HOSMERIT
SOCRA CCRP EXAM PREP QUESTIONS
AND CORRECT ANSWERS LATEST GRADE A +
Chemistry, Manufacturing and Controls and non-clinical studiesrequire an _ to be filed. -
CORRECT ANSWER >>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 tosupport the _and of
investigational drugs (human and animal), biological products and medical devices. - CORRECT
ANSWER >>develop evidence / safety and effectiveness
US CFR GCP: Laws and regulations are intended to ensure integrity of clinical data and which
product approvals are basedand to - CORRECT ANSWER >>help protect the rights, safety
and welfare of human subjects.
CFR 21 Part 11 is in regard to_ - CORRECT ANSWER
>>Electronic records, electronic signatures
CFR 21 Part 50 is in regard to_ - CORRECT ANSWER
>>Informed Consent
CFR 21 Part 54 is in regard to- CORRECT ANSWER
>>Financial Disclosure
CFR 21 Part 56 is in regard to- CORRECT ANSWER
>>Institutional Review Boards (IRBs)
,CFR 21 Part 312 is in regard to - CORRECT ANSWER
>>Investigational New Drug Application (IND)
CFR 21 Part 314 is in regard to - CORRECT ANSWER
>>New Drug Application (NDA)
CFR 21 Part 812 is in regard to _ - CORRECT ANSWER
>>Investigational Device Exemption (IDE)
CFR 21 Part 814 is in regard to - CORRECT ANSWER
>>Premarket Approval of Medical Devices (PMAMD)
CFR 45 Part 46 is in regard to- CORRECT ANSWER
>>Federal Research
45 CFR 46 Part A Common Rule - CORRECT ANSWER >>HHS regulations for
PROTECTION OF HUMAN SUBJECTS inresearch
ICH E series covers: - CORRECT ANSWER >>EfficacyGuidelines
ICH E2A covers: - CORRECT ANSWER >>Clinical Safety DataManagement
ICH E3 covers: - CORRECT ANSWER >>Clinical StudyReporting
, ICH E6 covers: - CORRECT ANSWER >>Good Clinical Practice(GCP)
ICH E7 covers: - CORRECT ANSWER >>Geriatric Populations
ICH E8 covers: - CORRECT ANSWER >>GeneralConsiderations for Clinical Trials
ICH E9 covers: - CORRECT ANSWER >>Statistical Principles
ICH E11 covers: - CORRECT ANSWER >>Pediatric Populations
ICH Q series covers: - CORRECT ANSWER >>QualityGuidelines
ICH S series covers: - CORRECT ANSWER >>Safety Guidelines
ICH M series covers: - CORRECT ANSWER >>MultidisciplinaryGuidelines
ICH E6 GCP definition - CORRECT ANSWER >>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 - CORRECT ANSWER >>E6 GCP
guidance provides unified standard for the EU, Japan and the US to facilitate mutual acceptance
of clinical tata by regulatoryauthorities in those jurisdictions.
SOCRA CCRP EXAM PREP QUESTIONS
AND CORRECT ANSWERS LATEST GRADE A +
Chemistry, Manufacturing and Controls and non-clinical studiesrequire an _ to be filed. -
CORRECT ANSWER >>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 tosupport the _and of
investigational drugs (human and animal), biological products and medical devices. - CORRECT
ANSWER >>develop evidence / safety and effectiveness
US CFR GCP: Laws and regulations are intended to ensure integrity of clinical data and which
product approvals are basedand to - CORRECT ANSWER >>help protect the rights, safety
and welfare of human subjects.
CFR 21 Part 11 is in regard to_ - CORRECT ANSWER
>>Electronic records, electronic signatures
CFR 21 Part 50 is in regard to_ - CORRECT ANSWER
>>Informed Consent
CFR 21 Part 54 is in regard to- CORRECT ANSWER
>>Financial Disclosure
CFR 21 Part 56 is in regard to- CORRECT ANSWER
>>Institutional Review Boards (IRBs)
,CFR 21 Part 312 is in regard to - CORRECT ANSWER
>>Investigational New Drug Application (IND)
CFR 21 Part 314 is in regard to - CORRECT ANSWER
>>New Drug Application (NDA)
CFR 21 Part 812 is in regard to _ - CORRECT ANSWER
>>Investigational Device Exemption (IDE)
CFR 21 Part 814 is in regard to - CORRECT ANSWER
>>Premarket Approval of Medical Devices (PMAMD)
CFR 45 Part 46 is in regard to- CORRECT ANSWER
>>Federal Research
45 CFR 46 Part A Common Rule - CORRECT ANSWER >>HHS regulations for
PROTECTION OF HUMAN SUBJECTS inresearch
ICH E series covers: - CORRECT ANSWER >>EfficacyGuidelines
ICH E2A covers: - CORRECT ANSWER >>Clinical Safety DataManagement
ICH E3 covers: - CORRECT ANSWER >>Clinical StudyReporting
, ICH E6 covers: - CORRECT ANSWER >>Good Clinical Practice(GCP)
ICH E7 covers: - CORRECT ANSWER >>Geriatric Populations
ICH E8 covers: - CORRECT ANSWER >>GeneralConsiderations for Clinical Trials
ICH E9 covers: - CORRECT ANSWER >>Statistical Principles
ICH E11 covers: - CORRECT ANSWER >>Pediatric Populations
ICH Q series covers: - CORRECT ANSWER >>QualityGuidelines
ICH S series covers: - CORRECT ANSWER >>Safety Guidelines
ICH M series covers: - CORRECT ANSWER >>MultidisciplinaryGuidelines
ICH E6 GCP definition - CORRECT ANSWER >>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 - CORRECT ANSWER >>E6 GCP
guidance provides unified standard for the EU, Japan and the US to facilitate mutual acceptance
of clinical tata by regulatoryauthorities in those jurisdictions.
