myTI FAQs

1. Is the mobile application a native mobile App that needs to be downloaded from either 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.

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.

FAQs for myTI

1. Is myTI validated?
   Yes it is validated
2. Is myTI 21CRF Part 11 Compliant?
   Yes
3. Audit Trails - Need to understand what records are auditable and where we will find these records (e.g. take a picture, send to eTMF)
   Electronic Records – what records are subject to audit trails
   All records are subject to audit trail and are maintained in TI. myTI uses the same APIs as TI. The app is a window to same functionality that exist in TI.
4. Electronic Signatures – are e-signatures (equivalent of wet ink) being used anywhere or is there only an electronic approval process
   Used 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)
5. Can DocuSign and AdobeSign be used for signatures with myTI?
   No with myTI 'TI Signature' is the only signature tool that can be used for Certified copy submission or Document E-Signature (for approval)
6. After a picture has been taken, can you redact the document before uploading?
   No, but the document can be redacted once in TI using the built-in redaction tools.
7. Are pictures allowed to be taken while in “Offline Mode”? If so, how are images protected while held in local storage?
   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.
8. In standard mode (Online), are pictures held in common RAM (as opposed to NVRAM)?
   Images are held in RAM in both online and offline mode.
9. Are any checks made to verify that a mobile device has not been compromised?
   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 DeviceCheck and SafetyNet for device authenticity.
10. If a mobile device has been compromised, how does the app protect study data?
    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.
11. Does the app use any form of encryption to protect local information?
    Yes, all images are encrypted locally in RAM.
    256-bit AES Encrypted. The FBI cannot hack this!
12. What devices is myTI built for?
    iOS and Android, even Google Pixel
13. How many pages/documents can it upload at a time?
    There is no limit to how many can be uploaded at once
14. Can it take images in color and black and white?
    Yes
15. Is myTI able to be used on tablets?
    Yes
16. How does myTI work with TI eTMF?
    myTI is an extension of Trial Interactive
17. Who is it made for?
    Thru v1.3 focus in on the CRA user
18. Can you submit images without putting in required fields?
    This is something we're working on. Currently you have to fill out all required metadata fields before submitting a document

1. Do mobile uploads convert the documents to PDF?
   Yes
2. Are the scanned pages/documents validated as they're uploaded into the eTMF?
   No, just because your picture is uploaded does not mean it's validated... needs to go through a QC process...
3. What software is used for document capture and uploaded to eTMF?
   Scanbot?
4. How does the naming convention work for documents being uploaded into the eTMF?
   Submitted name will be associate with the document type selected
5. How do we ensure our user can't login into myTI ?
   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 will be able to download the application from the App Store or Google Play Store, but will not have access further.
6. What versions of phone(s) is it built for?
   • iOS 10.3.3 and higher, Iphone 5 and higher
   • Android 8 Oreo and highe
7. How do I download myTI?
   From the app store or Google play store
   https://itunes.apple.com/us/app/myti/id1329792134?mt=8

   https://play.google.com/store/apps/details?id=com.transperfect.ti.myti&hl=en_US

Once you download the application, it will ask for the company code which is linked to your TI instance.

The myTI application may be installed by individual users, if policy permits, on their own devices my accessing the Apple App or Google Play stores.

1. MDM and VPP

Additionally, if customers would like to install the app using their own internal MDM (Mobile Device Management) solution, TransPerfect can make the iOS app available through the Apple VPP (Volume Pricing Program) for central distribution without impacting bundle IDs and licenses. Customers may request their own app and bundle/app ID, but this will require a separate contract, as the product uses separate 3rd party licenses that must be purchased

1. What version of Trial Interactive does the client have to be on in order to have myTI?
2. At least 9.2.7 for v1.2 and up

1. How often will new features come out?

   We work in an agile methodology and are constantly improving the application for you.

2. Can I log into myTI from a personal phone?

   Yes, you can download myTI and enter using your Trial Interactive company code and login credentials

3. Can I take screen shots? - is there a way for us to be notified if a screen shot was taken?

   No you cannot take screenshots to upload, you can take screenshots to email support from app.

4. What's the flow of data from mobile to TI?

   Documents are captured in myTI and upon submission directly lands in the eTMF which can be previewed on a device or from your computer. Nothing is stored on the device.

5. Can I see the other CRAs working on this study/at this site?
   Yes CRAs assigned to a site in TI can view all document submitted by other users at that site
6. Is OCR used? Does OCR straighten the documents?
   Not at this time, this is something we're looking into for future versions of myTI
7. What if characters change of document as its uploaded.... Run OCR and verify the doc didn't change.
8. Who has access to the document/pages after they're captured on mobile?
   Based on same security as set in TI
9. Whats the dpi for myTI?
   FDA says documents need to be captured in atleast 300 dpi
10. Are we localized? When and where?
    Yes we have localization, fr_DE, it_IT, de_DE, es_ES, ja_JP, ko_KR, zh_CN, ru_RU, pt_BR (please confirm), tr_TR, es_LA, he_IL, uk_UA
11. How/Where is the data stored?
    With using myTI, no documents or images are stored on the device. They are temporarily stored within the applications memory and upon submission immediately uploaded to TI.
    If device is use in offline mode the images are stored only within the applications memory until device is connect and documents are submitted
12. What is Mix Panel?
    Mixpanel is a third party vendor that will allow internal users (product owners, stakeholders, development team) to track user behaviors. This will provide insights on how to improve the overall experience of the product.
13. Will the app work with Windows Surface Tablet?
    Currently the scanning technology we use does not have an SDK for Microsoft, so myTI will not work. HOWEVER, if an Android emulator is used on the surface tablet the app will work.

