Generated by Rank Math SEO, this is an llms.txt file designed to help LLMs better understand and index this website. # GCP Central ## Sitemaps [XML Sitemap](https://gcpcentral.com/sitemap_index.xml): Includes all crawlable and indexable pages. ## Posts - [What Annex 2 of ICH E6(R3) Means for Clinical Research](https://gcpcentral.com/gcp-central-news/what-annex-2-of-ich-e6r3/): Annex 2 of ICH E6(R3) has been developed with these changes in mind. Rather than creating a new set of Good Clinical Practice (GCP) principles, it builds on Annex 1 by explaining how existing GCP expectations should be applied. - [ICH GCP E6(R3) in practice: Modernizing oversight for a digital world](https://gcpcentral.com/gcp-central-news/ich-gcp-e6r3-in-practice-modernizing-oversight-for-a-digital-world/): The shift from reading regulatory updates to running a live trial brings immediate pressure. With the International Council for Harmonisation Good Clinical Practice (ICH GCP) E6(R3) principles and Annex 1 now active in Europe, the industry has moved past the era of simple preparation. Every organization must now prove it can apply these modernized standards to daily operations. - [What Clinical Research Teams Need to Know About the EU AI Act in 2026](https://gcpcentral.com/updates-law-regulations/eu-ai-act-in-2026/): The EU AI Act is no longer a proposal. It is law, and it applies in stages. The European Commission sets out the application timeline, including key dates in 2025 and 2026, with some obligations running on longer transition periods into 2027. - [Rethinking Sponsor Oversight for AI-Enabled Trial Delivery Under ICH E6(R3)](https://gcpcentral.com/gcp-central-news/rethinking-sponsor-oversight-for-ai-enabled-trial-delivery-under-ich-e6r3/): ICH E6(R3) has moved from guideline text to regulatory expectation across Europe. At the same time, trial delivery is becoming more platform-driven, more vendor-distributed, and increasingly supported by AI-enabled functions inside those systems. - [GCP-WMO re-certification in the Netherlands: shorter training, stronger knowledge](https://gcpcentral.com/gcp-central-news/gcp-wmo-re-certification-training/): GCP Central has redesigned its GCP-WMO Re-certification course with that reality in mind. The new version keeps full alignment with the requirements of the GCP-WMO register, is updated to ICH GCP E6(R3), and can be completed in approximately three hours. This article outlines how re-certification works in practice, what happens with EMWO after you finish the course, and what has changed in the training itself. - [GCP Central Launches ICH GCP (E6) R3 Transition Training ](https://gcpcentral.com/gcp-central-news/gcp-central-launches-ich-gcp-e6-r3-transition-training/): To help you stay compliant and implement these updates effectively, GCP Central has launched the ICH GCP R2 to R3 Transition Course,  a self-paced, interactive training designed for sponsors, investigators, and service providers such as CROs.  - [Meet the Team: Introducing Femke Kuiper, Business Development Manager ](https://gcpcentral.com/gcp-central-news/meet-the-team-introducing-femke-kuiper-business-development-manager/): GCP Central is pleased to welcome Femke Kuiper as our newest Business Development Manager. With over 20 years of experience in the pharmaceutical, medical device, and animal health industries, she brings a wealth of expertise in sales, marketing, and project management. Her passion for connecting with people and her competitive spirit make her a valuable addition to the team.  - [ICH GCP R3: Updated Timelines and What’s Happening Next](https://gcpcentral.com/gcp-central-news/ich-gcp-r3-updated-timelines-and-whats-happening-next/): ICH GCP R3: Updated Timelines and What’s Happening Next - The International Council for Harmonisation (ICH) is making critical updates to its Good Clinical Practice (GCP) guidelines under Revision 3 (R3). These changes aim to modernize clinical trial practices and adapt to the evolving needs of research. Here’s a detailed look at the latest developments, updated timelines, and what’s ahead. - [Preparing for the ICH GCP E6 R3 update: What learners need to know](https://gcpcentral.com/updates-law-regulations/preparing-for-ich-gcp-e6-r3/): The ICH-GCP R3 intends to address the application of the GCP guideline to the increasingly diverse trial types and data sources being employed in drug development. As clinical trials and with that, it’s guidelines and regulations evolve, it is crucial for professionals in the industry to stay informed and adapt. This article explores what learners need to know about the upcoming Good Clinical Practice update and how GCP Central’s innovative GCP training can help them succeed.  - [Case Study: Controlled validation management of the myGCP application with ION Pharma](https://gcpcentral.com/gcp-central-news/case-study-controlled-validation-management-of-the-mygcp-application-with-ion-pharma/): Originally posted on the ION Pharma website here. - [GCP Central, e-learning provider for clinical research, joins Reducate EdTech Group](https://gcpcentral.com/gcp-central-news/gcp-central-e-learning-provider-for-clinical-research-joins-reducate-edtech-group/): Utrecht, September 11th, 2024 – Reducate EdTech Group, a leading player in professional online continuing education, announced the acquisition of Amsterdam-based GCP Central today. Reducate serves more than 175,000 professionals in more than 40 different professions with eCPE.  - [GCP Central and NFU Launch Innovative eBROK® Course for Continuous Learning in Clinical Research](https://gcpcentral.com/gcp-central-news/gcp-central-and-nfu-launch-innovative-ebrok-course/): GCP Central is proud to announce the launch of the eBROK® course that was built for the Netherlands Federation of University Medical Centres (NFU). - [Implementation of ICH GCP E6 (R3) Update: Key Points and Process Overview ](https://gcpcentral.com/updates-law-regulations/implementation-of-ich-e6-r3/): The update to the ICH E6(R3) guideline is currently in its final stages. Step 3 and 4 are, as currently discussed in the ICH Assembly meeting in Japan, expected around October 2024. If that timeline indeed is met, the updated Good Clinical Practice Principles and Annex I will be adopted in October 2024. This allows for regional implementation to commence from that point, which could be within a timeframe of 1 month, depending on the region.    - [CONTINUOUS LEARNING: ONE OF OUR BUILDING BLOCKS](https://gcpcentral.com/gcp-central-products/continuous-learning-one-of-our-building-blocks/): Continuous learning is not just a trendy term. It stands for continuing education, which, compared to older learning methods, is a much more efficient way to keep knowledge and qualifications up to date. You also stay abreast of new developments more easily. We embrace this way of learning and are increasingly implementing it in our training courses. - [Navigating the European Medical Device Regulation Changes: A Guide for Clinical Research Professionals](https://gcpcentral.com/gcp-central-products/navigating-the-european-medical-device-regulation/): In clinical research, staying up to date with regulatory changes is paramount to ensuring the safety and efficacy of medical devices. With the implementation of the European Medical Device Regulation (MDR), effective from May 26, 2021, significant shifts have occurred in the landscape of medical device trials. These changes dictate the timelines and protocols for new trials and necessitate adjustments to existing ones. - [Interview with Prisca van Leeuwen: “Having your own little store in the store”](https://gcpcentral.com/gcp-central-news/interview-with-prisca-van-leeuwen-having-your-own-little-store-in-the-store/): Prisca van Leeuwen is the one subjected to our Q&A this time. This good-humored pharmacy assistant from the Groene Hart Hospital has a passion for clinical trials. - [MDR VS MDD: WHAT YOU NEED TO KNOW](https://gcpcentral.com/gcp-central-products/mdr-vs-mdd/): The Medical Device Directive (MDD) has governed medical device regulation within the European Union since its inception in 1993. However, the evolution of technology and the healthcare landscape has rendered the MDD outdated. Consequently, a pressing necessity arises for a more comprehensive regulatory framework attuned to contemporary technological advancements. - [FAQ: HOW CAN I open My Certificate?](https://gcpcentral.com/gcp-central-news/faq-why-cant-i-open-my-certificate/): This month’s frequently asked question: Why can’t I open my certificate?  