give this AAD Educational Seminar on Good Clinical Protocol or GCP and Research Ethics. My name is Chi-Ho Hong and I'm a dermatologist that works in Surrey, British Columbia, Canada. I'm a member of Prokopy Medical Research and I've been conducting clinical research in my office for over 18 years. What is Good Clinical Protocol or GCP? Now, there's a disclaimer. Depending on local regulations, including those set by your local academic institution, there may be additional guidelines that must be fulfilled during the conduct of a clinical trial. This is only a high-level overview. All potential investigators should familiarize themselves with the most recent ICH GCP documentation. So, GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects is protected. The principles have their origin in the Declaration of Helsinki. ICH GCP, ICH is the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, and the ICH GCP guidelines is to provide a unifying standard for the EU, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Compliance with the ICH GCP standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The ICH GCP guidelines should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. There are multiple principles of ICH GCP, which I'll review here. Number one, clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and the applicable regulatory requirements. Number two, before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. Number three, the rights, safety, and well-being of trial subjects are the most important considerations and should prevail over interests of science and society. Number four, the available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. Number five, clinical trials should be scientifically sound and described in a clear and detailed protocol. Number six, a trial should be conducted in compliance with the protocol that has received prior institutional review board or independent ethics committee approval or favorable opinion. Number seven, the medical care given to and medical decisions made on behalf of subjects should always be the responsibility of a qualified physician or when appropriate of a qualified dentist. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective tasks. Number nine, freely given informed consent should be obtained from every subject prior to clinical trial participation. Number ten, all clinical information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification. This principle applies to all records referenced in this guideline, irrespective of the type of media used. Number eleven, the confidentiality of records that could identify subjects should be protected respecting the privacy and confidentiality rules in accordance with applicable regulatory requirements. Number twelve, investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice or GMP. It should be used in accordance with the approved protocol. And number thirteen, systems with procedures that assure the quality of every aspect of the trial should be implemented. Aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems. The institutional review board has responsibilities which include the safeguarding of rights, safety, and well-being of all trial subjects. They should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed, and the dates for the following approval, modifications, disapproval, or termination suspension of any prior approval. And the IRB should conduct a continuing review of each ongoing trial at least once per year. The IRB should consist of a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, the medical aspects, and ethics of the proposed trial. It is recommended that the IRB should include at least five members, of which at least one member whose primary area of interest is in a non-scientific area, and at least one member who is independent of the institution or trial site. Only those IRB members who are independent of the investigator and the sponsor of the trial should vote or provide opinion on a trial-related matter. The IRB should establish, document in writing, and follow its procedures, and specify that the investigator should promptly report to the IRB deviations from or changes of the protocol to eliminate immediate hazards to trial subjects, changes increasing the risk to subjects and are affecting significantly the conduct of the trial, all adverse drug reactions that are both serious and unexpected, and new information that may affect adversely the safety of the subjects or conduct of the trial. What does this all mean for investigators? Well, ICHGCP provides a framework under which all research trials are conducted to ensure data integrity and patient safety. That means as a researcher to conduct a research trial, you not only need to know and understand the ICHGCP guidelines, you must also be able to confirm compliance and adherence to the guidelines through appropriate documentation. And what does this really mean for investigators? It means that most research audits are ultimately audits of ICHGCP compliance. I want to thank you for your attention and for the academy for inviting me to do this video for you. Thank you very much.

Good Clinical Protocol

Declaration of Helsinki

International Council for Harmonization

informed consent

data integrity