Functionality & Operations FAQs

Note: Click on each question to expand and view the response.

Why are the draft documents no longer available after the upgrade?

The draft documents are no longer available because the application was reinstalled. A fresh installation of the myTI app clears all locally stored data, including saved draft documents. This is expected system behavior and explains why the drafts cannot be recovered.

After a picture has been taken, can you redact the document before uploading it?

No, but the document can be redacted once in TI using the built-in redaction tools.

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.

How many pages/documents can it upload at a time?

There is no limit to how many can pages be uploaded at once.

Can it take images in color and black/white?

Yes.

Can you submit images without putting in the required fields?

This is something currently being worked upon. Currently, it is necessary to fill out all required metadata fields before submitting a document.

Do mobile uploads convert the documents to PDF?

Yes.

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; it needs to go through a QC process.

What software is used for document capture and uploaded to eTMF?

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.

How does the naming convention work for documents being uploaded into the eTMF?

The submitted name will be associated with the document type selected.

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

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.

Can I see the other CRAs working on this study/at this site?

Yes, CRAs assigned to a site can view all documents submitted by other users at that site.

What is the DPI for myTI?

Documents are captured at a minimum of 300 DPI as per FDA requirements.

Can myTI be used when offline? How does offline mode ensure data security?

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.

Is OCR used? If yes, does OCR straighten the documents?

Not at this time; this is being considered for future versions of myTI.