With the upcoming ICH GCP R3 update, and the need for innovative and up-to-date training, it’s also essential to have access to your certificates, and know how long they’re valid for.   - [FAQ: Transition to EU CTR – No need to panic!](https://gcpcentral.com/gcp-central-news/faq-transition-to-eu-ctr-no-need-to-panic/): We are getting more and more questions about the EU CTR. The transition period is about to end, and we ‘re noticing it. That’s why we would like to share with you the most critical issues: - [NFU assigns development of future-proof eBROK® course to GCP Central](https://gcpcentral.com/gcp-central-news/gcp-central-to-develop-ebrok/): The Nederlandse federatie van umc's (NFU) (English: Dutch Federation of University Medical Centers) has awarded GCP Central the contract to develop further and maintain the e BROK® course from 2024 to 2027. - [Interview with Jacintha Ronden: “The best thing about doing research is still the collaboration.”](https://gcpcentral.com/gcp-central-news/interview-with-jacintha-ronden-the-best-thing-about-doing-research-is-still-the-collaboration/): This time, we spoke to Jacintha Ronden of Cardialysis. We congratulated her on her promotion from project manager to department manager last week. - [ICH-GCP R3: Why Innovative ICH-GCP Training Matters  ](https://gcpcentral.com/gcp-central-products/why-innovative-ich-gcp-training-matters/): why do we also emphasize things like quality training and the validity of GCP certificates? Here's an overview of why innovative ICH-GCP training matters. - [ICH GCP R3 – What should we expect? Part 2 ](https://gcpcentral.com/updates-law-regulations/ich-gcp-r3-what-should-we-expect-part-2/): Since ICH-GCP (or officially, ICH E6 R1) was first drafted more than 20 years ago, the complexity of clinical trials has increased, with the design of trials, technology use, and data quality and collection changing to the evolving face of research.   - [Interview with Jiska Meijer “Looking in depth and daring to make mistakes”](https://gcpcentral.com/gcp-central-news/interview-with-jiska-meijer-looking-in-depth-and-daring-to-make-mistakes/): The third person to speak in this series is Jiska Meijer, a general practitioner with a PhD, co-founder of GPRI and deputy head of general practitioner training at the UMCG since the beginning of this year. - [You win some, you lose some. ](https://gcpcentral.com/gcp-central-news/you-win-some-you-lose-some/): Last year we, Marieke Meulemans (CEO of GCP Central) and Valerie Prins (now copywriter of GCP Central), had a fantastic adventure together. We participated in the Hockey World Cup for 35+. We got to know each other at that tournament, and the first seed was planned for our cooperation and hockey friendship. - [ICH-GCP R3: What should we expect? Part 1 ](https://gcpcentral.com/updates-law-regulations/ich-gcp-r3-what-should-we-expect-part-1/): The first update to ICH-GCP (r2) was published in 2016 and focused on a risk-based approach to clinical trials and their design and conduct. However, since the publication of this update, clinical trials have continued to evolve with new designs and technological innovations. The upcoming update of ICH GCP (Good Clinical Practice), the E6(R3), will be designed to advance the concept of risk-based approach further and encourage relevant parties to utilize it.  In Part 1 of this series, we will talk about the overall changes expected in ICH-GCP R3, and in Part 2, we will explore the changes to the annexes. - [Decentralized Clinical Trials – The Research of The Future ](https://gcpcentral.com/gcp-central-products/decentralized-clinical-trials-the-research-of-the-future/): More and more studies are being conducted involving staff who don't handle all aspects of GCP, especially in Decentralized Clinical Trials. There is a lot of uncertainty about what these people need to know about Good Clinical Practice.   - [HOW LONG IS MY GCP CERTIFICATE VALID?](https://gcpcentral.com/gcp-central-products/my-gcp-certificate-valid/): How long is my GCP certificate valid? This is one of our frequently asked questions. While some companies offer certificates for 2, 3or 4 years, at GCP Central we take our training a little more indepth.  In this article, we'll go over some key factors about our GCP training, and explore the depths of how long our training lasts. - [Interview With Manon Haanepen-Witkamp: “Nothing Is Standard Here And I Like That”](https://gcpcentral.com/experiences/interview-with-manon-haanepen-witkamp-nothing-is-standard-here-and-i-like-that/): And that is precisely Manon's strength. She derives great pleasure from the fact that there is "There is always something new, there is always something to figure out. Nothing is standard here and I like that then." - [Meet The Team: Introducing Wan Yen, Business Developer ](https://gcpcentral.com/gcp-central-news/meet-the-team-introducing-wan-yen-business-developer/): With extensive experience in pharmaceuticals and Good Clinical Practice, Wan Yen joined our team recently as a Business Developer.  This blog will take a few moments to learn more about her, her experience, and what she hopes to bring to GCP Central.   - [Mygcp powerapp: acknowledge your knowledge part 3](https://gcpcentral.com/gcp-central-news/mygcp-powerapp-acknowledge-your-knowledge-part-3/): We will soon be launching our new myGCP Powerapp. We are incredibly excited about it and will give you an insight into its development in this blog. Why this app? - [The Medical Device Regulation: Why a Delay in Implementation, and What is The Impact on Your Clinical Trials?  ](https://gcpcentral.com/gcp-central-news/the-medical-device-regulation-why-a-delay-in-implementation-and-what-is-the-impact-on-your-clinical-trials/): With the European Commission recently adopting a proposal to give a longer transition time to adapt to the Medical Device Regulation (MDR), important questions to pose are why this delay and how does it impact your clinical research-related work?   - [MyGCP Powerapp: Acknowledge Your Knowledge Part 2](https://gcpcentral.com/gcp-central-news/mygcp-powerapp-acknowledge-your-knowledge-part-2/): This 3-part series will take you through the app's whys and hows and the pilot experiences. You could read in the previous part about our motivation to develop the powerapp. Now we take a closer look at how the app works. - [Interview with Anne van der Plas: “All the little steps are fascinating.”](https://gcpcentral.com/gcp-central-news/interview-with-anne-van-der-plas-all-the-little-steps-are-fascinating/): "I liked how you set it up; you really get involved in thinking about the topic." - [MyGCP Powerapp: Acknowledge your knowledge](https://gcpcentral.com/gcp-central-news/mygcp-powerapp-acknowledge-your-knowledge/): We're close to launching our new myGCP Powerapp and are incredibly excited about it. We'd love to give you some insight into the app's development in this blog - [Medical Device Regulation: The Need for Clinical Expert Involvement](https://gcpcentral.com/gcp-central-products/medical-device-regulation-clinical-expert/): In this guest blog from Esther Daemen, we look at the need for the involvement of clinical experts in developing new medical devices, from concept to completion, and the importance of adhering to the new Medical Device Regulation (MDR). - [EU CTR And CTIS: First Learnings From Working With CTIS And When Known Issues Will Be Solved. ](https://gcpcentral.com/gcp-central-news/eu-ctr-and-ctis-first-learnings-from-working-with-ctis-and-when-known-issues-will-be-solved/): This is the third and final part of a series of articles where GCP Central goes in-depth into the challenges, learnings, and critical findings of implementing the new European Clinical Trials Regulation (EU CTR). In this instalment, we look at issues encountered in this first year of working with CTIS and essential information about how to cope with these.  - [Implementing the EU CTR: Publishing Clinical Trial Reports and Transparency ](https://gcpcentral.com/gcp-central-news/implementing-the-eu-ctr-publishing-clinical-trial-reports-and-transparency/): It is essential that the results of clinical trials are publicly available. To ensure clinical trials (and their sponsors) are trusted, but most of all, to prevent participants from unnecessary studies. Let us find out where data from clinical trials within the EU can be accessed. - [Implementing CTIS: What you Should Know](https://gcpcentral.com/gcp-central-news/implementing-ctis-what-you-should-know/): This is the first in a series of articles where GCP Central goes in-depth into the challenges, learnings, and critical findings of implementing the new European Clinical Trials Regulation (EU CTR). In this instalment, we reflect on the Clinical Trials Information System (CTIS), the unique single-entry point and database for clinical trials, and the issues surrounding the slower system adoption. - [Checking In – Are You Inspection Ready with MDR and EUCTR?](https://gcpcentral.com/gcp-central-news/checking-in-are-you-inspection-ready-with-mdr-and-euctr/): In the past few months, 2 new regulations have been put into place in the world of clinical trials. The EU Clinical Trials Regulation and the Medical Devices Regulation (MDR) (EU 2017/745) have been implemented. This has created a new need for training teams to streamline trials, and be compliant.   - [Why your team needs MDR training: From an Expert](https://gcpcentral.com/gcp-central-products/why-your-team-needs-mdr-training-from-an-expert/): Get your training here: For MDR training in the Netherlands, click here. For MDR training in Europe, click here. - [Are you EU CTR Ready? Our must-have Checklist for January 31, 2022.](https://gcpcentral.com/gcp-central-news/are-you-eu-ctr-ready-our-must-have-checklist-for-january-31-2022/): Today's the day the EU CTR comes into effect. This new legislation will majorly impact organizations involved in the design and implementation of clinical trials. - [January 31, 2022: EU CTR goes Live. Are you ready?](https://gcpcentral.com/gcp-central-products/january-31-2022-eu-ctr-goes-live-are-you-ready/): On the 31st of January, 2022, the European Commission's new clinical trial legislation will come into effect. With the hope of creating a better environment to conduct clinical trials within the EU, the European Clinical Trials Regulation (EU CTR 536/2014) creates a uniform standard that all future trials will need to adhere to when conducting trials for medicinal products for human use.   - [EU CTR and VGO: what impact do they have on research in the Netherlands? Reflections from the field: Thera Max-Mos, Sanofi](https://gcpcentral.com/gcp-central-news/eu-ctr-and-vgo-what-impact-do-they-have-on-research-in-the-netherlands/): We spoke with Sanofi's Thera Max-Mos, Head Clinical Study Unit ai, NL, to discuss these changes. We look at the impact this has had on the study and any teething problems in the procedure. She also shares her thoughts on the upcoming EU CTR introduction. - [ECTR And MDR: Marieke Meulemans Presenting At The SCRS European Site Solutions Virtual Summit](https://gcpcentral.com/gcp-central-news/marieke-meulemans-presents-at-eu-site-solutions-summit/): We’re proud to announce that Marieke Meulemans will present  “ European Clinical Trial Regulation (ECTR) and Medical Device Regulation (MDR)” on April 21st, 2021, with co-panelists  Rianne Tooten and Isabelle van der Haegen. This session will be held between 13:15 and 14:00, EMT, as part of the SCRS EU Site Solutions Summit. Vivienne van der Walle will facilitate the session - [Expanding Our Course Catalog with a New German Refresher ICH GCP Course](https://gcpcentral.com/gcp-central-news/expanding-our-course-catalog-with-a-new-german-refresher-ich-gcp-course/): Our Refresher ICH GCP Course is designed for study nurses and members of an investigational team who need to refresh their knowledge of the German Medicines Act (AMG) applicable to clinical drug research with human subjects (Arzneimittelstudien). - [Introducing Our New Good Manufacturing Practice (GMP) Online Course](https://gcpcentral.com/gcp-central-news/introducing-our-new-good-manufacturing-practice-gmp-online-course/): Our new Good Manufacturing Practice (GMP) online course covers the legal requirements and best practices for quality oversight on external manufacturing. Learn more about it here. - [Software Update 2.11: What’s New in myGCP?](https://gcpcentral.com/mygcp-software-release/software-update-2-11-whats-new-in-mygcp/): In our ongoing commitment to high-quality GCP training, as well as providing you with the latest updates available, myGCP will undergo a software update - [Announcing New ICH-GCP Course for Sponsors in International Clinical Trials](https://gcpcentral.com/gcp-central-news/announcing-new-ich-gcp-course-for-sponsors-in-international-clinical-trials/): Announcing the latest addition to the GCP Central online course offerings: Expert ICH GCP Course for Sponsors in International Clinical Trials. - [Your GCP Learning Preferences Discovered](https://gcpcentral.com/gcp-central-news/your-gcp-learning-preferences-discovered/): We invited myGCP users and other life science professionals who are non-myGCP users to complete a survey about their GCP learning preferences. We also included questions around when and how they would like to learn about the rules and regulations that apply to clinical research. - [The Most Popular International myGCP Courses Of 2020](https://gcpcentral.com/gcp-central-news/the-most-popular-international-mygcp-courses-of-2020/): 2020 has been an unprecedented year of change; companies, organizations, and individuals needed to evolve and adapt how they work, train quickly, and study like never before. - [Simple Steps To Creating Your myGCP Account](https://gcpcentral.com/gcp-central-news/simple-steps-to-creating-your-mygcp-account/): Managing our time effectively at work is a constant challenge, made even more problematic when it's time to attend training sessions or seminars to keep our skills current.  We can end up losing valuable time in our already jam-packed schedules. But what if there was an easier way? - [GCP Central Launches Online CFR training Course For Clinical Trials In The USA](https://gcpcentral.com/gcp-central-news/gcp-central-launches-online-cfr-training-course/): Introducing the newest online course from GCP Central – Basic CFR Course for Clinical Trials In The USA. Learn about the principles of the Code of Federal Regulations that are required for the conduct of clinical trials in the USA … - [Announcing the launch of our refreshed website](https://gcpcentral.com/gcp-central-news/announcing-the-launch-of-our-refreshed-website/): It's official, after months of hard work and dedication, it's time to launch our refreshed website. We wanted to make the new website faster, easier to navigate, and more user-friendly while re-focusing it to feature our entire GCP course library. We also added some practical and useful new functionalities to make sure you can find the right course that's fit for your needs. - [Which course is right for me? Plans unveiled for course title updates](https://gcpcentral.com/gcp-central-news/plans-unveiled-for-course-title-updates/): Did