Fda form 482 - Study guides, Class notes & Summaries

CCRP SOCRA Exam Graded A+ FDA Part 11 - ANSelectronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - ANSFood and Drugs, and ICF FDA Part 56 - ANSIRBs FDA Part 312 - ANSinvestigational new drug application FDA Part 812 - ANSinvestigational drug exemption FDA Form 482 - ANSNotice of inspection FDA Form 483 - ANSLetter of investigational observations/citation of noncompliance that specifies how lon...

When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) How man...

SOCRA Exam Questions With 100% Correct Answers When isn't an IND application needed? - answerIND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) - answer-FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Addi...

SOCRA CCRP Exam Review Questions and answers, rated A+ FDA Part 11 - -electronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - -Food and Drugs, and ICF FDA Part 56 - -IRBs FDA Part 312 - -investigational new drug application FDA Part 812 - -investigational drug exemption FDA Form 482 - -Notice of inspection FDA Form 483 - -Letter of investigational observations/citation of noncompliance that ...

When isn't an IND application needed? - IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) - -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) ...

SOCRA CCRP 2023 Exam Questions and Answers All Correct FDA Part 11 - Answer-electronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - Answer-Food and Drugs, and ICF FDA Part 56 - Answer-IRBs FDA Part 312 - Answer-investigational new drug application FDA Part 812 - Answer-investigational drug exemption FDA Form 482 - Answer-Notice of inspection FDA Form 483 - Answer-Letter of investiga...

CCRC Exam Questions And Answers Protocols - ANS 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance 12) ethics 13) data handling and record keeping 14) financing and insurance 15) publication policy 16) supplements Phase 1 - ANS -intro of new drug/inve...

Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed ...

SoCRA Exam Review Questions and answers, rated A+ 45 CFR 46 Subpart A - -"Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B - -Additional protections for pregnant women, human fetuses, and neonates (46.200) 45...

Certified Clinical Research Professional (CCRP) Exam 100% Pass When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional informa...