Gcp training exam - Study guides, Class notes & Summaries

CITI Training Exam Review Questions With Complete Solutions Latest Update (Graded A+). 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 th...

ACRP CCRC Exam Questions and Answers | Latest Update 2023/2024 GRADED A+. Audit Report - Answer Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Answer Documentation of audit events Single Blind Study - Answer Subjects Unaware Double Blind Study - Answer Subjects & Researchers are unaware Comparator - Answer Item used as an active control references in a clinical trail Coordinating Committee - An...

RA 10918 Exam Questions And Answers Latest Updated 2024/2025 (GRADED A+) RA 10918 Title - Answer Philippine Pharmacy Act Statement of Policy 10918 - Answer Recognize vital role of pharmacies in the delivery of quality healthcare services through provision of safe, effective and quality pharmaceutical products, etc. Statement of Policy 10918 - Answer Pharmacists professional services promoted as indispensable component of the total health care system to ensure physical wellbeing of Pinoys ...

ICH Good Clinical PracticeWhat is GCP? - correct answer You're probably wonder what Good Clinical Practice, or GCP, is exactly! In 1990, a conference called the International Conference on Harmonization took place and GCP guidelines were created. According to this document, GCP is: "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, ...

ICH GCP (CCRC) Exam Prep Questions and Answers | Latest 2023/2024 | Graded. Institutional Review Board Approval Correct Answer: The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements Audit Correct Answer: A systematic and independent examination of trial related activities and documents to d...

EXAM 2: GCP Review Questions and answers, rated A+ How do we document that a clinical trial has been reviewed and approved by an Institutional Review Board or Ethics Committee? a. Signed Investigator's Brochure Signature Page b. Signed Informed Consent Form c. Formal Letter from the Institutional Review Board or Ethics Committee d. Signed Protocol Signature Page - -c. Formal Letter from the Institutional Review Board or Ethics Committee How do we document that a site's facilities a...

CITI GCP Training, Exam Review Questions and answers, rated 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...

RA 10918 Exam Questions And Answers – Latest Updated 2024/2025 (GRADED A+) RA 10918 - Answer An act regulating and modernizing the practice of pharmacy in the Philippines, repealing for the purpose of RA 5921 known as Pharmacy Law RA 10918 Title - Answer Philippine Pharmacy Act Statement of Policy 10918 - Answer Recognize vital role of pharmacies in the delivery of quality healthcare services through provision of safe, effective and quality pharmaceutical products, etc. Statement of Poli...

CITI Training Exam Questions With Complete Solutions Latest Update (Score A+). 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 su...

ICH GCP Exam Questions and Answers | Latest Update 2023/2024 (GRADED). Clinical Trial/Study Report Correct Answer: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report Comparator (Product) Correct Answer: An investigational or marketed product, or placebo, used as a reference in a clinical trial. Complia...