you know that over the past year, we have increased the number of courses we offer by 400%? As our company has grown, so has our GCP training course portfolio, providing a more extensive range of courses catering to both the Dutch and English-speaking research communities Our commitment is to provide a better way of training, and we are changing our course titles to help you more easily find the course you need. - [Validation in 6 Steps: How to Validate Computerized Systems in Clinical Research](https://gcpcentral.com/experiences/validation-in-6-steps-validating-computerized-systems-in-clinical-research/): The Validation of software tools used in the conduct of clinical trials is listed as a requirement described in ICH-GCP guidelines. Learn more about the six steps of the Validation process here… - [3 Reasons Your Clinical Research Team Needs Online Learning Now](https://gcpcentral.com/gcp-central-products/3-reasons-your-clinical-research-team-needs-online-learning-now/): In the current COVID-19 crisis, where research has taken a central focus, and a lot of other studies have been halted. Discover why online learning is now more crucial than ever. - [An Important Message from GCP Central CEO, Marieke Meulemans](https://gcpcentral.com/gcp-central-news/a-message-from-gcp-central-ceo/): The current COVID-19 crisis has many companies changing the way they think and the services they provide. Find out what GCP Central is doing, and discover more about our collaboration with CastorEDC here. - [Your Opinion Matters: Take The myGCP Survey](https://gcpcentral.com/gcp-central-news/your-opinion-matters-take-the-mygcp-survey/): At GCP Central, our commitment is to providing quality training to our users. We appreciate feedback, and use this to improve our learning system, myGCP. After all, one of the most effective ways to learn is to be continuously updated with new knowledge and improve your skills based on this. - [GCP Central Shares Highlights from the European Conference on Clinical Research (EUCROF)](https://gcpcentral.com/gcp-central-news/gcp-central-at-eucrof/): On the 10th and 11th of February, GCP Central (alongside Seuss+) attended the European Conference on Clinical Research (EUCROF) hosted by the European CRO Federation. Representing GCP Central were Marieke Meulemans and Anouk Koers and from Seuss+, Sabine Hutchison, and Kieran Canisius. - [How often should GCP Training be completed?](https://gcpcentral.com/gcp-central-news/how-often-should-gcp-training-be-completed/): There isn’t one piece of current legislation that dictates the answer, and in many cases, this is dictated by the employer or trust. The answer often depends on the type of research your team is involved in and their previous experience. - [Webinar Announcement: Drive better quality clinical research with continuous learning](https://gcpcentral.com/gcp-central-news/webinar-announcement-continuous-learning/): Join Marieke on the 17th of December at 2pm CET for our first-ever live webinar. It's easy to register right here.  - [Are you ready for the European Clinical Trial Regulation (ECTR)? GCP Central launches 5 different ECTR training courses within myGCP](https://gcpcentral.com/gcp-central-news/are-you-ready-for-ectr/): We don’t want you to wait until the last minute for compliance, so we did the hard work to bring more practical and engaging online ECTR training to you. - [Meet The Team: Introducing Saskia](https://gcpcentral.com/gcp-central-news/meet-the-team-introducing-saskia/): Another installment from our popular “Meet the Team” feature, this week we’re catching up with Saskia, who joined GCP Central earlier this year as Content & training manager. Join us as we find out all about Saskia’s role at GCP Central. - [What’s new in myGCP version 2.10?](https://gcpcentral.com/mygcp-software-release/whats-new-in-mygcp-version-2-10/): It’s here! The long-awaited version update of myGCP has arrived. In this blog, we’ll visit all the changes and updates made to myGCP, and what you can expect from it moving forward. - [European Clinical Trial Regulation (ECTR) E-Learning Creates a Long Term Partnership](https://gcpcentral.com/gcp-central-news/ectr-e-learning-partnership/): The implementation of the European Clinical Trials Regulation (ECTR) should be a hot topic at the moment. - [Meet the Team: Introducing Anouk](https://gcpcentral.com/gcp-central-news/meet-the-team-introducing-anouk/): In the latest installment of Meet the Team, Anouk has recently joined GCP Central. We caught up with her and discovered what she's bringing to the team.  - [Meet the Team: Introducing Sharon](https://gcpcentral.com/gcp-central-news/meet-the-team-sharon/): From Australia’s Southern Highlands to the world of GCP training comes our latest GCP Central superstar, Sharon. We sat down with her (with a lot of laughs as well!) to talk more over her new role with the team, and also find out a little bit more about her, and what skills she brings to our amazing team. - [Meet us and find out what we are all about. GCP Central launches brand video](https://gcpcentral.com/gcp-central-news/gcp-central-brand-video/): It’s time to get to know us a little better, so we are proud to announce and share our brand video today. - [What’s new with myGCP? Updates and changes inspired by you](https://gcpcentral.com/mygcp-software-release/whats-new-with-mygcp/): Continuous learning is one of our core values here at GCP Central, and your feedback is so important to us as part of our internal learning loop and platform improvements. We have made several important improvements to myGCP over the past couple of months and am sharing them with you right here. - [Which myGCP link is right for me?](https://gcpcentral.com/gcp-central-products/which-mygcp-link-is-right-for-me/): This year we enthusiastically launched our new brand to the world and have been rolling out myGCP improvements all along with it since then. Part of our improvements was the implementation of two different myGCP environments entry domains. One of which is specifically for the Dutch community and one for the global community. - [A week in the life of CEO Marieke Meulemans](https://gcpcentral.com/gcp-central-news/a-week-in-the-life-of-a-ceo/): So, there you have it - a week in the life of a CEO, and my top tips for staying on top of the workload. Running a business is challenging but highly rewarding, and I hope a peek into my life inspires anyone who's thinking of starting on their own, to go for it! - [The business values that drive GCP Central](https://gcpcentral.com/gcp-central-news/the-business-values-that-drive-gcp-central/): Business values drive the way the organization is set up. As one of our values is to be open for feedback, we have tools implemented to collect that feedback and have a customer service department for direct support via telephone and email. - [myGCP Update: What’s new in version 2.95?](https://gcpcentral.com/mygcp-software-release/whats-new-mygcp-update/): We’re always looking to see what we can do to make improvements here at GCP Central and lately, we’ve been quite busy listening to your feedback and making important changes.  - [How to achieve a new ‘normal’ for sponsors](https://gcpcentral.com/gcp-central-news/how-to-achieve-a-new-normal-for-sponsors/): The relationship between a sponsor company and a CRO has always been a close one. Many smaller sponsor companies heavily rely on the services of CROs to get their products developed. - [The wider impact of relevant GCP Training](https://gcpcentral.com/gcp-central-news/the-wider-impact-of-relevant-gcp-training/): Why is GCP such an important discipline, what impact does it have on clinical trials and why does it’s training need to be relevant and engaging? - [myGCP launches new software release – What’s new?](https://gcpcentral.com/gcp-central-news/mygcp-launches-new-software-release-whats-new/): At the end of March, after months of behind the scenes planning, we finally launched our brand refresh. New branding, color palette, logo, and website has helped us move the business into a new era that matches our new business goals and position. - [The GCP Central brand relaunch](https://gcpcentral.com/gcp-central-news/gcp-central-brand-relaunch/): Earlier this month (after months and months of preparation) we finally relaunched GCP Central with a fresh new look and a brand new website. - [Inside the classroom – GCP Central blended WMO/GCP course in March](https://gcpcentral.com/gcp-central-news/inside-the-classroom/): Join us this week as we catch up with our resident GCP nerd, Eric Klaver . He gives us a sneak peek behind the classroom door of the latest GCP Central WMO/GCP training course held earlier in March. - [Raising the profile – TransCelerate Mutual Recognition Initiative](https://gcpcentral.com/gcp-central-news/raising-the-profile-transcelerate-mutual-recognition-initiative/): In January 2019 we wrote an article about what it means when a training provider claims to have "TransCelerate acknowledged" GCP training. - [Register now for our blended WMO / GCP training course](https://gcpcentral.com/gcp-central-news/register-now-for-our-blended-wmo-gcp-training-course/): Are you looking for a job in clinical research? Then increase your chances on the labor market with a Blended WMO / GCP course. - [Preventing duplicate GCP training – does it work?](https://gcpcentral.com/gcp-central-news/preventing-duplicate-gcp-training-does-it-work/): In the world of Good Clinical Practice, what does it mean when a Training Provider claims to have "TransCelerate acknowledged" GCP training? Our questionnaire shows not many investigators, CRAs and site staff are aware of the existence and added value. - [Mobile Learning: It’s not as difficult as you think](https://gcpcentral.com/gcp-central-products/mobile-learning-its-not-as-difficult-as-you-think/): Mobile learning is in the spotlight, with the demand for fast, interactive and scalable education is on the increase. As we roll into 2019, we take a look at our crucial top trends for mobile learning. - [Lights Camera Action! Behind the GCP Central Photoshoot Scenes](https://gcpcentral.com/gcp-central-news/lights-camera-action-behind-the-gcp-central-photoshoot-scenes/): 2019 will mark some very interesting and exciting changes for GCP Central, we do not want to give too much away just yet the photoshoot marks a new era for us. - [Happy Christmas and a prosperous New Year](https://gcpcentral.com/gcp-central-news/happy-christmas/): From December 22 to January 2 The GCP Central office will be closed, we'll be celebrating Christmas with our families. 2019 will be an exciting year for GCP Central - [5 important reasons to extend your myGCP account](https://gcpcentral.com/gcp-central-news/5-important-reasons-to-extend-your-mygcp-account/): All GCP training is the same, right? After all, it's all about getting that certificate and being "compliant": to tick that box. It is a struggle to keep up with the latest changes and current guidelines. And then before you know it ... It's time to do the same GCP training all over again. - [For us, it’s logical – first the question, then the answer](https://gcpcentral.com/gcp-central-news/first-the-question-then-the-answer/): There are few people that describe GCP training as “fun”. You’re usually bombarded with pages of text to memorize, endless powerpoint presentations and an overwhelming amount of legal articles and phrases to absorb. Probably topped off with a 10 question “test” assuming you have read the information. This kind of GCP training has nothing to do with learning. - [5 reasons why e-learning is the new modern classroom](https://gcpcentral.com/gcp-central-news/5-reasons-why-e-learning-is-the-new-modern-classroom/): Over the last few years, there's a rise in the popularity of online e-learning courses and training. This is not only within the pharmaceutical world but across many different industries.  - [Borderless Training. GCP Central launches internationally](https://gcpcentral.com/gcp-central-news/borderless-training-gcp-central-launches-internationally/): Since the launch of GCP Central back in 2012, we have worked tirelessly towards making GCP a core part of everyday practice for medical, pharmacy and clinical professionals. - [Training day for GCP and WMO for trial medication pharmacists and assistants – 23 November A.S.](https://gcpcentral.com/gcp-central-news/training-day-for-gcp-and-wmo-for-trial-medication-pharmacists-and-assistants-23-november-a-s/): International Good Clinical Practice Guideline (ICH-GCP), EU Directives, Medical Research involving humans Act (WMO) - [ICH training and advice carries activities to GCP Central](https://gcpcentral.com/gcp-central-news/ich-training-and-advice-carries-activities-to-gcp-central/): GCP Central has from 1 June 2017 taken over the GCP training activities fromICH Training and adviceAns and Anjo Strik have been active in training research professionals since 1996, and at that time experienced the creation of ICH-GCP. The knowledge of Anjo and Ans that has been acquired over the past 20 years will not be lost and we will continue to proudly propagate it. - [What is your GCP certificate worth?](https://gcpcentral.com/gcp-central-news/what-is-your-gcp-certificate-worth/): On June 14, 2017 the new ICH GCP is in effect: Addendum R2. In hospitals, pharmaceutical companies and CROs, the agreement has been made that a GCP training certificate obtained is valid for 2 to 4 years. But what if, in the meantime the legislation is updated as in this case? What is the value of your previously obtained GCP certificate? - [Never too much learning about Good Clinical Practice?](https://gcpcentral.com/gcp-central-news/never-too-much-learning-about-good-clinical-practice/): At GCP Central, we believe that it is better for the quality of clinical research, if we do not only actively train research professionals in GCP every 2-4 years, but also in the intervening period. - [Follow master classes by top speakers! GCP Central Spring School of 15-19 may 2017](https://gcpcentral.com/gcp-central-news/follow-master-classes-by-top-speakers-gcp-central-spring-school-of-15-19-may-2017/): This year we are organizing the GCP Central Spring SchoolIn the week of the 15th to the 19th May 2017, we will organize various in-depth sessions and master classes on a level by top speakers. For starters with ambition and for experienced professionals who understand that standstill is decline. Invest in yourself and come to one of the master classes! - [DCRF teams up with GCP Central for online ECTR training](https://gcpcentral.com/gcp-central-news/dcrf-teams-up-with-gcp-central-for-online-ectr-training/): After a careful selection process, the DCRF has entered a partnership with GCP Central for the development and operation of an online training program on the ECTR. The ECTR, which comes into force in October 2018, is the abbreviation for the EU Regulation 536/2014, concerning clinical trials with medicinal products for human use. The regulation aims to simplify and accelerate clinical drug research within the EU. - [WMO/GCP training via your own learning portal? It’s possible](https://gcpcentral.com/gcp-central-news/wmo-gcp-training-via-your-own-learning-portal-its-possible-2/): We at GCP Central are always looking for new ways to doWMO/GCP training in an even more efficient way. For students, this by only teaching them what is relevant at that moment. For research agencies and managers, by providing reports and insight into training compliance. Now we have something new. From today it is possible to offer our online WMO / GCP training courses via the electronic learning portal of the hospital itself. - [WMO/GCP training via your own learning portal? It’s possible](https://gcpcentral.com/gcp-central-news/wmo-gcp-training-via-your-own-learning-portal-its-possible/): We