subjects using medical devices i will be showing you the key provisions of the medical device specific gcp standard the iso 14155 and describe its role in the

welcome to this short course on clinical investigations for medical devices and the iso 14155 standard my name is maria niakar and i'm a clinical research professional and i've worked in the medical device industry for 15 years now and i'm very passionate to share my knowledge about clinical research and medical device technology and i hope you will enjoy this course as a consultant entrepreneur and founder of a medical device cro i have an excellent perspective of the current challenges that medical device manufacturers are facing when setting up clinical investigations in this video i will share my knowledge and understanding and help you set up clinical investigations of medical devices let's get started the goal of this short course is that you should get a basic understanding of what the clinical investigation for medical device is and why you should care about this and based on that you should be able to figure out if the full course on clinical investigations of medical devices and the iso 14155 standard that we offer medical device hq could help you in your job or career the full course is similar to this course but much more comprehensive and with more in-depth information and quizzes at the end of each topic to test your knowledge and understanding the full course also gives you an iso 141 gcp certificate at the end of the course which many auditors and employers will be looking for so what is the iso 14155 about well the first edition of this iso standard was published in 2003 and the second revision of the standard was released in 2011 and the third and current version of the standard was released in july 2020 this course is based on the 2020 version of the standard the iso 14155 standard is an excellent guidance document and i encourage you to carefully read it and understand it it will almost guarantee that you will set up and conduct clinical studies with high regulatory compliance and high scientific credibility so let's look at what clinical research is and why it's important clinical research is necessary to develop new treatments for different diseases and conditions that occur in humans to develop these new treatments we have to perform clinical studies to get proof that the new treatment works and that it's safe in humans clinical trials and studies using medical devices are called clinical investigations in the iso 14155 standard the term clinical trial or clinical study are synonymous with clinical investigation so clinical investigations are carried out to assess what works and does not work as treatment in humans and more elegantly this is described in the iso 14155 as clinical investigations is defined as any systematic investigation involving one or more human subjects undertaken to assess the clinical performance effectiveness or safety of a medical device so the purpose of the clinical investigation is to establish and verify clinical safety or establish and verify performance or establish and verify clinical benefits or detect any undesirable side effects i want to emphasize that clinical investigation should not be confused with the term clinical evaluation it is easy to misuse or use the terms interchangeably but it's important to know the difference so we know if we speak about one thing or the other so in other words a clinical investigation is when you're using a medical device on real patients to demonstrate the safety and performance of that medical device whereas the clinical evaluation is a theoretical and scientific assessment of existing data from many different clinical investigations and other sources of clinical data furthermore the clinical evaluation is about answering two important questions such as is there sufficient clinical evidence to confirm compliance with relevant requirements for safety and performance when using the device according to the instructions for use very few and is the clinical investigation needed now let's look a bit more in detail at clinical investigations so do all medical devices need a clinical investigation well here it's important to make a distinction between clinical research of drugs and clinical research of the devices so when studying new drugs a clinical trial is always required however when studying medical devices a clinical investigation may be required and this decision is based on the novelty of the device the risk classification of the device the outcome of the clinical evaluation and the conclusion from the risk analysis of the device you may think that why wouldn't all new medical devices need a clinical investigation how can you know that they're safe well if you are manufacturing a syringe or scalpel it might be possible to say that the device is safe and performs well by using results from relevant pre-clinical testing of that device including bench test in vitro test ex ex-vivo test animal tests and so on together with an evaluation of published literature on that device nevertheless in the united states all high-risk medical devices such as class 3 devices and some class 2 require a clinical investigation in the eu the european union all high risk devices such as class 3 devices and implantable medical devices require a clinical investigation some class 2 devices require clinical investigation too there may be some exceptions to this and in our course on scene marking on medical devices you can learn more about how to classify the risk of a medical device now that you know more about what clinical research is and what clinical investigations are let me bring you up to speed on what good clinical practice is so good clinical practice also known as gcp is an international quality standard that describes how to manage clinical trials involving human subjects governments can use this standard to transpose it into regulations for how to set up and manage clinical studies the gcp standard is an ethical and scientific quality standard for designing conducting recording and reporting clinical trials that involve human subjects it provides public assurance that the rights safety and well-being of subjects are protected and that clinical data is credible the gcp standard also established what is required in terms of how to prepare gcp required documentation such as a clinical study protocol how to maintain important records how to train study staff how to qualify the clinical sites and its facilities how to maintain quality assurance and perform monitoring and auditing you may have seen the acronym ich in the context of gcp the ich stands for the international council for harmonization of technical requirements for pharmaceuticals for human use wow i almost wasted my time there anyway the mission of ich is to promote public health by achieving a greater harmonization of global drug development the ich does this by developing technical guidelines and and requirements that can be used by the regulatory authorities and the pharmaceutical industry harmonization leads to more rational use of humans and animals and other resources it aims to eliminate unnecessary delays in the development of new therapies and that's really great isn't it so the gcp follows ich and enforces tight guidelines on the ethical aspects of clinical research the ich gcp document therefore provides a unified standard for the european union switzerland canada japan and the united states on how to generate clinical data now let's switch gears to one of my favorite standards the iso 14155 this standard was specifically developed for clinical investigations of medical devices it's an excellent tool to help you implement gcp when conducting clinical investigations for medical advices similarly to ica's gcp the iso 14155 is an international quality standard which governments also can use to transpose into regulations for how to manage clinical investigations with medical devices in human just like ich gcp this standard includes protection of human rights for the subjects in the clinical investigation the iso 14155 standard provides a detailed instruction on how to set up and perform a scientifically credible clinical study the standard also helps you understand how to properly document the clinical outcomes and everything else related to the study to meet the requirements of the iso standard you have to create the well-structured and complete clinical investigation plan the cip there's even a specific index to