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Subject Clinical Data Capture

This guide covers how to record clinical data for an enrolled subject. Each subject record has eight data sections accessible from the Subject Navigation panel on the left side of the screen.

Target Audience​

RoleAccess
Study CoordinatorFull data entry access for assigned subjects
Principal InvestigatorRead-only review access

Subject Record Overview​

After clicking a subject's name from the Subjects tab, you land on their record. The screen is divided into two areas:

Subject record overview — navigation panel on left, header card and data section on right

Left panel — Subject Navigation: Links to each of the eight clinical data sections. Click any section to jump to it.

Right panel — Subject Header Card: Displays the subject's key information at a glance:

FieldDescription
Name & AvatarSubject's full name with initials avatar
Email / PhoneContact details from the patient record
Status badgeActive, Withdrawn, Completed, etc.
Subject IDSystem-generated ID (e.g., SUB-0003)
Demographics tileAge and Gender
Current StudyStudy name, type, phase, start and end dates
Height / WeightUpdated after a Vitals record is saved

The main content area below the header card shows the currently selected data section.

The Consent section is the starting point for every subject record. Consent records are permanent — they cannot be modified or deleted once saved.

Consent records are immutable

Once a consent record is created it cannot be edited or deleted. Verify all details before saving.

  1. Click Consent in the Subject Navigation panel
  2. Click + Add Consent (top right) or Add First Consent
  3. The Add Consent Record form opens:

Add Consent Record form — consent status and agreement fields

FieldRequiredNotes
StudyPre-filledThe study the subject is enrolled in
Consent Status✅Willing to participate or Does not wish to participate
Consent StatementRead-onlyStandard ICF statement displayed for reference
I agree✅Checkbox confirming the subject has agreed
  1. Select the appropriate consent status, check I agree, then click Save

After saving, the consent record is displayed with approval details:

Consent approval screen — saved consent record with status and timestamp

Demographics​

The Demographics section records the subject's baseline personal and physical characteristics.

Demographics Overview​

Demographics overview — list of recorded demographic entries

Recording Demographics​

  1. Click Demographics in the Subject Navigation panel
  2. Click + Add Demographics
  3. Fill in the demographics form:

Demographics entry form — personal details and physical measurements

The form collects personal details including date of birth, gender, nationality, and address fields. Click Save when complete.

Vitals​

The Vitals section records physical measurements at each study visit. Multiple vitals records can be created — one per study event/visit.

Vitals Overview​

Vitals overview — list of recorded vital sign entries by study event

Recording Vital Signs​

  1. Click Vitals in the Subject Navigation panel
  2. Click + Add Vitals
  3. Fill in the Edit Vital Signs form:

Vitals entry form — height, weight, BMI, temperature, and pulse fields

FieldUnit
Study EventSelect the visit (e.g., Baseline Visit, Follow-up)
StudyPre-filled
HeightMetres
WeightKilograms
BMIAuto-calculated or manual
Temperature°C
Pulsebpm
  1. Click Save — the record appears in the Vitals list:

Vitals saved view — recorded vital signs displayed in the section

tip

Height and Weight saved here will also update the subject header card at the top of the record.

Family Medical History​

Records the subject's family history of medical conditions relevant to the trial.

Family Medical History Overview​

Family Medical History overview — list of recorded family history entries

Recording Family Medical History​

  1. Click Family Medical History in the Subject Navigation panel
  2. Click + Add Family Medical History
  3. Fill in the form:

Family Medical History entry form — condition, relationship, and notes fields

Record the family member's relationship, diagnosis, and any relevant notes. Click Save.

Concomitant Medications​

Records all medications the subject is taking concurrently with the trial treatment.

Concomitant Medications Overview​

Concomitant Medications overview — list of recorded concurrent medications

Recording a Medication​

  1. Click Concomitant Medication in the Subject Navigation panel
  2. Click + Add Medication
  3. Fill in the medication entry form:

Medication entry form — drug name, dose, frequency, and indication fields

  1. Click Save — the medication appears in the list:

Medication saved view — recorded concomitant medication entry

note

Subjects can also self-report concomitant medications via the Sublink mobile app, which will appear here for coordinator review.

Laboratory Results​

Records laboratory test results for the subject at each study visit.

Laboratory Results Overview​

Laboratory Results overview — list of recorded lab test entries

Recording a Lab Test​

  1. Click Laboratory in the Subject Navigation panel
  2. Click + Add Lab Test
  3. Fill in the Add Lab Test form:

Lab Test entry form — lab test type, name, and comment fields

FieldRequiredNotes
Lab Test✅Select from the master data list (e.g., Laboratory)
Lab Test Name / Description✅Specific test name
Comment—Observations or notes from the lab
  1. Click Save — the result appears in the list:

Lab test saved view — recorded laboratory result entry

Physical Examination​

Records findings from physical examination at each visit.

Physical Examination Overview​

Physical Examination overview — list of recorded examination entries

Recording a Physical Examination​

  1. Click Physical Examination in the Subject Navigation panel
  2. Click + Add Physical Examination
  3. Fill in the examination form with system-by-system findings:

Physical Examination entry form — body system findings and examination notes

Click Save when all findings are recorded.

Adverse Events​

Records any adverse events experienced by the subject during the trial. All adverse events are tracked for safety monitoring.

Adverse Events Overview​

Adverse Events overview — list of recorded adverse event entries with severity

Recording an Adverse Event​

  1. Click Adverse Events in the Subject Navigation panel
  2. Click + Add Adverse Event
  3. Fill in the Add Adverse Event form:

Adverse Event entry form — study, subject, event description, start and end dates

FieldRequiredNotes
StudyPre-filledAuto-populated from the subject's study
SubjectPre-filledAuto-populated from the subject record
Study Event✅Visit during which the event occurred (e.g., Baseline Visit)
Event Description✅Detailed description of the adverse event
Start Date✅Date the event began
End Date—Date the event resolved (leave blank if ongoing)
  1. Click Save — the event appears in the list:

Adverse Event saved view — recorded adverse event with dates and description

Safety reporting

Serious adverse events (SAEs) must be reported promptly per your site's regulatory obligations. The CTMS records the event — follow your site's SAE escalation process separately.

Quick Reference — All Data Sections​

SectionLeft Nav ItemAdd Button LabelKey Fields
ConsentConsent+ Add ConsentConsent Status, I agree
DemographicsDemographics+ Add DemographicsDOB, Gender, Nationality
VitalsVitals+ Add VitalsHeight, Weight, BMI, Temp, Pulse
Family Medical HistoryFamily Medical History+ Add Family Medical HistoryCondition, Relationship
Concomitant MedicationsConcomitant Medication+ Add MedicationDrug Name, Dose, Frequency
Laboratory ResultsLaboratory+ Add Lab TestLab Test, Name, Comment
Physical ExaminationPhysical Examination+ Add Physical ExaminationSystem findings, Notes
Adverse EventsAdverse Events+ Add Adverse EventEvent Description, Start Date, Study Event