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CANKADO ePRO Tool For Each Trial
The CANKADO Framework opens up entirely new opportunities to document electronic patient-reported outcomes (ePRO). The system allows an easy and fast adaptation to the protocol requirements. Multi-lingual-support is as common as support of all types of Internet-enabled devices. A REST-API based secured connection to any eCRF system allows direct control of CANKADO. And all compliant with ICH GCP E6 (R2).
Questionnaires
Supporting validated and self-developed questionnaires were the starting point of CANKADO. Today a wide range of opportunities do exist. Hundreds of standard questionnaires are already in the system. New surveys can be created quickly and easily.
The number of questionnaires used within a trial is not limited. Also pulling together of questionnaires from a backbone questionnaire and a situation-specific extension is supported. Repetitions can be set independently for a questionnaire or a group of questionnaires.
A questionnaire does always contain the questions with answers and their answer value. It also includes a translation table for the desired languages, as well as the direct calculation of scales and scores.
In clinical trials, it can be defined if the investigator or study nurse is allowed to see the selected answers and/or the scores. Beside the investigator or study nurses, a trial monitor can track in real-time if questionnaires are completed or if and where data entries are pending. The real-time monitoring guarantees a fast and comprehensive overview of all activities.
Languages and Countries
For cross-border studies, the multilingual nature of surveys is indispensable. Therefore, the questionnaires in CANKADO are also multilingual and each kind of language or graphemes can be supported. Today, in addition to the leading languages in Latin characters, there are also Russian, Arabic, Turkish, Greek, and Chinese. Questionnaires can be used in all languages simultaneously. Translations are not carried out automatically, but only the validated versions manually entered and released by a four-eyes principle. It is not needed that the physician and the patient use the same language. This is helpful for countries like Switzerland or Canada with more than one official language or if you plan a trial for patients with a migration background.
Ways of availability
Different trials need different ways of questionnaire access. CANKADO provides a wide range of access control. Find below the list of access types.
Always on means that the patient has the questionnaire in their online profile always available. Also, they can use a questionnaire specific QR code or a login-free five-digit code for www.mamebe.com
Sleep and awake is an access feature for all trials, which requires an assessment under specific conditions, like before a visit. The questionnaire is predefined but will need an awakening from the study nurse. After awaking the questionnaire can be answered for 90 minutes and will fall into sleep automatically afterward.
Uniform repetition rhythm is useful for all trials with a predefined and constant rhythm, like every six weeks. The rhythm can be defined within each arm independently.
Irregular repetition rhythm is normally used in trials, which have a decreasing probability of events. Each kind of fix defined time distances from day 0 can be defined.
Dynamic access is one of the unique key features of CANKADO. Within here, the questionnaire can be started based on a trigger event. This trigger event is typically a significant change in global health status or pain.
QR Code
Fast and easy access matters in routine. Therefore, CANKADO provides for each patient-specific questionnaire a unique QR code. This code allows to open and answer the questionnaire without logging in. The patient can use his smartphone or tablet, scan the code, and directly answer the survey. Also, CANKADO now operates more than 400 of its terminals, which provide direct access to the patient via the QR code.
Self-Tracking
Three groups of self-tracking devices are supported in CANKADO. Most commonly are devices which provides an API integration. CANKADO has a general API to access self-tracking data from most devices. Typical measurements are for tracking steps, weight, heartbeat, blood pressure, or sleep.
Some devices only provide SDK’s for direct data access via the APP. The CANKADO patient APP is made for such kind of integration. Currently available is a body temperature patch for continuous temperature measurement.
In some cases, data has to be extracted from export documents. Currently, CANKADO supports data extraction from ECG devices like the AliveCor Kardia or the Apple Watch 4. These single lead ECG record can be used for telecardiology findings.
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