Tomoshibi - Trial Recruitment and eConsent Platform for a Japanese SMO

Dashboard, leads pipeline with board and table views, lead detail, consent status with a version matrix, and the participant consent record. Every one of the 29 leads and 29 participants opens its own page.

Self, legally acceptable representative, impartial witness, and guardian consent with child assent. Each participant's timeline shows the signatures its route needs, then the investigator's.

Lead cards turn amber after 1 working day without contact and red after 2, and the sidebar badge turns red when any lead is past the SLA.

5 studies at 6 partner sites, 9 consent document versions with IRB approval dates, 5 pre-screen questionnaires with eligibility rules, 7 campaigns, 29 leads and 12 staff users.

Recruitment Without a Funnel

Leads came from posters, a phone line, patient associations and agency spreadsheets. With no shared pipeline, nobody could tell which channel produced consented participants rather than calls, and sponsors asked for recruitment data the SMO could not produce.

Health Data Before the First Call

Under APPI, medical history is special care-required personal information. The person's prior consent is generally needed before any health answer is stored, and it cannot be shared on an opt-out basis, so identifiable lead data never reaches sponsors.

Paper Consent Monitors Kept Flagging

A CRC read a 20 to 40 page explanatory document aloud and the investigator signed later. Monitors regularly found missing dates, superseded versions signed after an approval date and copies never handed to the participant.

Re-Consent Found by Hand

When new safety information leads to a revised document, J-GCP generally requires renewed written consent. Each new IRB-approved version meant CRCs searching binders for who had signed what, while participants kept coming in for visits.