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Clinical Trial Regulations: Informed Consent, IRB, and Investigator Responsibilities, Exams of Law

Duke UniversityLaw

A concise overview of key concepts and regulations related to clinical trials, focusing on informed consent, irb responsibilities, and investigator obligations. It covers essential elements of the informed consent process, including the 8 basic elements of icf, and the differences between long and short icf forms. The document also outlines the roles and responsibilities of sponsors and investigators, emphasizing compliance with fda regulations and the importance of data safety monitoring. It is a useful resource for understanding the regulatory landscape of clinical research. The document also touches on medical device classification and regulatory pathways, providing a comprehensive overview of the clinical trial process.

Typology: Exams

2024/2025

Available from 06/07/2025

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learningbridge 🇺🇸

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SOCRA CCRP ACTUAL exam questions and CORRECT
answers|100% GUARANTEED PASS
graded A+| Updated & Verified | 2025
Timeline of Historical Events - ✔✔Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report
1979
The Three Principles of the Belmont Report - ✔✔respect for persons, beneficence, justice
Application of Respect for Persons - ✔✔informed consent (autonomy, choose for themselves)
Application of Beneficence - ✔✔risk/benefit analysis
Application of Justice - ✔✔appropriate selection of patients (equality)
Language Level ICF - ✔✔6th-8th grade
8 basic elements of ICF - ✔✔1. purpose, duration, and procedures
2. risks/discomforts
3. benefits
4. alternatives
5. confidentiality
6. compensation/medical treatments injury
7. contact information
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Download Clinical Trial Regulations: Informed Consent, IRB, and Investigator Responsibilities and more Exams Law in PDF only on Docsity!

SOCRA CCRP ACTUAL exam questions and CORRECT

answers|100% GUARANTEED PASS

graded A+| Updated & Verified | 2025

Timeline of Historical Events - ✔✔Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - ✔✔respect for persons, beneficence, justice Application of Respect for Persons - ✔✔informed consent (autonomy, choose for themselves) Application of Beneficence - ✔✔risk/benefit analysis Application of Justice - ✔✔appropriate selection of patients (equality) Language Level ICF - ✔✔6th-8th grade 8 basic elements of ICF - ✔✔1. purpose, duration, and procedures

  1. risks/discomforts
  2. benefits
  3. alternatives
  4. confidentiality
  5. compensation/medical treatments injury
  6. contact information
  1. voluntary participation and discontinuation at any time Long ICF - ✔✔standard consent form Short ICF - ✔✔a document that elements of ICF, orally stated, understood by participant 4 components of consent process for short form - ✔✔1. short form document
  2. oral presentation of ICF elements
  3. IRB approved summary
  4. a witness When can you use short form? - ✔✔language, short window ICF monitoring - ✔✔1. most recent IRB approved version
  5. signature present
  6. subject dated/correct date
  7. errors corrected by a single line
  8. all pages present SAE Reporting Requirement - ✔✔immediately investigator, 15 days for sponsor UADE Reporting Requirement - ✔✔ 10 days investigator, 10 days for sponsor

Data Safety Monitoring Board (DSMB) - ✔✔a group of experts that reviews research data 3 primary investigator responsibilties - ✔✔1. oversee the conduct of the trial

  1. protect the rights, safety, and welfare of subjects
  2. control the use of the investigational product Significance of FDA 1572 and investigator agreement (device) - ✔✔a declaration of the investigator to comply with FDA regulations Commitment of Investigator listed on 1572 - ✔✔1. follow the protocol
  3. personally conduct or supervise the study
  4. obtain informed consent
  5. report AE
  6. properly train staff
  7. maintain records
  8. ensure compliant IRB oversees
  9. comply with all other CFR requirements FDA dateline for investigator reporting SAE(s) (drug) - ✔✔does not give specific, just immediately report to sponsor, and promptly to IRB

FDA dateline for investigator reporting SAE(s) (device) - ✔✔does give specific, within 10 working days after discovery Investigator Responsibilities for ICF - ✔✔- obtain legally effective informed consent

  • provide sufficient opportunity to decide
  • minimize coercion or undo influence
  • language understandable to the subject
  • avoid exculpatory (waive legal rights)
  • current version of IRB approved ICF Show ICF obtained prior to study procedures - ✔✔to record the time of consent Definition of essential documents - ✔✔documents that permit evaluation of the conduct of a trial and the quality of the data produced Time required to keep clinical trial records at site - ✔✔ 2 years after FDA approval or 2 years after study ended Quality Control (QC) focuses on what? - ✔✔identification and correction Quality Assurance (QA) focuses on what? - ✔✔prevention Corrective And Preventive Actions (CAPA) process - ✔✔to identify root cause of issues or problems and actions to resolve them
  • Signed protocol
  • FDF Sponsor must choose who to oversee the trial? - ✔✔a qualified monitor Other sponsor responsibilties - ✔✔- monitor the progress
  • secure compliance or discontinue shipment of IP
  • review safety and efficacy data and report safety issues to FDA
  • submit annual reports to FDA
  • discontinue use of IP that cause significant risk, notify FDA 5 working days, destroy IP, and submit full report to FDA of study closure How long does a sponsor have to submit IND safety report? - ✔✔within 15 calendar days after knowing How many days does sponsor have to submit additional information to FDA? - ✔✔within 15 calendar days after receiving request How long does sponsor have to notify FDA of unexpected fatal or life-threatening suspected adverse reaction? - ✔✔within 7 calendar days of initial receipt of info How long does the sponsor have to report unanticipated adverse device affects (UADE)? - ✔✔within 10 working days of receipt of the info

Items to be considered for an electronic record system - ✔✔- completeness, accuracy, reliability, consistency, and ability to detect invalid records

  • SOP usage
  • audit trail
  • limited access
  • back-up
  • checking systems (operational, authority, device)
  • qualified personnel
  • accountability of misconduct/falsification
  • authenticity, integrity, and confidentiality Record retention requirements for drug sponsor - ✔✔ 2 years after approval or 2 years after last shipment of IP and FDA notified Record retention for device sponsor - ✔✔ 2 years after study completion or 2 years after PMA date or date on notice of completion Phases of drug development - ✔✔- Discovery (screening of small molecules, natural products, extract)
  • Pre-clinical (animal testing, PK, PD)
  • Phase 0 (PK and PD in humans), Phase I (safety), Phase II (efficacy), Phase III (pivotal studies), Phase IV (post marketing surveillance) Medical Device Classification - ✔✔- Class I- general controls (bandages, gloves)
  1. voluntary action indicated
  2. no action indicated Focus areas during FDA inspection of site - ✔✔- personnel and organization
  • facility
  • IRB approval
  • protocol adherance
  • documentation of informed consent
  • data collection
  • IP accountability
  • financial disclosure
  • clinical trial oversight/ monitoring
  • electronic data
  • adverse evnts
  • record retention