good clinical practice is or gcp and why is it so important in clinical investigations

good clinical practice is or gcp and why is it so important in clinical investigations

hi there i'm maria niakar and i'm here to talk to you about clinical investigations for the past 15 years i've been working with medical device clinical development and clinical evaluation and i love to share my knowledge so if you want to learn more go to medical device hq or click on the link below and then you can register for my course but before we start make sure you subscribe to this youtube channel and also turn on the notification trust me you're going to love what we post now let's talk gcp asp gcp is an international quality standard which governments can transpose into regulation that decides how you must manage clinical trials involving human subjects good clinical practice is defined as an ethical and scientific quality standard for designing conducting recording and reporting trials that involve human subjects it provides the public assurance that the rights safety and well-being of the subjects have been protected and that the clinical data is credible the gcp guidelines ensures an ethical and scientific conduct of the study it should also ensure the protection of human rights for the subjects and volunteers participating in the study and one way to do this is to have a rigorous control of documentation the required documentation includes a clinical study protocol the clinical study protocol is a document that describes the study objectives the study design and methods assessment types collection schedules and statistical considerations for analyzing the data the protocol also outlines the steps for protecting subjects and obtaining quality data gcp required documentation also include how to set up and maintain documents related to general records related to clinical study records of how the study staff was trained records on qualifications on the clinical site and its facilities and records on quality assurance monitoring and auditing you may have seen the acronym ich in the context of gcp ich stands for the international council for harmonization of technical requirements for pharmaceuticals for human use wow i almost wasted my time there the mission of the ich is to promote public health by achieving greater harmonization of global drug development icas does this by developing technical guidelines and requirements that can be used by regulatory authorities and the pharmaceutical industry harmonization leads to more rational use of human and animals and other resources and it aims to eliminate unnecessary delays in the development of new therapies that's really great right gcp follows the ich and enforces tight guidelines on the ethical aspects of clinical research the gcp document therefore provides a unified standard for the european union switzerland canada japan the united states how to generate clinical data if you want to read more about the ich gcp guideline there's a link below the video let's switch gears now and learn more about my favorite standard the iso 14155 this standard was specifically developed for clinical investigations of medical devices and i think this standard is such an excellent tool to help you implement gcp when conducting clinical investigations for medical devices the first edition of the iso standard was published in 2003 the second revision in 2011 and the third and current version of the standard was published in july 2020 this course is based on the 2020 version of the standard the iso one for 155 standard is an excellent guidance and i encourage you to carefully read and understand it because it will almost certainly guarantee that you can set up and conduct clinical study with high regulatory compliance and scientific credibility similarly to the ich gcp the iso 14155 is also an international quality standard and governments use this to transpose it into regulations on how to manage clinical investigations with medical devices in human subjects both standards cover the protection of human rights for the subjects in clinical investigation this iso 14155 standard gives you really great and detailed instructions on how to set up and perform scientifically authentic clinical studies focusing on the safety and performance of medical devices it also helps you to understand how to properly document the clinical outcomes and everything related to the study to meet the requirements of the iso standard you have to create the well-structured and complete clinical investigation plan there's even a specific nx for this to help you with that it's the nxa of the iso one for 155 you also have to maintain a good organization of other important study documents it's called records the standard also describes how important it is to train study staff and how to qualify the clinical site and the facilities and finally how to maintain good quality assurance and perform monitoring and auditing as we have seen the purpose and fundamental principles of gcp and iso 14155 are the same in overlap but the ich gcp was written for pharmaceutical trials and the iso 14155 was written for medical device investigations now that you know the differences in basic principles is there something you would like to share or discuss leave a comment below and also connect with us on medicaldevicehq and on linkedin you can join our network of medical device industry people the more the merrier that's it for now thank you for watching and see you soon again [Music] you Videolytics