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SOCRA CCRP EXAM PREP Questions and Correct Answer
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Elscores 8/19/2024 12:50:12 AMSOCRA CCRP EXAM PREP Questions
and Correct Answer
Chemistry, Manufacturing and Controls and non-clinical studies require an ______ to be
filed.
~: The NDA for a drug or biologic is filed when the sponsor considers there is sufficient info to
meet the regulatory requirement for approval.
FDA regulates scientific studies that are designed to ___ ___ to support the ___ and ____ of
investigational drugs (human and animal), biological products and medical devices.
~: develop evidence / safety and effectiveness
US CFR GCP: Laws and regulations are intended to ensure integrity of clinical data and
which product approvals are based and to ___
~: help protect the rights, safety and welfare of human subjects.
CFR 21 Part 11 is in regard to____
~: Electronic records, electronic signatures
CFR 21 Part 50 is in regard to ___
~: Informed Consent
CFR 21 Part 54 is in regard to___
~: Financial Disclosure
, Elscores 8/19/2024 12:50:12 AM
CFR 21 Part 56 is in regard to___
~: Institutional Review Boards (IRBs)
CFR 21 Part 312 is in regard to___
~: Investigational New Drug Application (IND)
CFR 21 Part 314 is in regard to___
~: New Drug Application (NDA)
CFR 21 Part 812 is in regard to___
~: Investigational Device Exemption (IDE)
CFR 21 Part 814 is in regard to___
~: Premarket Approval of Medical Devices (PMAMD)
CFR 45 Part 46 is in regard to___
~: Federal Research
45 CFR 46 Part A Common Rule
~: HHS regulations for PROTECTION OF HUMAN SUBJECTS in research
ICH E series covers:
~: Efficacy Guidelines
, Elscores 8/19/2024 12:50:12 AM
ICH E2A covers:
~: Clinical Safety Data Management
ICH E3 covers:
~: Clinical Study Reporting
ICH E6 covers:
~: Good Clinical Practice (GCP)
ICH E7 covers:
~: Geriatric Populations
ICH E8 covers:
~: General Considerations for Clinical Trials
ICH E9 covers:
~: Statistical Principles
ICH E11 covers:
~: Pediatric Populations
ICH Q series covers:
~: Quality Guidelines
, Elscores 8/19/2024 12:50:12 AM
ICH S series covers:
~: Safety Guidelines
ICH M series covers:
~: Multidisciplinary Guidelines
ICH E6 GCP definition
~: International Conference on Harmonization (ICH) Good Clinical Practice (GCP) E6(R2) is an
international ethical and scientific quality standard for designing, conducting, recording and
reporting trials that involve the participation of human subjects
ICH E6 GCP Countries
~: E6 GCP guidance provides unified standard for the EU, Japan and the US to facilitate mutual
acceptance of clinical tata by regulatory authorities in those jurisdictions.
Guidance developed with consideration of the current good clinical practices of the European
Union, Japan, and the United
States, as well as those of Australia, Canada, the Nordic countries, and the World Health
Organization.
ICH E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1)
~: ICH E6(R2) integrated addendum affects the full clinical trial cycle and research enterprise.
Focus is on increasing human subject protections and data integrity through better study design
and conduct. Most changes affect the sponsor. Origin from the Declaration of Helsinki.
ICH E6 (R2) GCP: Integrated Addendum to ICH E6 (R1) - Focus of Revisions
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