myTI
Q.1. Is the mobile application a native mobile App that needs to be downloaded from either the Apple Store or Google Play? Or is it web-based?
Answer: The mobile application is a native app and needs to be downloaded from the respective app store.
Q.2. How are the login credentials managed for the mobile App?
Answer: The credential management process is same as that for the rest of Trial Interactive.
Q.3. Is myTI 21CRF Part 11 Compliant?
Answer: Yes
- Audit Trails - Need to understand what records are auditable and where we will find these records (e.g. take a picture, and send it to eTMF)
- Electronic Records – what records are subject to audit trails records are subject to an audit trail and are maintained in TI. The myTI uses the same APIs as TI. The app is a window to the same functionality that exists in TI.
- Electronic Signatures – are e-signatures (equivalent of wet ink) being used anywhere or is there only an electronic approval process with True Copy Certification and with e-signature document approvals (IF room has TI signature AND user has been assigned to need e-signature for a document approval step).
Q.4. Can DocuSign and AdobeSign be used for signatures with myTI?
Answer: No. With myTI the 'TI Signature' is the only signature tool that can be used for Certified Copy Submission or Document E-Signature (for approval).
Q.5. After a picture has been taken, can you redact the document before uploading it?
Answer: No, but the document can be redacted once in TI using the built-in redaction tools.
Q.6. Are pictures allowed to be taken while in “Offline Mode”? If so, how are images protected while held in local storage?
Answer: While in offline mode, images are encrypted and held in the app’s memory only (while queued and waiting for the transfer to the server). The only local storage is in the memory within the app. The user has to log into the app to be able to access the images prior to submission back to the TMF. The images are not accessible from any other way within the mobile device.
Q.7. In standard mode (Online), are pictures held in common RAM (as opposed to NVRAM)?
Answer: Images are held in RAM in both online and offline mode.
Q.8. Are any checks made to verify that a mobile device has not been compromised?
Answer: An authentication token is required by the API for every call, it is not cached, and static API keys are not used. The apps are signed and registered for app authenticity along with Device Check and SafetyNet for device authenticity.
Q.9. If a mobile device has been compromised, how does the app protect study data?
Answer: Offline mode is the only time data is stored within the app. Offline mode requires biometric authentication to be able to log into the app. The encrypted data stored within the app cannot be accessed outside of the app. Each new session of the app requires authentication, similar to your bank app.
Q.10. Does the app use any form of encryption to protect local information?
Answer: Yes, all images are encrypted locally in RAM.256-bit AES Encrypted.
Q.11. What devices is myTI built for?
Answer: The MyTI application is built iOS and Android, and Google Pixel.
Q.12. How many pages/documents can it upload at a time?
Answer: There is no limit to how many can pages be uploaded at once.
Q.13. Can it take images in color and black/white?
Answer: Yes.
Q.14. Can myTI able to be used on tablets?
Answer: Yes.
Q.15. How does myTI work with TI eTMF?
Answer: myTI is an extension of Trial Interactive.
Q.16. Who is it made for?
Answer: Through v1.3 focus in on the CRA user.
Q.17. Can you submit images without putting in the required fields?
Answer: This is something currently being worked upon. Currently, it is necessary to fill out all required metadata fields before submitting a document.
Q.18. Do mobile uploads convert the documents to PDF?
Answer: Yes.
Q.19. Are the scanned pages/documents validated as they're uploaded into the eTMF?
Answer: No, just because your picture is uploaded does not mean it's validated; it needs to go through a QC process.
Q.20. What software is used for document capture and uploaded to eTMF?
Answer: Scanbot.
Q.21. How does the naming convention work for documents being uploaded into the eTMF?
Answer: The submitted name will be associated with the document type selected.
Q.22. How do we ensure our user can't log in to myTI?
Answer: As part of the implementation process of myTI, a company code is created and configured to the TI eTMF Client Server. Without the creation and configuration of this company code, there is no way for a client to utilize the myTI application. Users can download the application from the App Store or Google Play Store, but will not have access further.
