Podcast
Questions and Answers
What is the definition of a serious adverse event or reaction?
What is the definition of a serious adverse event or reaction?
How soon must the sponsor report fatal or life-threatening SUSARs to the Ethics Committee and the Competent Authority?
How soon must the sponsor report fatal or life-threatening SUSARs to the Ethics Committee and the Competent Authority?
What is the purpose of the annual safety report submitted by the sponsor?
What is the purpose of the annual safety report submitted by the sponsor?
Who should the sponsor appoint to act as the main communication interface between the sponsor and the trial site?
Who should the sponsor appoint to act as the main communication interface between the sponsor and the trial site?
Signup and view all the answers
What is the role of clinical trial monitors in relation to laboratories or sponsor’s facilities?
What is the role of clinical trial monitors in relation to laboratories or sponsor’s facilities?
Signup and view all the answers
How soon must the sponsor inform the Competent Authority and the Ethics Committee of the end of a trial?
How soon must the sponsor inform the Competent Authority and the Ethics Committee of the end of a trial?
Signup and view all the answers
What is the purpose of SUSARs?
What is the purpose of SUSARs?
Signup and view all the answers
What should be reported in the annual safety report?
What should be reported in the annual safety report?
Signup and view all the answers
What is the role of the Ethics Committee in relation to adverse event reporting?
What is the role of the Ethics Committee in relation to adverse event reporting?
Signup and view all the answers
What is the purpose of GCP?
What is the purpose of GCP?
Signup and view all the answers
Study Notes
Clinical Regulations
- Clinical trials are a critical stage in the regulatory process, establishing the safety and efficacy of a drug in humans.
- Regulations governing clinical trials ensure the safety, welfare, and rights of subjects participating in the trials are protected, and scientifically useful and valid data are collected.
Clinical Trials
- Purpose: Establish a drug therapy that is safe and effective in humans, with an acceptable risk-benefit relationship.
- ICH definition: Investigations in human subjects to discover or verify clinical, pharmacological, and/or pharmacodynamic effects of an investigational medicinal product.
- Process: Phase I, Phase II, and Phase III; Phase IV: Safety studies (may be conducted post-approval).
Clinical Trial Design
- Key element: Ensure scientific validity and objectivity, demonstrating a positive benefit to risk outcome.
- Studies can be broadly divided into two types: confirmatory studies (to prove or disprove pre-defined hypotheses) and exploratory studies (where outcomes may not be clear in advance).
- Designed to minimize potential sources of bias, e.g., blinded trial designs.
Good Clinical Practice (GCP)
- Must be conducted in accordance with GCP principles, an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials.
- Ensures the rights, safety, and well-being of trial subjects are protected, and clinical trial data are credible.
- Harmonized guidance document on GCP developed by ICH (ICH E6).
The Sponsor
- Initiates the process of conducting clinical trials, responsible for initiation, management, and/or financing.
- Ensures trials are conducted according to regulations and GCP principles.
- Responsible for documenting, analyzing, and reporting data according to established SOPs.
The Investigator's Brochure (IB)
- Compilation of available clinical and non-clinical data on the investigational medicinal product.
- Includes a description of the physical, chemical, and pharmaceutical properties of the drug substance and product.
- Provides investigators with sufficient information to facilitate their understanding of the trial protocol.
The Investigator
- Responsible for the conduct of the trial at the trial site.
- Must be a doctor or other appropriately qualified medical personnel.
- Manages recruitment of subjects, administration of drugs, and monitoring and recording of responses.
- Ultimate purpose is to guard the health and welfare of subjects.
Clinical Trial Application (CTA)
- Submission to the competent National Regulatory Authority for obtaining authorization to conduct a clinical trial in a specific country.
- Provides necessary information on investigational medicinal products.
Independent Ethics Committee
- Focuses on ensuring the rights, safety, and welfare of human subjects involved in a trial are protected.
- Generates public confidence in the process.
- Consists of both healthcare professionals and lay members.
Amendments to Clinical Trials
- Sponsor may need to amend a clinical trial due to new information.
- Notifies the Competent Authority and the Ethics Committee using a Trial Amendment Form.
- Ethics Committee has 35 days to approve the amendment.
Case Report Forms (CRFs)
- Record all protocol-required data at the trial site.
- Data for individual subjects are recorded on separate CRFs.
- Used to transfer trial data to the sponsor for analysis and evaluation.
Adverse Event Reporting
- Serious adverse event or reaction: any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability.
- Suspected Unexpected Serious Adverse Reactions (SUSARs): reported to the Ethics Committee and the Competent Authority within 7 days (fatal or life-threatening) or 15 days.
Annual Safety Report
- Sponsors submit a safety report to the Competent Authority and the Ethics Committee once a year throughout the clinical trial.
- Covers SUSARs, other serious adverse reactions, and an analysis of the subject's safety during the trial.
Monitoring of Trials
- Sponsor appoints clinical trial monitors to oversee that trials are conducted and correctly documented in accordance with the protocol and GCP.
- Monitors regularly visit the trial site to verify that related laboratories or sponsor's facilities are conducted in accordance with applicable protocols, procedures, regulations, GCP, and GLP.
End of Trial
- Sponsor must inform the Competent Authority and the Ethics Committee of the end of a trial within 90 days of its completion.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
This quiz covers the critical stage in the regulatory process, establishing the safety and efficacy of a drug in humans, and the regulations governing it.
