AGAH – Applied Course in Data Management (2 halbe Nachmittage)
digitale Veranstaltung/digital event,
Also in early phase trials the ultimate goal of Clinical Data Management is to assure that data structure, data collection and quality as well as data analysis adequately support conclusions to be drawn from clinical research. In the end high-quality data should be accurate, suitable for statistical analysis and the structure should follow internationally accepted standards. Quality by design in clinical data management means a structured interplay of all relevant core documents including the trial protocol, CRF, DMP/DVP/SAP as well as the data base itself. How to ensure this in early clinical development?
This workshop gives an introduction into the basic principles of clinical data management starting from the trial protocol and ending with the completed data base. Participants will train the knowledge communicated in a practical example together with an experienced team of data managers.
Furthermore, the workshop will offer a first insight into CDISC principles, how this helps to systematically reach a high-quality data structure and in how far this is of rele-vance for submission procedures.
Who should attend?
The workshop has been developed for clinical investigators, project leaders and project managers, monitors and also for phase-I/II experienced study nurses with a certain enthusiasm for data structures who want to better understand the principles of a good-quality data management and how
they can contribute already in the planning phase to set-up a data structure following international principles. It covers questions relevant for industry-sponsored studies as well as IITs.
What access data do I need on the day of the Course?
Two weeks before the event (18 May 2021), you will receive two separate messages with your personal access data. You can already try them at our appointments for technical check1
How to download the necessary browsers and application?
Google Chrome: https://www.google.de/intl/de/chrome/
Microsoft Edge: https://www.microsoft.com/de-de/edge
Microsoft Teams: https://www.microsoft.com/en-gb/microsoft-teams/download-app
How do I log in?
After your registration (and finalized payment) you will receive your personal account information to access the Course.
I already have a Microsoft Teams account and use the app on my computer or laptop
1.1. please log out of this Team account (top right, click on your profile picture – round circle, at the bottom: “log out”)
1.2. register again with the access data from the message you received from us. The login interface will look like this (click to view)
2.1. please download and install the app first (highly recommended!)
2.2. for Desktop: https://www.microsoft.com/en-gb/microsoft-teams/download-app
2.3. continue with 1.2.
2.4. on the mobile device: download and install the App from Google Play (Android) or App Store (iPhone/iPad)
2.5. continue with 1.2.
- Microsoft Teams can also be used directly on the web without an app download* (note: you cannot use the web app on your mobile device!)
The login interface will look like this (click to view)
3.2. continue with 1.2
*Maybe your browser asks if it is ok if “MS Teams“ use your microphone and camera. To be seen and heard in the course, you have to allow this. You will also be asked to verify your login information. Confirm them and select a pre-set verification.
1Appointments for technical check (please use your account data to login)
We kindly invite you to our test meetings – please join us:
20 May 2021 | 10:00-11:00 AM or
20 May 2021 | 15:00-16:00 PM
What are the technical requirements for participation in the web seminar?
To participate, you need an internet-enabled device, access to stable internet and either one of these two web browsers, Google Chrome (click) or Microsoft Edge (click) or the respective app of the video conferencing platform Microsoft Teams. The use of Internet Explorer or Safari as browsers cannot be recommended. It is advisable to use a laptop or desktop computer, as this ensures the best possible display. The use of a mobile device (phone, tablet) is also supported by the software. Please ensure that your internet connection reaches 2 MB/s upload and 4MB/s download. You can test your internet connection here. Please check that your speaker box and sound work well and that you can be heard well for a discussion session. You will achieve the best quality by using headphones with a microphone (headset).
How can I ask questions to the speakers?
In case of a question, please “raise your hand” and turn on your microphone if the speaker addresses you. You may also write your question(s) in the chat. There will be enough time for questions and discussions within the programme.
How do I get a certificate of participation?
Upon request, we will gladly send you a certificate of attendance. Please indicate this request after the course via the feedback message.