MICT · EVIDENCE OPERATIONS

Clinical Forms

Normalized PMCF data capture.

Controlled PMCF cohortSupplementary observations are tracked separately.

SUBJECT EXPLORER

Find patient by National ID

Search existing longitudinal record.

RECENT SUBJECTS

Recently active PMCF records

VISIT / eCRF

New PMCF visit

Raw measurements are the source of truth.

Draft

Visit no.

Visit date

Visit time

Clinical site

Device serial number

Device age

—

Usage count

—

Measurement conditions

Position

Arm

Arm circumference

Cuff size

Rest before measurement

Recent physical activityRecent caffeineRecent smoking

Patient condition notes

Device condition at visit

Battery status

Cuff condition

Visible device damageDevice malfunction reported

Raw repeated measurements

#	SBP	DBP	Pulse	MAP	Duration	Success	Error code	IHB	Movement	Cuff error

Safety and device events

Adverse event occurred

Complaint reported Measurement discontinued due to device

Visit notes

DATA EXPORT

Analysis-ready datasets

Normalized datasets.

Subjects CSV Visits CSV Measurements CSV Adverse Events CSV Devices CSV Excel workbook

CRF / ePRO

New clinical observation

DATA MODEL

Repeated observations

Pulse oximeter form.

PARTICIPANT-LEVEL DATA

Visible CRF/ePRO records

Subject	Age/Sex	Visit	Date	SpO₂	Pulse	PI	Valid	Repeat	Source	Submitted by