at GCP Central are always looking for new ways to doWMO/GCP training in an even more efficient way. For students, this by only teaching them what is relevant at that moment. For research agencies and managers, by providing reports and insight into training compliance. Now we have something new. From today it is possible to offer our online WMO / GCP training courses via the electronic learning portal of the hospital itself. - [Guidance for the assessment of minors](https://gcpcentral.com/gcp-central-news/guidance-for-the-assessment-of-minors/): Last week, on March 1, 2017, the amended Medical Research Involving Human Subjects Act (WMO) went into effect. The Dutch Association of Medical Ethical Testing Commissions (NVMETC) and the Central Commission of Human-Related Research (CCMO) have written a testing framework to clarify current regulations about which medical ethical review committees (METCs) should assist in the assessment of non-therapeutic research with children and mentally incapacitated adults. This testing framework is naturally also useful as a guide for researchers designing studies. - [Dutch Senate approves bill to expand possibilities for research with minors and incapacitated](https://gcpcentral.com/gcp-central-news/dutch-senate-approves-bill-to-expand-possibilities-for-research-with-minors-and-incapacitated/): Modified from original article on www.CCMO.nl - [We are looking for a GCP training that takes you step by step in research land](https://gcpcentral.com/experiences/we-are-looking-for-a-gcp-training-that-takes-you-step-by-step-in-research-land/): Since January 2016 The Tweesteden hospital and the St. Elisabeth hospital merged to form the Elisabeth-Tweesteden Hospital (ETZ). It is one of the 26 cooperating top clinical hospitals (STZ) in Netherlands. That means extra attention to training and research. Marika Talbert Avenue and Marte Hameed of the Science Desk ETZ, tell about the implementation with regard to GCP training. ## Pages - [Protected: LTI Integration](https://gcpcentral.com/lti-integration/): No extra logins required - [Business Developer](https://gcpcentral.com/business-developer/): GCP Central has been developing online training courses for clinical research for 10 years and is now a market leader in the Netherlands. With our innovative approach to GCP training, we help professionals and organizations master rules and guidelines in an innovative way. Through our learning platform myGCP, we offer an interactive, flexible learning method that is available worldwide. Driven by passion for innovation, we continue to strengthen medical scientific research by listening to customer needs and continuously innovating. Our office is located in Utrecht, the Netherlands.   - [Request a Quote](https://gcpcentral.com/request-a-quote/) - [Refund and Returns Policy](https://gcpcentral.com/refund_returns/): This is a sample page. - [Intern Learning and Development](https://gcpcentral.com/intern-learning-and-development/): The internship is focused on how to write an design content. - [Resources](https://gcpcentral.com/resources/): for you and your company - [Blog & News](https://gcpcentral.com/blog-news/): Annex 2 of ICH E6(R3) has been developed with these changes in mind. Rather than creating a new set of Good Clinical Practice (GCP) principles, it builds on Annex 1 by explaining how existing GCP expectations should be applied. - [Divi SOS Layout Loader](https://gcpcentral.com/divi-sos-layout-loader/): This page is part of the SOS plugin. DO NOT EDIT OR DELETE THIS PAGE. - [Why myGCP Training Courses](https://gcpcentral.com/why-mygcp-training-courses/): myGCP IS AN INNOVATIVE AND MODERN LEARNING SYSTEM - [My account](https://gcpcentral.com/my-account/): Your personal data will be used to support your experience throughout this website, to manage access to your account, and for other purposes described in our privacy policy. - [Checkout](https://gcpcentral.com/checkout/) - [Cart](https://gcpcentral.com/cart/): Your cart is currently empty. Return to shop - [Shop](https://gcpcentral.com/shop/) - [EUCROF Conference](https://gcpcentral.com/eucrof-conference/): Want more information about GCP Central and our training courses, including EU CTR and ICH GCP? Leave your contact details here, and we’ll be back to you after the congress. - [GET A QUOTE](https://gcpcentral.com/get-a-quote/): The goal of myGCP, an online GCP compliance training application, is to ensure your staff is up-to-date and actually excited when they receive Good Clinical Practice knowledge. We believe offering a modern, innovative and continuous way of GCP  and ECTR training propels the trial and data quality of your clinical research to the next level. Request a quote and get started. - [AMC](https://gcpcentral.com/amc/): More informatie - [GCP Compliant](https://gcpcentral.com/gcp-compliant/): The dashboard gives organizations a quick overview of the training progress per participant, the number of certified participants, and the number of active licenses. Handy if you are preparing for an audit or inspection. Contact participants directly, generate reports, and get a quick update on the number of licenses you still have. - [IKNL DATA MANAGEMENT MASTERCLASS](https://gcpcentral.com/iknl-data-management-masterclass/): The Basic & Advanced Data Management masterclass led by Petra Westveer, team leader at the trial bureau of the Netherlands Comprehensive Cancer Organisation (IKNL), is organized in cooperation with GCP Central, the training agency specialized in practically oriented training in Good Clinical Practice and clinical research. - [GCP Update](https://gcpcentral.com/gcp-update/): We'll notify you through myGCP if there are changes to the Good Clinical Practice Guidelines, or other laws and regulations. We'll update the training content, and then send you a notification. You can then go through the modified chapter and answer the questions. Your training level is at 100% again and you are fully up to date without any repetition. - [Recognized Certificate](https://gcpcentral.com/recognized-certificate/): In most hospitals, it is mandatory for the (main) researcher and everyone involved in clinical research to have compliant GCP training. With our online training courses, you’ll receive a recognized GCP certificate. - [Active Learning](https://gcpcentral.com/active-learning/): The GCP training consists of lessons of about 10 minutes. You can easily complete a chapter between your other daily tasks, or on the train ride home. - [Call me back](https://gcpcentral.com/call-back/): NEWSLETTERStay up-to-date with the latest news and myGCP updates - [Which gcp training is right for me](https://gcpcentral.com/which-gcp-training-is-right-for-me/): NEWSLETTERStay up to date with the latest news and myGCP updates here - [Terms and Conditions](https://gcpcentral.com/terms-and-conditions/): 1. GENERAL TERMS AND CONDITIONS1.1 GCP CENTRAL B.V., a company legally constituted under the laws of the Netherlands, registered in the trade register of the Chamber of Commerce under number 55249922 (hereinafter: “GCP CENTRAL”).1.2 GCP CENTRAL is in the business of providing (e-)learning solutions and educational service, including but not limited to online, offline and blended training courses (hereinafter: “PLATFORM”).1.3 These terms and conditions apply to every offer of, agreement with, assignment granted to and/or legal act or service performed by GCP CENTRAL in relation to a counterparty (hereinafter: “COUNTERPARTY”), including every follow-up assignment or altered or supplementary assignment.1.4 These terms and conditions also apply for the benefit of everyone who works or worked at/for GCP CENTRAL (as an independent contractor or as an employee), any person engaged by GCP CENTRAL, including any of their heirs, and all persons for whose acts or omissions GCP CENTRAL is or may be liable.1.5 The applicability of general terms and conditions