Q.23. What versions of phones the app is built for?
Answer: The MyTI app is built for the following versions.
- iOS 10.3.3 and higher
- iPhone 5 and higher.
- Android 8 Oreo and higher.
Q.24. How do I download myTI?
Answer: From the App Store or Google Play Store. Once downloaded, the application will ask for the company code linked to your TI instance.
Q.25. Can myTI be installed through MDM and VPP?
Answer: Yes, the app can be distributed through an internal MDM solution or the Apple VPP. Custom apps and bundle IDs can be requested but require a separate contract.
Q.26. What version of Trial Interactive does the client need to be on for myTI?
Answer: At least 9.2.7 for v1.2 and higher.
Q.27. How often will new features come out?
Answer: New features are released regularly, following an agile methodology.
Q.28. Can I log into myTI from a personal phone?
Answer: Yes. MyTI can be accessed with your Trial Interactive company code and login credentials.
Q.29. Can I take screenshots? Is there a way to be notified if a screenshot is taken?
Answer: You cannot upload screenshots but can take them to email support from the app.
Q.30. What's the flow of data from mobile to TI?
Answer: Documents captured in myTI are directly submitted to the eTMF and can be previewed on a device or computer. Nothing is stored on the device.
Q.31. Can I see the other CRAs working on this study/at this site?
Answer: Yes, CRAs assigned to a site can view all documents submitted by other users at that site.
Q.32. Is OCR used? If yes, does OCR straighten the documents?
Answer: Not at this time; this is being considered for future versions of myTI.
Q.33. What if characters change in a document during upload?
Answer: Run OCR and verify the document hasn't changed.
Q.34. Who has access to the documents/pages after they're captured on mobile?
Answer: Access is based on the same security settings as in TI.
Q.35. What is the DPI for myTI?
Answer: Documents are captured at a minimum of 300 DPI as per FDA requirements.
Q.36. Is the app localized? If so, where?
Answer: Yes, with localization available for fr_DE, it_IT, de_DE, es_ES, ja_JP, ko_KR, zh_CN, ru_RU, pt_BR, tr_TR, es_LA, he_IL, and uk_UA.
Q.37. How and where is the data stored?
Answer: No documents or images are stored on the device. They are temporarily stored in the app's memory and uploaded upon submission. For offline mode, images remain in the app's memory until submission.
Q.38. What is Mixpanel?
Answer: Mixpanel is a third-party tool that tracks user behavior to improve the product experience.
Q.39. Will the app work with Windows Surface Tablet?
Answer: No, as the scanning technology used lacks an SDK for Microsoft. However, the app works if an Android emulator is used.
Q.40. Are there any configurations needed on the eTMF side?
Answer: Yes, the following needs to be configured.
- Enabling the room for myTI.
- Adding myTI users to the myTI group.
- Assigning CRAs to sites and giving them Editor roles.
- Assigning CRA Reconciliation tasks for CRAs performing reconciliation.
- Avoiding the use of 'submitted name' in the generated name if configured.
Q.41. Does editing scanned documents (e.g., changing lightness or contrast) affect compliance with FDA regulations or audit trails?
Answer: Editing scans for lightness or contrast does not affect compliance with FDA regulations as long as the original scan meets the minimum resolution requirement of 300 DPI. These adjustments do not alter the DPI or the content of the document and do not appear on an audit trail.
Q.42. Are there any countries where myTI cannot be used?
Answer: No, myTI is available in all countries. For example, clients in China are actively using it, demonstrating its global availability.
Q.43. Can the text or criteria for confirming a certified copy be changed?
Answer: Yes, starting from version 1.4, the certified copy text can be customized based on company code preferences.
Q.44. How does the language setting work in myTI?
Answer: The language setting in myTI matches the language of the users device, not the eTMF. If the "Use System Language" option is enabled, myTI will display translations based on the device's language. Currently, myTI supports 11 local languages:
- German
- French
- Italian
- Hebrew
- Japanese
- Korean
- Portuguese
- Russian
- Turkish
- Chinese
- Spanish
Q.45. How can users link myTI to the latest eTMF demo rooms?
