Roles and responsibilities, expectation setting and study overview
Minimizing placebo effect
Accuracy in reporting on PRO/ePRO, ClinRO/eClinRO, ObsRO/eObsRO and PerfO/ePerfO duration, severity and frequency including definitions and terminology
Importance of compliance with study tasks and procedures and medication/product adherence
“How-to” video-based tutorials for demonstrable procedures and tasks, such as using wearables, biosensors, DIY kits, collecting biological specimens and medication/product use
Study workflow and use of technology (i.e., devices, medical devices, software, mobile apps, systems integration)
Reporting on potential AE/SAE, concomitant and prohibited medications or products
Comprehension assessments, refresher training, remediation, reporting and trend analysis
Training is available 24/7
Section 508 compliant digital training to enable participants, caregivers, site staff, and clinicians with disabilities to receive the same access to the training materials used by their peers*
*Section 508 is an amendment to the Rehabilitation Act of 1973 which prohibits discrimination on the basis of disability. SPRIM’s digital training has closed captioning for the hearing impaired, as well as alternative text to describe images relevant to training and sequencing for those who are visually impaired and use screen readers and/or their keyboard to complete training.
Clinical experts rate image, audio and video files in a blinded manner for clinical trials, improving the quality of patient and caregiver reported outcomes
Technology enables PHI scrubbing and resolution/sizing for image capture
Reconciliation of primary and secondary rater scoring and consensus