FDA PRO Guidance and ePRO patient reported outcomes solutions with patient eDiaries

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"Overall, I was always comfortable using (the LogPad). And I think it's good to know that as soon as you've completed the input of data, it went straight-away to wherever, and it couldn't possibly get lost. And I think that, in particular, is about 100% better than paper."

Elderly female subject
in a Cambridge, UK, rheumatoid arthritis trial

Read more on what people are saying about PHT.

Collecting Electronic Patient-Reported Outcomes (ePROs):

Comparing the 5 Proven Ways to Acquire Attributed Patient-Reported Data

ePRO Selection Tool


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with Code PHT4PRO


Download the PHT ePRO Tool .exe
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Open this URL
on your Android,
iPhone or Blackberry:

www.phtcorp.com/epro_mobile/



The Five Reliable Collection Methods and Devices Used to Collect ePRO

While the flurry of new patient-owned mobile devices may seem adaptive to ePRO collection and perhaps practical, using the patient's own technologies to capture ePRO can be risky for many reasons including

  • Psychometric validity of multiple types of devices, and
  • Data security and compliance with regulatory guidelines.
...using the patient's own technologies to capture ePRO can be risky for many reasons...


Each ePRO collection method and device must be thoroughly vetted in order to comply with various FDA, EMA and country regulations and requirements for clean, attributable data. As a result, there are currently five proven and tested ePRO technologies used by sponsors today (listed alphabetically):

  1. Hand Held Device: Electronic data capture on a mobile device with a central system that allows for web review;
  2. IVR (Interactive Voice Response): Keypad or voice data capture with a central system that allows for web review by site and sponsor;
  3. Internet Web data capture with a central system that allows for web review by site and sponsor;
  4. Pen: Digital pen that captures data and uploads to a central system that allows for web review; and
  5. Tablet: Electronic data capture on a tablet mobile device with a central system that allows for web review.

Download the review of each collection option here.


More information on
Collecting PRO Data


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Which Collection Method for PRO data will best support your trial?


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Why Paper Should be Banned in Clinical Trials


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Compare the 5 Proven Ways to Acquire Attributable Patient-Reported Data


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