Answer: To enable a room for myTI in the TI Demo environment, the Company Code for the Sandbox Environment is "Sandbox." Set up for the company code should be completed by September 4. To enable a room:
- An SA or helpdesk request can enable it.
- Add editor users to the myTI group.
- Assign them to a site as a CRA.
Q.46. Is the data or the documents are stored on the device when using myTI?
Answer: No, nothing is stored permanently on the device. Documents are temporarily cached in encrypted memory within myTI during upload to the Trial Interactive eTMF. If a connection is lost, the documents remain securely cached until reconnected. Once uploaded, the cache is cleared.
Make cache duration configurable by clients, with options ranging from zero (no cache) to 24 hours is in planning stage. The default setting will be 12 hours, and caching will ideally occur in RAM only, ensuring maximum security.
Q.47. What is the purpose of a Company Code in myTI?
Answer: A Company Code is used for all studies and is based on company standards defined by user preferences. When creating a Company Code, configurations such as Light/Full submission, true certification or simple confirmation, biometrics, etc., are determined and applied to all studies with myTI enabled.
Q.48. How are app updates managed for myTI?
Answer: App updates are controlled by the development team, and users are required to update only when necessary. Clients are informated if a forced upgrade is required. Such upgrades may be triggered by updates in TI that affect myTI integration.
Q.49. Does MyTI store data or documents locally on the device?
Answer: Documents and data are temporarily cached on the device during the upload process to the server. However, they are not stored permanently. The cache may be disabled if required.
Q.50. How long are documents and data cached on the device?
Answer: Documents and data are cached for up to 12 hours by default (configurable between 0 to 24 hours), ideally in RAM only. They are deleted as soon as they are successfully uploaded to the Trial Interactive eTMF service.
Q.51. Can MyTI be used when offline? How does offline mode ensure data security?
Answer: Yes, MyTI can be used offline, provided Biometric Authentication is enabled. Key details include:
- Images taken offline are stored in encrypted memory until an internet connection is available.
- Users must reauthenticate via credentials or biometrics to upload documents captured offline.
- Documents remain encrypted in the local cache while attempting to upload to the server.
- Data security is ensured as documents are encrypted at all times and are not accessible while the phone is powered on. They disappear from transient memory once the phone is powered off.
- MyTI remains 21 CFR Part 11 compliant during offline operations.
- Documents can only be coded or submitted when connected to Wi-Fi or cellular data.
- Clients cannot opt out of allowing their users to use myTI offline.
Q.52. What happens to documents if the device loses internet connectivity during transfer?
Answer: If the device loses connectivity during document transfer, the documents are temporarily cached and remain encrypted until the connection is restored, allowing the upload process to complete.
Q.53. How does MyTI ensure data is securely transferred only to Trial Interactive?
Answer: All documents are encrypted during transfer, and operational app data is encrypted at all times. The app prevents any access to cached documents while the phone is powered on. Once the phone is powered off, the documents are erased from transient memory.
Q.54. Is myTI compliant with data privacy and security regulations?
Answer: Yes. MyTI is fully secure and 21 CFR Part 11 Compliant. The myTI Cloud hosting environment complies with regulatory standards for encrypted eTMF document storage. Temporary caching of data is optional and can be disabled based on client preferences.
Q.55. Does editing scans (e.g., changing lightness or contrast) affect compliance with FDA regulations or audit trails?
Answer: Editing scans for lightness or contrast does not affect compliance with FDA regulations as long as the original scan meets the minimum resolution requirement of 300 DPI. These adjustments do not alter the DPI or the content of the document and do not appear on an audit trail.
Q.56. Are there any countries where MyTI cannot be used?
Answer: No, myTI is available globally. For example, clients in China are actively using it, demonstrating its global availability.
Q.57. Can the text or criteria for confirming a certified copy be changed?
Answer: Yes, starting from version 1.4, the certified copy text can be customized based on company code preferences.
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