PowerPoint Presentation

[Virtual Presenter] This slide gives an overview of our platform's Product Tutorials. Discover how our platform can help you to manage the entire imaging workflow for the TYR-219-01 study, which includes self-training on imaging, training validation, technical qualification, and communication with Keosys..

TABLE OF CONTENT. 2. INTRODUCTION INVESTIGATIONAL SITES QUALIFICATION IMAGYS PLATFORM COMMUNICATION WITH KEOSYS TAKE-HOME MESSAGES.

INTRODUCTION.

[Audio] The Imagys platform is web-based and used to manage the imaging workflow for the TYR-219-01 study. It is designed to make the imaging process simpler, more rapid, and more secure. It facilitates easier sharing of images, quicker viewing of results, and streamlined data collection. Moreover, it facilitates upholding of high standards of quality and dependability of results. Furthermore, it assists in ensuring the integrity and correctness of the study's data..

[Audio] For the TYR-219-01 study, a structured process should be implemented to evaluate the qualifications of investigational sites. This process should include a comprehensive evaluation of the site's capabilities, qualifications, and history. In addition, any identified deficiencies should be assessed to determine any associated risks..

IMAGING QUALIFICATION. PROACTIF Study. - 6 -. Site contact details provided to Keosys.

[Audio] As you navigate the Imagys platform, it is important to note the Image Acquisition Guidelines. These guidelines will help you ensure that you are producing images of optimal quality, from subject position to scanner parameters. The Imagys User Guide is an invaluable resource that will provide detailed information on how to use the platform - from scan upload to query answer..

[Audio] Staff responsible for image upload and validation must inform Keosys of any changes, upload the images and validate the forms within five working days. Following this, they are expected to reply to any queries within five additional working days..

[Audio] The IMAGYS platform is a powerful tool that allows you to obtain quick results. It is equipped with a wide range of features and tools that make it easy to work with. From managing and analyzing data to creating reports and visualizations, IMAGYS platform can truly revolutionize the way you work. Take advantage of its intuitive interface to make the most out of its capabilities. Leverage its comprehensive features to maximize efficiency and discover the true power of IMAGYS platform..

[Audio] Head to the URL provided to access the Imagys platform. Enter the credentials sent to you via email. Choose a password that is at least 8 characters long and made up of only letters and/or digits. Remember to update the password every 90 days..

[Audio] If you need to reset your login information to the Imagys platform, simply click on the 'Lost password' option on the homepage. Input your ID and email address when prompted and you will be able to reset your password swiftly..

[Audio] Clicking on your name gives you access to a variety of options. You can find settings, account information, and training materials on this platform. Make the most of your TYR-219-01 study by taking advantage of all the features Imagys has to offer..

[Audio] We will be looking at the selection of scans to be uploaded into the Imagys platform, alongside the automatic de-identification of subjects' personal information. Additionally, we will be examining how the Imagys Connector Application can help to streamline the scanning process. Shall we begin?.

[Audio] Once Imagys is installed, any connection to your device afterwards will start the Imagys Connector automatically. Do not close the Imagys Connector webpage, or else any further uploads will be stopped..

[Audio] To create a new patient in the Imagys platform as an Investigator user, simply click on “New patient” and fill in the required information. After completing the process, you can start enjoying the features and benefits Imagys offers..

[Audio] Select a visit from the dropdown list and click 'Add' to create a new patient visit using the Imagys Platform..

[Audio] Select the patient and the visit, then click on "New Series" to upload a new exam. This will open a new tab from the Imagys Connector webpage, where you can view the expected modalities. For more info on the imaging schedule, click on the "here" link..

[Audio] Select the folder containing DICOM images only; compressed folders are not accepted. Once you have selected the folder, click on 'Continue' to gain access to additional information and study documentation..

[Audio] Ensure that the series chosen comply with the study requirements. Afterward, click the "Add series" button to add any additional series. For each series, click the "Series description" button to view its description and then select the series you'd like to upload. Finally, click the "Upload" button to confirm your choices. Completing these steps will guarantee that all series used for the study are uploaded properly..

[Audio] The series will be uploaded to Imagys platform. You can track your global upload progress at the top of the screen, as well as check the progress of each individual series. Before uploading, each series will be de-identified, compressed and uploaded..

[Audio] Once the upload is finished, Imagys Connector will notify you that you may close the webpage. You will receive a summary with the number of series uploaded and not uploaded, making it possible for you to check the series descriptions if it is required. To finish your session, press 'Close the Session' which will redirect you to Imagys. In case you have doubts or require help, you can press 'Help' at any time..

[Audio] Using Imagys Connector, it is simple to upload series to your Imagys platform. After refreshing the page, all uploaded series can be seen. To upload more series, click on "New Series" to open a new Imagys Connector webpage. After uploading, complete the Data Transmittal Form and click submit. Your credentials are needed to validate this form..

[Audio] Investigators can now take advantage of Imagy's platform to easily access and manage all of their study information. Through the platform, investigators can fill and submit the transmittal form for each patient and track the number of screening and treatment visits. MRI and CT scans are also mandatory as part of the study requirements. If a MRI scan is contraindicated for any reason, the comments section must be filled out before the form can be submitted..

[Audio] In the "Comments" section of the Investigator user's transmittal form, it is important to fill out when the answer to the "MRI contraindicated" item is "No". Additionally, screening and treatment visits, as well as PET/CT scans, are also required to complete the form..

[Audio] When creating treatment visits, you may have to describe occasions where the visit was not done. In these cases, you should select the “Not done” option. To ensure the investigator can properly assess the situation, it is mandatory to explain the reason for not performing the visit in the “Comments” section. This helps the investigator evaluate the collected data and assess any consequences which might have arisen due to the missing visit..

26. IMAGYS PLATFORM. Investigator users – Query process.

[Audio] Investigator users can use the Imagys platform query interface to quickly and easily answer any query. This interface provides guidance and instructions on how to answer the query, and what actions are needed to resolve the query..

[Audio] Investigator users must electronically sign each form they validate to confirm the data is correct. Electronic signatures are essential to preserve the integrity of the study. Each signature is timestamped and stored securely with other records..

[Audio] Notifications on the Imagys platform are key to staying up-to-date on the most important events. Every time a form is validated, Imagys will send a notification. When the transmittal form and the quality control form are both validated, users on sites will receive notifications to let them know if the visit was accepted, if a query was raised, or if the visit was rejected. Pay close attention to these notifications to stay informed about the progress of projects..

COMMUNICATION WITH KEOSYS.

[Audio] If you need assistance when using the IMAGYS platform, you can use our chat tool integrated to the platform, reach us via email at [email protected], or contact Léo Piquet at [email protected], the project manager of the TYR-219-01 study. Our study coordinator Quentin Craveiro is also available at [email protected]. Alternatively, you can call us on +33 6 52 66 91 18..

TAKE-HOME MESSAGES.

[Audio] Adhering to the study requirements when uploading images to the Imagys platform is essential. Furthermore, familiarizing yourself with the image acquisition guidelines is also crucial to make sure the images are captured correctly. Queries can be answered within five working days and images can be acquired within five working days after they have been uploaded..