Questions and Answers
How long should essential documents be retained after the last approval of a marketing application in an ICH region?
The financial aspects of a clinical trial do not need to be documented.
False
What should be submitted to the IRB/IEC by the investigator to report the trial status?
Written summaries
All serious adverse events (SAEs) should be reported immediately to the ________.
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Match each term with its corresponding requirement:
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What is the role of the investigator regarding changes that significantly affect the trial?
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What is the primary purpose of Good Clinical Practice (GCP)?
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An Independent Data-Monitoring Committee (IDMC) assesses the quality of a clinical trial only after it has been completed.
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What is the role of an Impartial Witness during the informed consent process?
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The __________ is an independent body that reviews and approves trial protocols to protect human subjects in clinical trials.
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Match the following terms with their definitions:
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Which group is responsible for modifying or stopping a clinical trial based on its interim safety and efficacy findings?
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What is the primary role of the principal investigator in a clinical trial?
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A multicentre trial is conducted under different protocols at multiple sites.
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What does the Investigator's Brochure provide?
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The act of overseeing the progress of a clinical trial is known as __________.
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Which entity provides judgment or advice regarding clinical trials?
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Match the following key terms with their correct definitions:
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A Monitoring Report is created after the completion of a clinical trial.
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What is meant by 'investigator/institution'?
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Study Notes
Good Clinical Practice (GCP)
- Serves as a standard for the entire clinical trial process: design, conduct, performance, monitoring, auditing, recording, analysis, and reporting.
- Ensures credibility and accuracy of data, while protecting the rights, integrity, and confidentiality of trial subjects.
Independent Data-Monitoring Committee (IDMC)
- An independent group established by the sponsor to evaluate clinical trial progress, safety data, and efficacy endpoints.
- Recommends whether to continue, modify, or halt the trial based on findings.
Impartial Witness
- An independent individual who witnesses the informed consent process, ensuring no undue influence from trial personnel.
- Reads the informed consent form if the subject or their representative cannot read it.
Independent Ethics Committee (IEC)
- Comprised of medical and non-medical members to review and approve trial protocols and investigator qualifications.
- Ensures the protection of human subjects’ rights, safety, and well-being, providing public assurance.
Document Retention
- Essential documents must be kept for at least two years post the last marketing application approval in an ICH region.
- Retention may extend beyond this period based on regulatory requirements or sponsorship agreements.
Financial Documentation
- Financial aspects of a clinical trial are detailed in a formal agreement between the sponsor and the investigator/institution.
Data Access
- Investigators/institutions must provide access to all trial-related records upon request from monitors, auditors, IRB/IEC, or regulatory authorities.
Progress Reports
- Investigators must submit annual written summaries of trial status to the IRB/IEC, or more frequently upon request.
- Prompt reporting of significant changes affecting the trial's conduct or increasing subject risks to the sponsor and IRB/IEC is mandatory.
Safety Reporting
- Serious adverse events (SAEs) must be reported immediately to the sponsor, with follow-up detailed written reports.
- The principal investigator is responsible for overseeing the trial team's operations.
Investigator/Institution Definition
- Refers collectively to the investigator and/or institution based on relevant regulatory stipulations.
Investigator's Brochure
- A comprehensive document containing essential clinical and nonclinical data regarding the investigational product relevant to its study in human subjects.
Legally Acceptable Representative
- An individual or entity authorized by law to consent on behalf of a prospective subject for clinical trial participation.
Monitoring
- Involves overseeing clinical trial progress to ensure adherence to protocols, SOPs, GCP, and regulatory requirements.
Monitoring Report
- A written communication from the monitor to the sponsor following each site visit or trial-related interaction, in accordance with SOPs.
Multicentre Trial
- A single protocol clinical trial conducted at multiple sites, involving more than one investigator.
Nonclinical Study
- Biomedical research not involving human subjects, focusing on laboratory or preclinical investigations.
Opinion of Independent Ethics Committee
- The judgment or advice given by the IEC regarding ethical considerations of the trial.
Original Medical Record
- Refers to the source documents utilized in clinical trials that serve as the original data for participants' medical history.
Protocol
- A formal document outlining the objectives, design, methodology, statistical considerations, and organizational details of a clinical trial.
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Description
This quiz focuses on the essential standards and practices of Good Clinical Practice (GCP) in clinical trials. It covers the critical components that ensure the integrity of data and the protection of trial subjects. Test your knowledge on GCP and related monitoring committees.
