SOCRA CCRP EXAM PREP (ACTUAL EXAM)
QUESTIONS WITH VERY ELABORATED
ANSWERS CORRECTRY WELL ORGANIZED
LATEST 2024 – 2025 ALREADY GRADED A+
A _____________ ________ __________ is defined as any experience that
suggests a significant hazard, contraindication, side effect or precaution.
Has one or more of the following outcomes: Fatal Life-threatening Requires or
prolongs inpatient hospitalization Results in persistent or significant disability or
incapacity A congenital anomaly. - ANSWERS-Serious adverse event (SAE)
A _______ __________ _________is an AE for which a causal relationship to the
investigational product is at least a reasonable possibility, i.e. -a causal
relationship can not be ruled out. - ANSWERS-Suspected adverse reaction
An ___________ ______ _______ ___ ________ _______ is one that is not
identified in nature, severity or frequency in the current Investigator's Brochure.
Nature: the event has not been reported previously
Severity: prior reports were of mild intensity, but the current event is of moderate
or severe intensity
,Frequency: In the Investigator's Brochure, frequency was 1%, but has increased to
5% in current study - ANSWERS-Unexpected adverse event or adverse reaction
A _____ ___ ____________ ____ ____________is an adverse reaction that is both
serious and unexpected. - ANSWERS-Suspected and unexpected adverse reaction
(SUSAR)
Who notifies the FDA of any adverse events associated with the use of a drug that
are both serious and unexpected? - ANSWERS-Sponsor
When must the FDA be notified of a SUSAR? - ANSWERS-15 CALENDAR days after
Sponsor's initial notification.
CFR 21 Part 11 is in regard to____ - ANSWERS-Electronic records, electronic
signatures
CFR 21 Part 50 is in regard to ___ - ANSWERS-Informed Consent
CFR 21 Part 54 is in regard to___ - ANSWERS-Financial Disclosure
CFR 21 Part 56 is in regard to___ - ANSWERS-Institutional Review Boards (IRBs)
CFR 21 Part 312 is in regard to___ - ANSWERS-Investigational New Drug
Application (IND)
, CFR 21 Part 314 is in regard to___ - ANSWERS-New Drug Application (NDA)
CFR 21 Part 812 is in regard to___ - ANSWERS-Investigational Device Exemption
(IDE)
CFR 21 Part 814 is in regard to___ - ANSWERS-Premarket Approval of Medical
Devices (PMAMD)
CFR 45 Part 46 is in regard to___ - ANSWERS-Federal Research
45 CFR 46 Part A Common Rule - ANSWERS-HHS regulations for PROTECTION OF
HUMAN SUBJECTS in research
ICH E series covers: - ANSWERS-Efficacy Guidelines
ICH E2A covers: - ANSWERS-Clinical Safety Data Management
ICH E3 covers: - ANSWERS-Clinical Study Reporting
ICH E6 covers: - ANSWERS-Good Clinical Practice (GCP)
ICH E7 covers: - ANSWERS-Geriatric Populations
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