Process Sequence

1. PATIENT REGISTRATION

Patients who are interested in participating in your trial are registered with their personal data. premierConsent® allows to combine patient data with a patient picture in order to facilitate patient identification for all the involved study personnel.

Legally acceptable representatives or impartial witnesses can be registered accordingly, if necessary.

Various control mechanisms and database matching in input masks for patient data reduce the risks of mistakes and prevent multiple inclusions of the same patients. Data import from electronic health records might be implemented to speed up the registration process.

2. premierConsent introduction

Patients that are interested in consenting with premierConsent® are educated by the app about the consenting process that awaits them.

Subsequently, they are given the opportunity to proceed the consenting process with premierConsent® and make use of the system’s superior ability to inform them about all relevant aspects of a clinical trial.

The approval of patients to proceed the consenting process with premierConsent® is audio- visually captured. In order to ensure a consistent and high quality of these recordings, premierConsent® applies advanced quality management mechanisms.

3. MULTIMEDIA EDUCATION

premierConsent® educates patients about clinical trials with tailor-made, easy-to- understand, animated content modules. These modules take ethical peculiarities into account and are adjusted to the didactical needs of the respective patient population.

Depending on our customer’s requirements, we offer different content packages ranging from rather abstract to photo-realistic animations. After each content module, patients give their feedback on how well they understood the presented information.

This feedback is then summarized for the investigator, who can in turn specifically address possible deficits of patient understanding.

4. PERSONAL PATIENT EDUCATION

Multimedia education is followed by a personal education session. Investigators educate patients about the content of the study and have the opportunity to specifically focus on topics where patients have previously been identified to need further information.

Hence, premierConsent® allows improved patient education at reduced time efforts of investigators. A personalized informed consent form is printed out or sent via e-mail for the patients for decision making.

The personal patient education is audio-visually captured. In order to ensure a consistent and high quality of these recordings, premierConsent® applies advanced quality management mechanisms.

5. PATIENT CONSENT

The use of premierConsent® ensures that patients have sufficient time to decide about their participation in the study. The final step of the informed consent process using premierConsent® is the actual consent.

Verbalized consent and written informed consent on a personalized, paper-based informed consent form are captured audio-visually/auditively in parallel.

premierConsent® guarantees that signatures of the patients and the investigators are given in the correct sequence. The whole informed consent process is easily comprehensible for patients and investigators but also other stakeholders.