of COUNTERPARTY is hereby expressly excluded. - [Privacy Policy](https://gcpcentral.com/privacy-policy/): We are GDPR compliant, and respect the privacy of our clients and users. Our full privacy policy statement can be found here https://mygcp.nl/Privacyverklaring_GCP_Central_BV.pdf - [Newsletter](https://gcpcentral.com/newsletter/): We know that every business out there wants you to sign up to their newsletter, but we wanted to share a few reasons why we think you should join the GCP Central community and newsletter. - [Support](https://gcpcentral.com/support/): We believe in fast and efficient customer service, and we’re proud to have our own in-house dedicated support team. We are always on hand to answer questions and queries and give advice and guidance on our training courses. - [Careers](https://gcpcentral.com/careers/): GCP Central has been developing online training courses for clinical research for 10 years and is now a market leader in the Netherlands. With our innovative approach to GCP training, we help professionals and organizations master rules and guidelines in an innovative way. Through our learning platform myGCP, we offer an interactive, flexible learning method that is available worldwide. Driven by passion for innovation, we continue to strengthen medical scientific research by listening to customer needs and continuously innovating. Our office is located in Utrecht, the Netherlands.   - [Stories](https://gcpcentral.com/stories/): SOME OF OUR CUSTOMERS - [Press and Speaking](https://gcpcentral.com/press-and-speaking/): GCP Central CEO and Founder Marieke Meulemans speaks routinely across Europe at industry events, corporations, universities, nonprofits and professional organizations. - [Insights](https://gcpcentral.com/insights/): Aug 4, 2026 | GCP Central News - [Methodology](https://gcpcentral.com/methodology/): We’ve proudly developed the industry-leading SMART™ GCP learning method. This unique approach is helping us change perceptions and the face of GCP Training. - [Contact](https://gcpcentral.com/contact-2/): By Phone+31 85 130 54 89Our customer service is available from Monday to Friday from 8.30 to 17.00 hrs. - [Home](https://gcpcentral.com/): Learn the best way with high-quality, on-demand and self-paced courses - [Accreditation](https://gcpcentral.com/accreditation/): With so many GCP courses available on the market, it's not easy to know which one to choose. - [GCP Training](https://gcpcentral.com/gcp-training/): show blocks helper - [About](https://gcpcentral.com/about/): We are changing the face of GCP training by liberating clinical research professionals and organizations to learn about rules and regulations differently. Through modern learning methods, we free the clinical research industry of death by PowerPoint and text-based e-learning. ## Projects - [Vascular Research Network](https://gcpcentral.com/project/vascular-research-network/): For 20 years, Vascular Research Network (VRN) brings clinical studies to the Netherlands and mediates between pharmacist, vascular internists, and cardiologists. - [Elisabeth-Tweesteden Hospital (ETZ)](https://gcpcentral.com/project/elisabeth-tweesteden-hospital-etz/): In January 2016 The Tweesteden hospital and the St. Elisabeth hospital merged to form the Elisabeth-Tweesteden Hospital (ETZ). ## Products - [ICH GCP R3 Transition Course](https://gcpcentral.com/ich-gcp-r3-transition-course/): This is the self-paced online training solution for all professionals who are involved in the setup and conduct of clinical trials with medicinal products in ICH regions, and need to be aware of the changes to the Good Clinical Practice guideline ICH GCP E6 (R3). This course translates the changes in ICH GCP Guideline to clinical practice and gives you the tools to start implementing the changes in your daily practice and procedures.   Duration 2 hours Language - English With practical insights from experts Easy access on desktop, tablet and mobile Online Exam & Certificate of Completion Highly interactive due to our question-based learning method Flexible: Access the course anytime, anywhere - [MDR for Clinical Research in the Netherlands](https://gcpcentral.com/mdr-for-clinical-research-in-the-netherlands/): This training is the perfect solution for investigators and research professionals involved in clinical trials with medical devices in the Netherlands, who want to understand the requirements for clinical research with medical devices since the introduction of the Medical Device Regulation (MDR). Via the interactive storyline, you will learn about the requirements of the MDR, the CCMO and the ethics committees. And what to report to the IGJ in case of incidents and when.   4 hours Modular and at your own pace 6 modules (The Basics, Scope of MDR, Submitting, Safety Reporting and Modifications, Post-Marketing Follow-Up and Vigilance reporting) Knowledge test with 25 questions Available in Dutch and English Focuses on clinical research in the Netherlands Online certificate with a testscore of 80 or higher - [EU CTR for Drug Research in Europe – Conduct](https://gcpcentral.com/eu-ctr-for-drug-research-in-europe-conduct/): This training gives you the essentials on the EU CTR regulation, as well as an in-depth understanding of how to conduct clinical drug research according to the new EU regulation, such as safety and trial reporting, submitting amendments, and quality control. Learn how to avoid breaches and quality issues, and what to do if they happen, as well as learning how to collaborate effectively.   3,5 hours 2 modules (Introduction, during and after the study) Knowledge test with 20 questions and 3 attempts Available in Dutch and English Focuses on clinical research in Europe Online EU CTR certificate with a testscore of 80 or higher - [MDR for Clinical Research in Europe](https://gcpcentral.com/mdr-course-for-clinical-research-in-europe/): This is the perfect training solution for investigators and research professionals involved in clinical trials with medical devices in Europe, who need to know what has changed since the MDR is in force.   4 hours Modular and at your own pace 6 modules (The Basics, Scope of MDR, Submitting, Safety Reporting and Modifications, Post-Marketing Follow-Up and Vigilance reporting) Knowledge test with 25 questions Available in Dutch and English Focuses on clinical research in Europe Online certificate with a test score of 80 or higher - [VGO](https://gcpcentral.com/vgo/): This online course teaches you what you need to know about the new procedure for local feasibility and the Site Suitability Declaration (VGO). The interactive and self-paced online training is developed in co-creation with the DCRF Local Feasibility Working Group. 1,5 hours 1 module (VGO) Knowledge test with 8 questions Available in Dutch and English Focuses on clinical trials in The Netherlands Proof of completion Efficient and interactive online learning Easily accessible via smartphone, tablet or desktop Modular learning at your own pace This online training has been developed in close collaboration with the DCRF Working Group Local Feasibility with contributions from experts from STZ hospitals, UMCs, general hospitals, pharmaceutical companies, CROs and Platform Researchers Networks. - [ICH GCP for Sites in International Clinical Research](https://gcpcentral.com/ich-gcp-for-sites-in-international-clinical-research/): The expert course to ICH GCP for Sites is the self-paced online training solution for clinical research professionals who lead and conduct international clinical trials in sites in ICH regions, and need to be aware of the sites responsibilities as laid down in Chapter 4 of the Good Clinical Practice guideline applicable to clinical research with study participants.   