What does ind - Study guides, Class notes & Summaries

NR 546 Midterm Exam 2023/2024 Questions AND Answers Update A+ What should the PMHNP consider when prescribing chemical restraints? - Answer-- allergy status -prior med hx for adverse drug reactions r/t the meds ordered in the chemical restraint -state regulations regarding chemical restrains must be reviewed Are the PMHNP and other staff liable if the client has an allergic reaction or adverse side effects to the drugs used for chemical restraint? - Answer-No. The client has been court-...

Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension - correct answer SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... - correct answer Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? - correct answer 1) Seizure of drugs 2) Crimin...

When isn't an IND application needed? - ANSWER-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) - 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 -Additional information (drug dependence and abuse...

DASA Mock Exam 2023 Rated A+ In a traditional setup, what should an organization do to avoid problems that occur in production? A. Encourage group discussions between Development and QA teams in the earlier phases of product development. B. Encourage sharing the required information between the Development and Operations teams. C. Automate feedback from customers on usability issues. D. Develop knowledge articles for unknown issues. B Which way can help you dissolve the Wall of Confusio...

Certified Clinical Research Professional (CCRP) /SOCRA Exam 2024 When isn't an IND application needed? - CORRECT ANSWER-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) - CORRECT 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 ...

CITI GCP Training Questions and Answers Graded A+ ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate ...

SOCRA Exam Review Questions and answers, rated A+ 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 -Addition...

NMTCB Review Latest Update Graded A+ NRC Nuclear Regulatory Commission DOT Department of Transportation Type A Packaging Adequate for normal transport Type B Packaging Used for large quantities of radioactivity What type of packaging is used for routine transport of radio pharmaceuticals? Type A Categories for labeling Type A packages Measured dose rate, package surface, 1 m from the surface TI Transport Index Transport index Dose rate measured at 1 m from the surface DOT 1 (white) -No m...

SOCRA Exam Review Questions and answers, Verified/ 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 312.23) - --Form 1571- cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research- literature review -Additional information (drug depende...

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...