EDC for hematology trials, from bleed diaries to response criteria
Hematology trials run on repeated blood counts, event logs such as bleeds, crises and transfusions, and disease-specific response criteria. Capture handles repeating logs with their own audit trail, lab tables with reference ranges and participant diaries in one study.
- Bleed and transfusion logs
- Lab tables with reference ranges
- Participant bleed diaries
Free sandbox · No credit card · 21 CFR Part 11 aligned
Bleed diary · New entry
Subject 021-0004 · Haemophilia A
Date and time bleed started
Location
Cause
Treated with factor
What matters in hematology trials
- Haemophilia trials use the annualised bleeding rate (treated bleeds per year) from participant bleed diaries, plus factor activity levels and inhibitor testing.
- Anaemia trials, including thalassaemia and myelodysplastic syndromes, often use transfusion independence or reduction in transfusion burden, which needs a complete transfusion log with pre-transfusion haemoglobin.
- Sickle cell disease trials count vaso-occlusive crises, with a clear event definition and healthcare utilisation data.
- Blood cancer trials use disease-specific response criteria, for example for lymphoma, myeloma and leukaemia, built from labs, marrow and imaging.
- Most hematology trials are lab-heavy: frequent blood counts with sex- and age-specific reference ranges.
Study design
Event logs are the endpoint
In many non-malignant hematology trials, the primary endpoint is a count of events over time: bleeds, crises, transfusions. That makes the event logs the most important data in the study. Each event needs its date, type, cause or trigger, treatment and outcome, recorded consistently so events can be counted and classified in analysis.
Some events are recorded by participants at home (bleeds in haemophilia), others by sites from medical records (transfusions, hospital admissions for crises). Both types work best as repeating rows, one per event, where each row carries its own audit trail. Define in the protocol what counts as a separate event, for example a new bleed at the same site within 72 hours counted as the same bleed.
Gene and cell therapies
Haemophilia, sickle cell disease and thalassaemia are major areas for gene and cell therapies, which bring long-term follow-up and specific safety monitoring. See EDC for cell and gene therapy trials.
Units, 24 weeks before
14
Units, weeks 13 to 24
4
Reduction
71%
Repeating logs
One row per event, each with its own audit trail
Table sections hold repeating rows for transfusions, bleeds recorded at sites, or crisis events. Each row carries its own field-level audit trail, and range checks on values such as pre-transfusion haemoglobin raise queries at entry. Participant bleed diaries run on their own phones from a secure link.
- Repeating rows with per-row audit trail.
- Range checks with auto-queries.
- Participant diaries without an app.
Laboratory data
Blood counts with the right reference ranges
AI can draft lab tables from a lab manual or file, with analytes as rows, units, results and reference ranges split by sex and age where the source has them. Nothing is saved without review. Range checks flag values outside expected limits so they are confirmed quickly.
- AI-drafted lab tables for review.
- Reference ranges by sex and age.
- Range checks at entry.
Haemoglobin HGB · g/dL
3 strata- General13.0 to 17.0
- Female 18-6412.0 to 15.5
- Female 65+11.5 to 15.0
Build a transfusion log and lab table
Set up repeating rows and reference ranges in the free sandbox.
Endpoints
Hematology endpoints and their data
| Condition | Typical endpoint | Data needed |
|---|---|---|
| Haemophilia | Annualised bleeding rate | Bleed diary with date, location, cause, treatment; exposure days |
| Thalassaemia, MDS anaemia | Transfusion independence or burden reduction | Transfusion log with units, dates and pre-transfusion haemoglobin |
| Sickle cell disease | Annualised rate of vaso-occlusive crises | Event forms with definition criteria and care setting |
| Immune thrombocytopenia | Platelet response | Platelet counts over time, rescue therapy |
| Lymphoma, myeloma, leukaemia | Response rate, progression-free survival, MRD | Response assessments per disease criteria, labs, marrow, imaging |
Patient experience
Fatigue, pain and quality of life
Anaemia causes fatigue, sickle cell disease causes pain, and blood cancers and their treatments affect every part of life. Patient-reported outcomes such as FACIT-Fatigue are common secondary endpoints, and they are most complete when collected at home between visits rather than only in clinic.
In malignant haematology, performance status and quality of life are recorded alongside response. See the Karnofsky template for transplant settings and EDC for oncology trials for tumour response workflows.
Study build
Hematology study build checklist
Event definitions
Bleeds, crises or transfusions defined, including when events merge.
Event logs
Repeating rows or participant diaries with the defining fields.
Historical baseline
Pre-study event or transfusion history for comparison.
Lab table
Blood counts with sex- and age-specific reference ranges.
Response criteria
Disease-specific criteria written into forms.
PROs
Fatigue or pain measures at home between visits.
What is the annualised bleeding rate?
The number of treated bleeds per year, calculated from participant bleed diaries. It is the main efficacy endpoint in many haemophilia trials.
How is transfusion independence measured?
From a complete transfusion log over a defined period, often with pre-transfusion haemoglobin thresholds.
Can participants record bleeds at home?
Yes. A bleed diary opens on the participant's phone from a secure link, with no app.
Do repeating rows have their own audit trail?
Yes. Each row in a repeating log carries its own field-level audit trail.
Can lab reference ranges differ by sex and age?
Yes. Lab tables can hold reference ranges split by sex and age.
Can I try it free?
Yes, in the free sandbox with every feature.
Every bleed, crisis and transfusion counted
Repeating logs, diaries and lab tables. Free sandbox.