4 hours 6 modules (Introduction, trial setup, preparation, submission, conduct and close-out) Knowledge test with 25 questions and 3 attempts Available in English Transcelerate acknowledged Acknowledged GCP certificate Focuses on International clinical research from a sites perspective Efficient and interactive learning Easy accessible via smartphone, tablet or desktop Self-paced and modular - [GMP Quality Oversight for European Drugs](https://gcpcentral.com/gmp-quality-oversight-for-european-drugs/): This is the self-paced online training solution for GMP quality professionals who are responsible for quality oversight of pharmaceutical contract manufacturing and need to be aware of the GMP requirements as laid down in ICH Q9, Q10 and EU-GMP Guide including the Annexes. It ensures awareness and understanding how a quality system is set up in an outsourced model. 3 hours 3 modules (Introduction, Quality Oversight, Distribution) Available in Engllish Online GMP certificate Practice-based and interactive learning Easy accessible via smartphone, tablet or desktop Self-paced and modular This course has been developed in collaboration with Quality Oversight experts and translates the GMP framework to practice. It gives you the tools and examples to directly implement the knowledge in your daily practice. - [ICH GCP for Sponsors in International Clinical Research](https://gcpcentral.com/ich-gcp-for-sponsors-in-international-clinical-research/): This is a self-paced online training solution for clinical research professionals who initiate and monitor international clinical trials in ICH regions, and need to be aware of the sponsor responsibilities as laid down in Chapter 5 of the Good Clinical Practice guidelines applicable to clinical research with study participants .   4 hours 6 modules (Introduction, trial setup, preparation, submission, conduct and close-out) Knowledge test with 25 questions and 3 attempts Available in English Acknowledged GCP certificate Foccused on International clinical research from a sponsors perspective Efficient and interactive learning Easy accessible via smartphone, tablet or desktop Self-paced and modular - [CFR for Clinical Research in the USA](https://gcpcentral.com/cfr-for-clinical-research-in-the-usa/): Learn about the principles the Code of Federal Regulations (CFR) add to the ICH GCP expectations and get a detailed understanding of the knowledge required for clinical research in the USA. 3 hours 1 online module, including 7 chapters Available in English Online certificate Highly interactive Written by CFR experts FDA-focused training Including expert interviews Including practical case scenarios & handy tools Unique addition to your ICH GCP knowledge (*prerequisite) Our CFR online course for clinical research in the USA is ideal for individuals involved in the setup and conduct of clinical (drug) trials in the USA, who need to learn about the additional requirements by the FDA. - [EU CTR for Drug Research in Europe](https://gcpcentral.com/eu-ctr-for-drug-research-in-europe/): Our all inclusive EU CTR training helps you understand all the vital aspects of the EU CTR regulation. You’ll learn all strategic elements, from study design, to submission, to clinical conduct in our course, making you the EU CTR expert. This course teaches you everything you need to know about this regulation, and you’ll walk away with a complete deep dive into EU CTR regulation.   6,5 hours 4 modules (Basis, preparing for a submission, submitting and assessing, during and after the study) Knowledge test with 40 questions Available in Dutch and English Focuses on clinical research in Europe conducted in Europe Online EU CTR certificate with a testscore of 80 or higher - [GCP-WMO for Clinical Research in the Netherlands](https://gcpcentral.com/online-wmo-gcp-course-2024/): The training of choice for researchers, CRA’s, and research nurses. This training is the solution for research professionals who like to learn in a flexible way. The training has been completely revised and meets the requirements set by EMWO in "Toetsmatrijs' version 01-04-2025 and the requirements of Transcelerate BioPharma. The training covers the International Good Clinical Practice guideline (ICH GCP) R3, European legislation EU CTR (drug research) and MDR (medical device research), Medical Research Involving Human Subjects Act (WMO), the Privacy Act (GDPR) and rules for non-WMO research.   Course duration 12 hours 7 modules (Conducting research, Conducting clinical research, Design of the study, Submission and review, Start of research, Clinical conduct and End of trial) Knowledge test with 40 questions - 80% or higher to pass Available in Dutch and English Accreditation GAIA (3 accreditation points), V&VN (12 accreditation points), VSR (12 accreditation points) Focuses on clinical research in The Netherlands Online certificate Preparation for EMWO examination - [GCP-WMO Re-certification](https://gcpcentral.com/gcp-wmo-re-certification/): Do you have a current registration in the GCP-WMO register of EMWO which expires shortly? Extend your registration in the GCP-WMO register using this training. This course is applicable to experienced researchers and research professionals.   3 hours 1 module Knowledge test with 20 questions and 3 attempts Course only available in Dutch Accreditation Online certificate Acknowledged by Academic hospitals, STZ teaching hospitals and EMWO - [GCP-WMO for Clinical Research in the Netherlands – Start and Conduct](https://gcpcentral.com/gcp-wmo-for-clinical-research-in-the-netherlands-start-and-conduct/): This training is your fully revamped online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP research in the Netherlands. The training provides knowledge of the basic principles of Good Clinical Practice (GCP), ICH GCP R3, recruitment of study participants, the informed consent process, safety & medical care to study participants, documentation, data management and privacy of medical/research data.   5 hours 3 modules (Clinical Research, Start and Conduct) Knowledge test with 15 questions - 80% or higher to pass Available in Dutch and English Accreditation GAIA (1,5 accreditation points), VSR (7 accreditation points), V&VN (7 accreditation points) Focuses on clinical research in the Netherlands Online certificate - [GCP-WMO for Clinical Research in the Netherlands – Conduct](https://gcpcentral.com/gcp-wmo-for-clinical-research-in-the-netherlands-conduct/): The training has been completely updated and is your online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in Medical Scientific WMO GCP research in the Netherlands. This training provides knowledge of the basic principles of conducting research, explains the principles of Good Clinical Practice (GCP), ICH GCP R3, safety and medical care to study participants, documentation and data management of research.   3 hours 2 modules (Clinical Research and Conduct of Trials) Knowledgetest with 8 questions - 80% or higher to pass Available in Dutch and English Accreditation GAIA (1,5 accreditation points), VSR (6 accreditation points), V&VN (6 accreditation points) Focuses on clinical research in the Netherlands Online certificate - [GCP-WMO for Clinical Research in the Netherlands – Start](https://gcpcentral.com/gcp-wmo-for-clinical-research-in-the-netherlands-start/): This training is your fully revamped, an online introduction in clinical research. An entry level course, applicable for students and site staff that conduct some tasks in GCP research in the Netherlands. The Introductory training with module Start provides knowledge of the basic principles of Good Clinical Practice (GCP), ICH GCP R3, recruit and inform study participants, the informed consent process and privacy of medical and research data.   3 hours 2 modules (Introduction and Start) Knowledgetest with 8 questions - 80% or higher to pass Available in Dutch and English Accreditation GAIA (1 accreditation point), V&VN (4 accreditation point), VSR (4 accreditation point) Focuses on clinical research in the Netherlands Online certificate