Injury trials start in emergency care, depend on motor and functional scores measured by trained examiners, and follow people for months while consent often comes from a representative. Capture holds the acute, rehabilitation and follow-up data in one study. Build and test it free, no credit card.
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| Assessment | Baseline (<72h) | Day 14 | Day 30 | Day 90 | Day 180 | Month 12 |
|---|---|---|---|---|---|---|
| Neurological exam: motor and sensory scores | ||||||
| Functional independence measure | ||||||
| Global outcome (interview) | ||||||
| Hospital and rehab stay record | ||||||
| Caregiver or proxy questionnaire | P | P | P | P | ||
| Adverse events |
x = site form, P = proxy or caregiver completed
What an SCI or TBI trial needs from its EDC
The study data
Spinal cord injury (SCI) trials use a neurological examination as the backbone. The ASIA motor score sums the strength of key muscles on both sides, each graded 0 to 5, to a total of 0 to 100, and registered trials of neuroprotective drugs have used change in total motor score from baseline to a later day, such as 90 or 180, as the primary outcome. Impairment grade, neurological level and sensory scores come from the same examination. Functional recovery is measured with scales such as the Spinal Cord Independence Measure, version III, a 0 to 100 clinician-rated scale covering self-care, respiration and sphincter management, and mobility. Participants with traumatic brain injury (TBI) are usually assessed with the Glasgow Coma Scale at admission and a global outcome scale such as the Glasgow Outcome Scale Extended at three, six or twelve months, alongside cognitive, mood and symptom measures.
The data problems follow from the setting. Examination scores are only comparable when the examiner is trained and the participant is stable, so recording examiner, date and time since injury on every form is essential. Early baseline values are often entered under pressure; edit checks on impossible combinations, such as a motor score above 100, catch typing errors. In Capture each score is a site eCRF form with typed fields, derived totals shown read-only and every entry attributed to a named user, with the old value, new value and reason for any change in the audit trail. Retrospective entry from hospital records is common, so the audit trail matters for showing when data was added. The clinical trial software for rehabilitation research page covers the community and therapy side.
Follow-up is the second problem. Outcome interviews at six or twelve months depend on reaching participants who have moved from hospital to rehabilitation to home. Visit windows and a record of attempted contact make loss to follow-up measurable. When a participant has cognitive impairment, a caregiver or proxy may answer; record who answered on the form, because proxy and self-report are not always comparable. See the glossary entry on outcome types for the distinction.
Many injury programmes sit between neurology and rehabilitation. Cognitive screening can use forms such as the MoCA template, mood and anxiety can use the HADS template, and pain after injury is common enough to need a numeric pain rating scale. Stimulation and device studies, including spinal or cortical neuromodulation, add session records; the pattern is in EDC for tDCS and TMS neuromodulation studies. The broader field is EDC for CNS and neurology clinical trials.
Motor score
Examiner
EXAMINERUpper extremity motor score
UEMSLower extremity motor score
LEMSTotal motor score
TMSDerived, read-only
55 CalculatedDays since injury
DSIInside Day 90 window (85 to 100)
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and injury details | Date and time of injury, mechanism, level, severity | Eligibility screening template; date fields with edit checks |
| Neurological examination | Motor and sensory scores, impairment grade, examiner | Site eCRF form with calculated totals |
| Functional independence | Domain scores and total at later visits | Site eCRF form per visit |
| Global outcome | Category from a structured interview | Site eCRF form with respondent field (participant or proxy) |
| Cognition and mood | Screening totals | MoCA, HADS |
| Pain and quality of life | Numeric ratings and generic health measure | Numeric pain rating, EQ-5D |
| Representative consent | Representative signature, later participant consent | LAR consent; long-term follow-up consent template |
| Adverse events | Medical complications, seriousness, relationship | Adverse event form |
Scale wording is yours to supply. Licensed instruments stay with your study documents; Capture does not supply or verify instrument licences, and licence controls exist only on participant questionnaires.
Upload the protocol, let the AI draft visits and forms for you to review, and test with sample participants. Free sandbox, no credit card.
Consent and safety
In acute injury trials, participants often cannot consent when enrolment must happen. Where the protocol and ethics approval allow it, a legally authorised representative signs first and the participant is asked to confirm later when able. Capture eConsent supports Legally Authorized Representative signature, an optional witness and investigator countersignature, with each signature linked by hash to the exact document content at signing time. Who counts as a valid representative, and how deferred consent works, depends on the jurisdiction, so write the rules into the protocol and use the system to record them. The flow is described in legally authorized representative consent software, and the long-term layout in the long-term follow-up consent template.
Safety data in injury trials overlaps heavily with the injury itself, so attribution is hard. Pressure injuries, infections, respiratory complications, autonomic events and thromboembolism are all expected complications and need structured adverse event capture with onset, severity, seriousness and relationship, which the adverse event reporting workflow covers, including serious events and sign-off. Vital signs, particularly blood pressure management in acute SCI, sit on the vital signs template with ranges you define. Edit checks surface values for data managers; they are not a clinical alerting system.
Acute-care trials are usually multi-site, with different teams for emergency, intensive care and rehabilitation. QR-code enrolment, site-level participant numbering, a site coordinator portal and by-site exports keep this organised; see multi-site clinical trial management. Roles and PII segregation help when hospital staff, rehabilitation therapists and the sponsor all need different views.
Build sequence
A practical order of work for a sponsor or investigator team.
List each assessment against hours or days since injury and set windows to match.
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.
Typed motor and sensory fields, derived totals and an examiner field, with range checks on each score.
Representative signature first, participant confirmation later, with the protocol rules documented.
Windows and a record of contact attempts for later visits.
Run practice participants through every visit, then approve forms and go live.
Before first participant
Who performs the neurological exam and global outcome interview, and how consistency is checked.
Rights-holder terms filed in the study documents for any licensed scale.
Representative and deferred-consent rules approved by the ethics committee.
When a caregiver answers, and how the respondent is recorded.
CSV or Excel with the data dictionary opened in the statistics package.
Yes, as site eCRF forms with typed fields and derived totals. The licence or terms of any published scale stay with your study documents; Capture does not supply instrument wording or verify licences.
Yes. A trained staff member completes a site eCRF form from the interview, with a respondent field for participant or proxy, and the audit trail shows who entered it.
eConsent supports Legally Authorized Representative signature, an optional witness and investigator countersignature. Your protocol and ethics committee define who may sign and when the participant confirms later.
Yes. A repeating-row form on the site eCRF can hold date, duration and your own protocol fields, and each row carries its own audit trail.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with site-level numbering and by-site exports for multi-site work.
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 via the demo page or the pricing page.
Keep exploring
Software for rehabilitation research
Therapy and community studies.
EDC for CNS and neurology trials
The wider neurology view.
LAR consent software
Representative signatures.
MoCA eCRF template
Cognitive screening form.
EDC for tDCS and TMS studies
Stimulation session records.
Pricing
Free sandbox, pay when you go live.
Free sandbox with every feature. No credit card, and you pay only when you go live.