help you with this and xa of the iso 14155 you also have to keep a good organization of important study documents called records the standard also describes how important it is to train the study staff and how to qualify the clinical sites and the facilities and finally how to maintain quality assurance performing monitoring visits and auditing so it's clear that gcp and iso 14155 the standards are important and that remaining compliant with these standards is essential but who is responsible to ensure compliance let's look at this now who are the stakeholders that will ensure good clinical practice and make sure that it's implemented and followed we will look at the main part is now involved in clinical research the stakeholders that share responsibilities to ensure gcp compliance are the sponsor the principal investigator the research nurses and clinical research coordinators the ethics committees and the regulatory competent authorities the contract research organizations cros and monitors the medical monitor all these stakeholders are bound by three basic concepts and duties their ethical scientific and administrative responsibilities to summarize the sponsor is ultimately responsible for the clinical investigation the quality planning conduct as well as ensuring appropriate communication with the regulatory authorities such as the competent authority the investigator is responsible for the day-to-day conduct of the clinical investigation and the investigator must be qualified by education training and experience the ethics committee is the independent body that should give opinions on the ethical and scientific matters of the clinical investigation and the competent authority is the regulatory body that acts on behalf of the government to ensure that the legal requirements are applied any of the stakeholders can unfortunately and often without knowing it breach the requirements i outlined in the gcp and the iso 14155 standard much of our work as clinical research professional is to know that the gcp and the iso standards so well that we can anticipate and avoid making these mistakes in the full course we talk more about the breach of gcp serious protocol deviations and how to make sure that you can avoid this now that you understand the importance of the iso 14155 let's look at some of the specific sections and its requirements the standard released in 2020 has 10 clauses and 10 in excess three normative and access and seven informative it's almost twice as long as the previous standard version it starts by providing an overview of terms and definitions and there are quite a few of them actually 55. i can really recommend to carefully read them since it's very useful that you use the correct term that is widely accepted and well defined what is new in the 2020 version is a summary of the gcp principles which have been aligned with with the ica's gcp principles and this is presented in clause 4. this is an excellent summary the 13 gcp principles are summarized and start with that a clinical investigation must be conducted in accordance with the ethical principles that have their origin in the declaration of helsinki you also have to ensure that the foreseeable risks are weighed against anticipated benefits for the individual subject as well as the society the rights safety and well-being of human subjects are the most important consideration and should prevail over interest of science and of society the available preclinical and clinical information on the investigational device should be adequate to support the proposed clinical investigation and the clinical investigations must be scientifically sound and we described in a clearly detailed clinical investigation plan the cip the clinical investigation must receive prior ethics committee approval and approval from the regulatory authorities where needed the medical care given to the subjects and the medical decisions made is the responsibility of a qualified healthcare professional each person involved in designing conducting recording and reporting a clinical investigation must also be qualified by education training and experience to perform their task each subject should freely give an informed consent prior to the participation in the clinical investigation all clinical investigation related information should be recorded handled and securely stored the confidentiality of records that could identify subjects must be protected and respect the privacy and confidentiality rules investigational devices must be designed manufactured handled and stored correctly and they must be used in accordance with the approved clinical investigation plan and the ib and manufacturer's instructions for use and finally there should be a quality system in place with procedures that ensures the quality of every aspect of the clinical investigation i also want to show you that while clinical investigations of medical devices have many similarities to clinical trials for pharmaceuticals the regulatory evaluation of devices is distinct to that of drugs and there are critical differences in the way that device studies are designed and executed let's look at this so clinical research is broken up into series of phases each with a distinct purpose phase one to phase four pharmaceuticals must undergo the full clinical trial phase sequence before market release for medical devices the sequence is similar however most medical devices will go through clinical investigation stages instead of faces this table provides a side-to-side comparison of pharmaceutical trial phases versus medical device stages it also shows the main differences between the different phases and stages for drugs versus devices i know it contains a lot of information and in the full course we review this stage by stage and finally i would like to end this short course by speaking a bit about the clinical development process and the importance of carefully preparing a clinical research budget and to monitor costs and timelines i have prepared this flow chart outlining critical steps that you need to adequately plan and execute towards this is of course simplified and there could be many more pitfalls during this journey we will review all of these steps in the full course and you will learn how to anticipate some of these challenges and avoid some of the pitfalls clinical investigations are notorious for the complexity they typically take many years to reach completion and are often very costly but in this course you will see that there are several actions that you can take to optimize the process and make sure that you set up a successful study and even save money we have now come to the last part and with all that you have learned you have probably realized that you need to build a solid clinical budget to convince your manager the sponsor and possibly investors about the project's feasibility you will need to identify the key cost parameters for your clinical research project it is also important to make sure that you keep an eye on the differences in costs related to assessment specified in the clinical investigation plan and these costs are sometimes country specific in the full course we will review all the cost drivers and how to carefully craft a clinical research budget the better you plan your study from the beginning the more you can optimize your budget and control the costs remember if you're failing to plan you're planning to fail thank you for watching this short course i hope you found it interesting and valuable if you need templates to give you inspiration on how to write these clinical documents or if you require more knowledge on clinical investigations of medical devices on medical device hq you can find some free templates of essential documents that are required in clinical investigations or you can purchase the full course introduction to clinical investigations for medical devices and iso 14155 you can find that on medical device hq we offer online courses public classroom courses as well as in-house trainings on clinical investigations clinical evaluations cm marking risk management design control and project management for medical devices drop us a line on support at medicaldevicehq if you want to learn more about your options or receive a proposal you can also email us on the same email address if you have a question related to clinical investigations and clinical evaluation or share what you think are the most challenging topic in the clinical evaluation process i hope to see you soon again