An AE is any untoward occurrence regardless of causality; an ADR implies a causal relationship
An AE is any untoward medical occurrence regardless of causal relationship; an ADR implies at least a reasonable possibility of causal relationship.
Per ICH E2A, an AE does not necessarily have a causal relationship with treatment. An ADR implies causality. During trials, all AEs are collected but only those with reasonable causal relationship are classified as ADRs.
Question 3: What information must be included in an expedited safety report?
- Only the participant's name
- Patient identification, event description, suspect drug information, reporter information, and causality assessment (Correct answer)
- Just the MedWatch form number
- Only drug name and batch number
Correct answer: Patient identification, event description, suspect drug information, reporter information, and causality assessment
Reports must include patient identification, detailed event description, suspect drug information, reporter details, and causality assessment.
An expedited IND safety report (MedWatch 3500A) must include patient demographics, detailed AE description, suspect investigational product information, relevant medical history, reporter's causality assessment, and corrective actions taken.
Question 4: What is a SUSAR and why is it significant?
- Standard Unrelated Safety Assessment Report
- A Suspected Unexpected Serious Adverse Reaction requiring expedited reporting (Correct answer)
- Safety Update Summary for Annual Review
- Supplemental Urgent Safety Alert Request
Correct answer: A Suspected Unexpected Serious Adverse Reaction requiring expedited reporting
A SUSAR is a serious adverse reaction that is suspected, unexpected, and requires expedited reporting.
A SUSAR meets three criteria: suspected causal relationship, serious, and unexpected (not in reference safety information). SUSARs require expedited reporting (7 days fatal/life-threatening, 15 days others) and communication to investigators and ethics committees.
Question 5: What is the role of pharmacovigilance during a clinical trial?
- Manage the trial budget
- Collect, assess, and report safety data throughout the trial lifecycle (Correct answer)
- Recruit participants
- Manufacture the investigational product
Correct answer: Collect, assess, and report safety data throughout the trial lifecycle
Pharmacovigilance is responsible for systematic collection, detection, assessment, monitoring, and prevention of adverse effects.
PV processes AE/SAE reports, performs causality assessment, submits expedited reports, prepares aggregate reports (DSURs/PSURs), maintains the safety database, updates the IB safety section, and communicates safety information to investigators.
Question 6: What is a Development Safety Update Report (DSUR)?
- A daily safety summary
- An annual report providing comprehensive safety analysis during drug development (Correct answer)
- A report only when SAEs occur
- A post-marketing report
Correct answer: An annual report providing comprehensive safety analysis during drug development
A DSUR is an annual report providing comprehensive safety analysis of information collected during the reporting period.
The DSUR (ICH E2F) covers a 12-month period and includes a review of all safety data, cumulative SAE summary, analysis of safety topics, evaluation of benefit-risk profile, and proposed changes to the IB or protocol.
SOCRA - Society of Clinical Research Associates Adverse Event Safety Reporting Questions and Answers 2
What is the timeframe for reporting unexpected fatal or life-threatening suspected adverse reactions to the FDA?