Investigator brochure - Study guides, Class notes & Summaries

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...

An IRB/IEC should safeguard the _______, _______, and ________ of all trial subjects. Special attention should be paid to trials that may include __________ subjects. correct answersRights, safety, and well being. Vulnerable. The IRB/IEC should obtain which documents? correct answersTrial protocol(s)/amendment(s). Written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, Subject recruitment procedures (e.g., advertisements), Written informa...

The _________ has developed the Declaration of Helsinki (DoH): - Answer World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of ________________ in medical research to protect the life, health, privacy and dignity of the human subject. - Answer the physician (DoH) In medical research, societal/scientific interest should always be prioritized after: - Answer ...

CCRP SOCRA Objective Assessment Guide Exam Questions and Already graded Solutions and Assured Satisfactions 2024/2025 An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than _ per year. - correct answer once Research may receive approval if there is a minority of the IRB members present at the convened meeting (T/F) - correct answer false Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of on...

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...

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 ...

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...

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 correct answersc. Formal Letter from the Institutional Review Board or Ethics Committee How do we document that a site's facilities are adequate to conduct the clinical trial?...

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...

MEGA SOCRA CCRP EXAM CONTENT REVIEW PRACTICE TEST. 5 - correct answer The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - correct answer In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - correct answer The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a ...