CITI Training 134 Questions With Complete Solutions Latest Updated 2024 (GRADED A+)

CITI Training 134 Questions With Complete Solutions Latest Updated 2024 (GRADED A+) What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investigators conducting clinical trials under the IND. Correct Answer: Form FDA 1572 What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases (human trials). *30 day process. What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV marketing phase. How long does the NDA submission take? Correct Answer: 6 months - 2 years. What is determined for a drug in the preclinical phase Correct Answer: Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy warranting additional studying. How long does FDA have to review IND submission? Correct Answer: 30 days How long is the clinical development phase (Phase 1-III) in process for IND? Correct Answer: 6- 7 years. Determine the trial phase: - Assess toxicity - Determine drug's PK and PD profiles CITI Training 134 Questions With Complete Solutions Latest Update Score A+ - Determine doses resulting in sufficient biological level of drug Correct Answer: Phase I Determine the trial phase: - Determine drug's effectiveness (primary goal) - Determine long-term drug safety - Confirm findings Correct Answer: Phase III Determine the trial phase: - Determine drug's short-term risk (safety) (primary goal) - Examine preliminary effectiveness of drug Correct Answer: Phase II Determine the trial phase from the subject population: Controlled studies enrolling limited numbers of patients Correct Answer: Phase II Determine the trial phase from the subject population: Controlled and uncontrolled studies (but typically placebo-controlled and double-blinded) enrolling larger patient numbers. Correct Answer: Phase III Determine the trial phase from the subject population: Normal healthy volunteers unless toxicity prevents exposure (e.g, cancer drugs). In this, case patients with end-stage disease might be enrolled. Correct Answer: Phase I If an IND application is submitted and the FDA has not contacted the physician within 30 days after acknowledging receipt, can the trial start? Correct Answer: Yes, one of two conditions must be met. 1. 30 days elapsed since FDA received IND application and no hold as been placed. 2. Correspondence has ben received from FDA allowing the trial to start. What must be provided to investigators before they beginning conducting trials at their site? Correct Answer: Protocol and Investigator's Brochure What regulation must a PI comply with in order to use an edc system for a clinical trial? Correct Answer: 21 CFR Part 11 21 CFR 56.115(b) Correct Answer: 21 CFR 312.57 Correct Answer: 21 CFR 312.62 Correct Answer: 21 CFR 812.140 Correct Answer: What happened because of the concern and confusion regarding interpretation of Part 11in 2003. Correct Answer: FDA withdrew all the guidance documents related to Part 11, while reexamining. They then issued: Guidance for Industry: Part 11, Electronic Records; Electronic SignaturesScope and Application (2003) and Guidance for Industry: Computerized Systems Used in Clinical Investigations (2007). ** The 2007 guidance "supplements the 2003 guidance" Development of most new drugs from discovery to marketing approval usually takes: Correct Answer: 9 years or more The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 patients in each arm. Which of the following best describes the clinical phase of this study? Correct Answer: Phase 2 Adults with more than a 12-month history of migraines were assigned randomly in a doubleblinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study? Correct Answer: Phase 3 Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? Correct Answer: Preclinical Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? Correct Answer: Phase 1 For a Phase 1 new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? Correct Answer: Preclinical data What is ICH's more specific name? Correct Answer: International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use. what is the goal of the ICH? Correct Answer: to minimize redundant research. and standardize technical guidelines and requirements. Define the term: an individual, or judicial or other body, authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research Correct Answer: Legally Authorized Representative (LAR) an unplanned excursion from the requirements of the protocol that is not implemented or intended as a systematic change. Correct Answer: Protocol Deviation (or Violation) What are the 6 regulatory and pharmaceutical industry groups that have representatives working for ICH? Correct Answer: -European Commission (EC) -European Federation of -Pharmaceutical Industries' Association (EFPIA) -Ministry of Health, Labor, and Welfare, Japan (MHLW) - Japan Pharmaceutical Manufacturers Association (JPMA) - US Food and Drug Administration (FDA) - Pharmaceutical Research and Manufacturing of America (PhRMA) How do the World Health Organization (WHO) and the European Free Trade Association (EFTA) [represented by Swissmedic, and Health Canada participate with ICH? Correct Answer: As observers. How is the ICH governed? Correct Answer: a Steering Committee Who supports the ICH? Correct Answer: the ICH Secretariat Who provides the ICH secretariat? Correct Answer: The International Federation of Pharmaceutical Manufacturers Association (IFPMA) How many seats on the Committee does each of the 6 working groups of ICH have? Correct Answer: 2 who nominates other nonvoting participants to attend ICH steering Committee meetings? Correct Answer: The observer groups (WHO, Health Canada, and EFTA) Is the ICH GCP regulation or guideline? Correct Answer: Depends, several countries adopted it as law, but the U.S FDA adopted it only as guidance. (Federal Register, Vol. 62, MAY 9, 1997) What are the four main categories covered by ICH guidelines? Correct Answer: Q: Quality topics (chemical and pharmaceutical assurance) S: Safety topics: in vitro and in vivo preclinical research E: Efficacy topics: relating to research in human subjects M: Multidisciplinary topics: those that do not fit uniquely into one of the above categories. (QSEM) What are the expert working groups responsible for? Correct Answer: developing specific guidelines. * The ICH then provides an efficient process and format to standardize the new requirements across agencies and countries. ICH E6 guideline pertains specifically to what Correct Answer: the conduct of clinical research to support marketing applications for drugs. Provides a unified standard for designing, conducting, recording, and reporting research involving human subjects. Correct Answer: ICH E6 guideline for good clinical practice. What are the two important goals of the ICH E6 standard? Correct Answer: To assure that 1: The rights, well-being, and confidentiality of trial subjects are protected. 2: Trial data are credible. Where do the ethical principles followed by ICH GCP guidelines originate from? Correct Answer: the Declaration of Helsinki What ethical principles stem from the Declaration of Helsinki? Correct Answer: in notes.... If planning to market drugs outside the US, what guidance must a PI follow while conducting the clinical trial? Correct Answer: ICH E-6 Good Clinical Practice. Can an employee at the research site be witness to a patient's consent? Correct Answer: No, they are involved in the trial. Witness must be "a person who is independent of the trial, who cannot be unfairly influenced by people involved in the trial" What must a witness do before the consent process starts? Correct Answer: Read the consent form and other written information provided to the participant. They must also determine whether the participant has any other questions and should sign the impartial witness signature block on the consent document. If following ICH guidelines who all should sign the consent form between the subject, witness, and person obtaining consent. Correct Answer: All of them. Define: Oversee research involving human subjects to assure the protection of their rights, safety, and welfare. Correct Answer: IRBs/IECs FDA or ICH: requires the consent form to include a statement that "monitors, auditors, the IRB/IEC, and the regulatory authorities will be granted access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject is authorizing such access Correct Answer: ICH GCP FDA or ICH: Treatment alternatives only need to be listed in the consent form Correct Answer: FDA FDA or ICH: requires that the potential benefits and risks of the alternatives should also be included in the consent form. Correct Answer: ICH