1. Are there any configurations that need to be made on the eTMF side? Anything that needs to be enabled?

Yes see below:

1. What are thoughts from FDA on “editing” (changing lightness/contrast) scans? I know FDA says they need to be captured in at least 300 DPI but what about editing them? We are not editing the actual document. Does the changing of lightness and/or contrast show up on an audit trail? Editing (contrast/ brightness) does not change the DPI. These adjustments do not appear on an audit trail.

1. Are there any countries myTI is not allowed to use in? I know JV’s clients in China use it so if it’s avail there, I assume it can be used anywhere.
   No myTI is available in all countries
2. Confirming it’s a certified copy – Can you change the text or criteria?
   In version 1.4 the certified copy text will be able to be updated per company code
3. Languages: The language setting matches to the language of your phone, not the eTMF, right? We only have the 11 local languages avail, right?
   Use System Language option enabled will look at the language the device is using and show the translation if available.
   Language available

1. German
2. French
3. Italian
4. Hebrew
5. Japanese
6. Korean
7. Portuguese
8. Russian
9. Turkish
10. Chinese
11. Spanish

1. TI10 Demo room. I want to set up users for myTI to link with the most recent demo rooms we are using for eTMF. Has that been done already / how can I help? I want to give better demos by showing how it comes up in the eTMF.
2. The Company code for the Sandbox Env will be "Sandbox". Set up for the company code should be completed by 9/4. To enable a room for myTI this can be done by SA or email the helpdesk (then add editor users to the myTI group and assign them to a site as a CRA)

For Offline Mode:

• Only available if Biometric Authentication is enabled. The app uses biometrics to authenticate the user (the device gives the app a yes or no if the biometrics passes validation). Images taken in offline mode are only stored in the apps encrypted memory until an internet connection is made. Once connected, user will need to enter in credentials or biometric log-in to upload documents taken during offline mode.
• During offline mode and RAM, the app is STILL 21 CFR Part 11 compliant.
• Can only code/submit when connected to WiFi/Cellular but able to capture the documents.
• Can clients opt out of their users having the ability to use myTI offline?

  -No

Company Code:

Used for ALL studies. Create a company standard (based on their preferences for users). When creating a company code, you’ll define if Light/Full submission, true cert or simple confirmation, biometrics/etc. is required initially (will apply to all studies that have myTI turned on).

For App Updates:

We control if/when users NEED to update the app. If a forced upgrade is required, we will communicate this to the client. This may happen if there’s an update for TI that affects myTI integration.

Cache Answers: For internal use only

Are documents stored on my device? No

Is data stored on my device? Temporarily

How long are documents/data stored for on my device? They are cached during upload to the server.

Can this be used offline (e.g., in a basement…)? Yes, assuming that this meets internal quality standards. The temporary cache may be disabled if needed.

How will this work if I have no wifi or data connection? If cache is enabled, documents will stay encrypted in the local cache as they attempt to upload to the Trial Interactive eTMF service

How do you ensure this data securely only goes into TI? These documents may not be accessed in any way while the phone is powered on, and as soon as it is powered off, they disappear, encrypted in transient memory only.

For the external statement:

The myTI application is a mobile extension of Trial Interactive, a cloud based e-clinical platform. Users login using Apple’s Touch ID and safely capture documents with their device camera. Immediately after you have captured a document using myTI, the document is temporarily cached within myTI until the transfer to Trial Interactive eTMF is complete. This is also true if you temporarily lose your connection immediately before or during document transfer. Nothing is ever stored permanently on your device. myTI is fully secure and 21 CFR Part 11 Compliant, and the myTI Cloud hosting environment fully complies with regulatory standards for storage of entrypted eTMF documents.

**Let’s plan to make the cache configurable by client, from zero (no cache) to 24 hours. We will default it to 12 hours. This means that docs will be cached encrypted on the device for up to 12 hours, ideally in RAM only (if possible), but are deleted as soon as they are successfully uploaded.

Trisha @ Agility:

For mobile apps for data privacy, data security tends to be important as there is potential data being stored on the device. Is data stored/cached locally on the device? If so how is that secured?

Yes, absolutely data security is critical and we take it very seriously. myTI was designed and built to not store anything on the device. That means no data, documents, or images are stored on the device; immediately after you have captured a document using myTI, the document is temporarily cached within myTI until the transfer to Trial Interactive eTMF is complete. The temporary cache may be disabled if needed. All operational app data is encrypted at all times. We ensure data securely only goes into TI as the documents may not be accessed in any way while the phone is powered on, and as soon as it is powered off, they disappear, encrypted in transient memory only.

This is also true if you temporarily lose your connection immediately before or during document transfer. Nothing is ever stored permanently on your device. myTI is fully secure and 21 CFR Part 11 Compliant, and the myTI Cloud hosting environment fully complies with regulatory standards for storage of encrypted eTMF documents