Sickle cell trials count crises, many of them treated at home or at hospitals that are not the study site. Capture records each vaso-occlusive event with its source, runs the pain diary on the participant's phone and handles consent for adults and for children. Build free, no credit card.
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Event details
Event type
VOETYPEOnset date
VOESTDTWhere treated
VOELOCOpioid given
OPIOIDHospital days
HOSPDAYSSource discharge summary requested
What a sickle cell trial needs from its EDC
The study data
The outcome that matters most to people with sickle cell disease is the crisis. Drug trials in this population have commonly used the annualised rate of vaso-occlusive events (also called crises) as an efficacy endpoint, alongside haemoglobin response and measures of haemolysis, with patient-reported pain and function as secondary measures. Gene-therapy programmes report related outcomes: for example, the manufacturers of exagamglogene autotemcel and lovotibeglogene autotemcel have described participants free of vaso-occlusive events for sustained periods after treatment, over follow-up that already runs to several years (company and conference summaries; check the primary publications). Event definitions differ between protocols, so write yours into the form rather than relying on memory.
That definition problem becomes a data problem. A crisis counts only if it meets the protocol rule, usually involving pain that needs medical contact, plus a defined set of complicated events such as acute chest syndrome, priapism and sequestration. In Capture a vaso-occlusive event is a repeating row with its own audit trail: type, onset and end dates, treatment setting, whether an opioid was given, admission and discharge dates, and a source-document field. A confirmation status (reported by participant, confirmed by medical record) lets the team separate what was said from what is documented. The adverse event template shows how to keep an efficacy event and a safety event distinct, so a hospitalised crisis is not entered twice.
The participant also keeps a record between visits. Capture can run a pain diary on the participant's phone through a secure link, with reminders and a completion window, so the pain score on the day of a crisis is captured at the time rather than recalled at the next visit. The pain diary template and the numeric pain rating scale show the layout; see digital patient diary for clinical studies for how diary compliance is monitored. The diary is a participant-entered record. It does not replace the clinical documentation that confirms an event.
The hematology trials page covers haemophilia bleed diaries, transfusion logs and blood cancers. Sickle cell has its own shape: crisis definitions, an adolescent and young adult population with high health-system mistrust, hydroxyurea as background standard of care, and transcranial Doppler screening for stroke risk in children in many protocols. If you run a study across several haematology conditions, build separate forms for each rather than stretching one.
| Assessment | Screen | Baseline | Mo 1 | Mo 3 | Mo 6 | Mo 12 |
|---|---|---|---|---|---|---|
| Haemoglobin, HbF, bilirubin, reticulocytes | ||||||
| Vaso-occlusive event review | ||||||
| Daily pain diary (phone) | D | D | D | D | D | |
| Hydroxyurea dose and adherence | ||||||
| Transfusion history | ||||||
| Quality of life questionnaire |
x = visit form, D = participant diary entries
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Genotype, number of prior events, hydroxyurea status, age band | Eligibility screening template |
| Vaso-occlusive events | Type, onset, setting, treatment, admission, source | Repeating event form with confirmation status |
| Pain between visits | Daily pain score, analgesic use | Pain diary on the participant's phone |
| Haemoglobin and haemolysis | Hb, HbF, bilirubin, LDH, reticulocytes | Laboratory template with ranges by sex and age |
| Transfusions | Dates, units, indication | Repeating transfusion rows |
| Background medicines | Hydroxyurea dose, L-glutamine, crizanlizumab or other | Concomitant medications template |
| Consent and assent | Adult consent, parental permission, child assent | Paediatric assent consent template |
| Adverse events | Infusion reactions, infections, cytopenias | Adverse event form |
Event definitions come from your protocol. Capture records and exports the data; it does not classify a crisis for you.
Draft the event form, the diary and the assent flow, test them with sample participants and export the blank eCRF PDF for your committee. Free sandbox, no credit card.
Consent and long-term follow-up
Many sickle cell trials enrol children, so a parent or guardian gives permission and the child gives assent in age-appropriate language. Capture's eConsent supports the participant signature with an email one-time code, an optional witness and a Legally Authorized Representative signature, and a document is fully executed only after the investigator countersigns. Start from the paediatric assent template and have your ethics committee set the age bands and wording. Adolescents who reach adulthood during a long study may need to re-consent as adults; plan the process in the protocol, since this page does not claim automated re-consent.
Gene and cell therapies add long-term follow-up. Regulators have asked that participants treated with these products be followed for many years after dosing for delayed adverse events (FDA's long-term follow-up guidance for gene therapy products has discussed periods of up to 15 years for some products; confirm the duration that applies to your product). In Capture the follow-up is an epoch with a sparse visit plan, annual forms and a small set of safety fields, so the early-phase data and the later follow-up sit in one record with one audit trail. See long-term extension study software.
Access to care is part of the design. Participants may live far from an expert centre and be treated for crises elsewhere. Phone-based diaries, QR-code enrolment and a site coordinator portal reduce the burden. For the participant side, EDC with eConsent explains how consent and data entry share one record.
Build sequence
Copy the protocol's crisis and complicated-event definitions into the form help text, so every site applies them the same way.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
Set the pain diary on the participant's phone with reminders and a completion window; no app is required.
Haemoglobin ranges by sex and age, transfusion consistency checks, and allowed windows around each visit.
Sign a parental permission and a child assent in the sandbox, then countersign as the investigator.
Approved forms lock for live use. Real participants start the paid live phase.
Before first participant
Crisis and complicated-event rules copied from the protocol, with a source-document list.
How a participant tells the site about a crisis treated elsewhere, and who requests the records.
Whether red cell exchange or simple transfusion counts, and the look-back period.
Age-banded wording signed off by the ethics committee.
Reminder schedule and a by-site view of missed entries.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. Each event is a repeating row with type, dates, treatment setting, admission details and a source field, and each row has its own audit trail. The event definition itself comes from your protocol.
Yes. A pain diary runs on the participant's phone through a secure link with reminders and a completion window, and no app is needed. It records the participant's report; the site confirms events with clinical records.
The hematology page covers haemophilia, transfusion logs and blood cancers. This page is specific to sickle cell: crisis definitions, paediatric consent, hydroxyurea background therapy and gene-therapy follow-up.
Yes, through the eConsent flow with parental permission, child assent and optional witness. Your ethics committee decides age bands and wording.
Yes. Build follow-up as an epoch of the same study with annual visits and safety fields. The duration required depends on the product and regulator; confirm it for your programme.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with site-level numbering, a site coordinator portal and by-site exports.
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants. Pricing is not published on the site, so ask for terms for your study.
Keep exploring
EDC for hematology trials
Haemophilia, transfusions and blood cancers.
Digital patient diary
Phone diaries with compliance tracking.
Paediatric assent template
Assent plus parent permission.
Pain diary template
Daily pain score layout.
EDC for paediatric trials
Age-banded design.
Long-term extension software
Years of follow-up as an epoch.
Free sandbox with every feature. No credit card, and you pay only when you go live.