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Study Information

CALLA Phase III Clinical Trial
CALLA-2024-001
Pharma Research Inc.
Advanced Solid Tumors

Visit Schedule

8 visits
1ScreeningDay -28 to -1
2BaselineDay 1
3Week 2Day 14 ± 3
4Week 4Day 28 ± 3
5Week 8Day 56 ± 5
6Week 12Day 84 ± 5
7End of TreatmentDay 112 ± 7
8Follow-upDay 140 ± 14

Forms (eCRFs)

6 forms
Demographics 8 fields
Date of Birthdate
Sexselect
Raceselect
Ethnicityselect
Height (cm)number
Weight (kg)number
Initialstext
Countryselect
Vital Signs 7 fields
Measurement Datedate
Systolic BP (mmHg)number
Diastolic BP (mmHg)number
Heart Rate (bpm)number
Temperature (°C)number
Respiratory Ratenumber
Positionselect
Adverse Events 10 fields
AE Termtext
Start Datedate
End Datedate
Severityselect
Seriousselect
Relationshipselect
Action Takenselect
Outcomeselect
Ongoingselect
Commentstextarea
Concomitant Medications 6 fields
Medication Nametext
Indicationtext
Dosetext
Frequencyselect
Start Datedate
End Datedate
Medical History 5 fields
Conditiontext
Start Datedate
End Datedate
Ongoingselect
Commentstextarea
Lab Results 6 fields
Collection Datedate
Test Nametext
Resultnumber
Unittext
Normal Rangetext
Flagselect
Creating study record...
Creating 8 visits...
Creating 6 forms...
Creating 42 form fields...
Mapping forms to visits...
Creating test subject (TEST-001)...

Study Published Successfully!

Your study has been created in the database

1 Study
8 Visits
6 Forms
42 Fields

Created Database Items

Study

CALLA Phase III Clinical Trial ID: 1

Visits (8)

Screening
Baseline
Week 2
Week 4
Week 8
Week 12
End of Treatment
Follow-up

Forms (6)

Demographics8 fields
Vital Signs7 fields
Adverse Events10 fields
Concomitant Medications6 fields
Medical History5 fields
Lab Results6 fields

Test Subject

TEST-001 Ready for data entry

Enrolled Subjects

1 subject
Subject ID Status Enrolled Date Last Visit Forms Completed
TEST-001 Active Jan 7, 2026 Screening 0 / 48

Visit Schedule

8 visits
Order Visit Name Window Forms Required
1 Screening Day -28 to -1 6 forms
2 Baseline Day 1 6 forms
3 Week 2 Day 14 ± 3 4 forms
4 Week 4 Day 28 ± 3 4 forms
5 Week 8 Day 56 ± 5 4 forms
6 Week 12 Day 84 ± 5 5 forms
7 End of Treatment Day 112 ± 7 5 forms
8 Follow-up Day 140 ± 14 3 forms

Study Forms (eCRFs)

6 forms
Demographics 8 fields

Mapped to Visits

Screening Baseline

Fields

Date of Birthdate
Sexselect
Raceselect
Ethnicityselect
Height (cm)number
Weight (kg)number
Initialstext
Countryselect
Vital Signs 7 fields

Mapped to Visits

Screening Baseline Week 2 Week 4 Week 8 Week 12 End of Treatment Follow-up

Fields

Measurement Datedate
Systolic BP (mmHg)number
Diastolic BP (mmHg)number
Heart Rate (bpm)number
Temperature (°C)number
Respiratory Ratenumber
Positionselect
Adverse Events 10 fields

Mapped to Visits

Baseline Week 2 Week 4 Week 8 Week 12 End of Treatment Follow-up

Fields

AE Termtext
Start Datedate
End Datedate
Severityselect
Seriousselect
Relationshipselect
Action Takenselect
Outcomeselect
Ongoingselect
Commentstextarea
Concomitant Medications 6 fields

Mapped to Visits

Screening Baseline Week 12 End of Treatment

Fields

Medication Nametext
Indicationtext
Dosetext
Frequencyselect
Start Datedate
End Datedate
Medical History 5 fields

Mapped to Visits

Screening Baseline

Fields

Conditiontext
Start Datedate
End Datedate
Ongoingselect
Commentstextarea
Lab Results 6 fields

Mapped to Visits

Screening Baseline Week 4 Week 8 Week 12 End of Treatment

Fields

Collection Datedate
Test Nametext
Resultnumber
Unittext
Normal Rangetext
Flagselect

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