SOCRA CCRP EXAM PRE EXAM 150 QUESTIONS AND VERIFIED ANSWERS 2024
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SOCRA CCRP
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SOCRA CCRP
SOCRA CCRP EXAM PRE EXAM 150 QUESTIONS AND VERIFIED ANSWERS 2024
Chemistry, Manufacturing and Controls and non-clinical studies require an to be
filed. - ANSWERThe NDA for a drug or biologic is filed when the sponsor considers there is sufficient info to meet the regulatory requirement for app...
SOCRA CCRP EXAM PRE EXAM 150
QUESTIONS AND VERIFIED
ANSWERS 2024
Chemistry, Manufacturing and Controls and non-clinical studies require an to be
filed. - ANSWERThe 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. - ANSWERdevelop 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 - ANSWERhelp protect the rights, safety
and welfare of human subjects.
CFR 21 Part 11 is in regard to - ANSWERElectronic records, electronic signatures
CFR 21 Part 50 is in regard to - ANSWERInformed Consent
CFR 21 Part 54 is in regard to - ANSWERFinancial Disclosure
CFR 21 Part 56 is in regard to - ANSWERInstitutional Review Boards (IRBs)
CFR 21 Part 312 is in regard to - ANSWERInvestigational New Drug Application
(IND)
CFR 21 Part 314 is in regard to - ANSWERNew Drug Application (NDA)
CFR 21 Part 812 is in regard to - ANSWERInvestigational Device Exemption (IDE)
CFR 21 Part 814 is in regard to - ANSWERPremarket Approval of Medical Devices
(PMAMD)
CFR 45 Part 46 is in regard to - ANSWERFederal Research
45 CFR 46 Part A Common Rule - ANSWERHHS regulations for PROTECTION OF
HUMAN SUBJECTS in research
, ICH E series covers: - ANSWEREfficacy Guidelines
ICH E2A covers: - ANSWERClinical Safety Data Management
ICH E3 covers: - ANSWERClinical Study Reporting
ICH E6 covers: - ANSWERGood Clinical Practice (GCP)
ICH E7 covers: - ANSWERGeriatric Populations
ICH E8 covers: - ANSWERGeneral Considerations for Clinical Trials
ICH E9 covers: - ANSWERStatistical Principles
ICH E11 covers: - ANSWERPediatric Populations
ICH Q series covers: - ANSWERQuality Guidelines
ICH S series covers: - ANSWERSafety Guidelines
ICH M series covers: - ANSWERMultidisciplinary Guidelines
ICH E6 GCP definition - ANSWERInternational 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 - ANSWERE6 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) -
ANSWERICH 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 -
ANSWERUsing a risk management approach in designing studies. Promoting the use
of risk-based and centralized monitoring in managing studies. Addressing the reporting
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