Clinical trial software for research nurses
The research nurse is the person at the bedside or clinic chair: taking timed vitals, giving the dose, drawing the samples, asking about symptoms and writing it all down. Capture gives that work forms that follow the visit, checks that catch a typo while the participant is still there, and an audit trail. Build free, no credit card.
- Timed observations at the visit
- Checks while the participant is present
- Every entry under your own login
Free sandbox · No credit card · 21 CFR Part 11 compliant
| Assessment | Pre-dose | 0 h | 1 h | 2 h | 4 h | Discharge |
|---|---|---|---|---|---|---|
| Vital signs | ||||||
| ECG | ||||||
| Investigational product given | ||||||
| Blood sample (time recorded) | ||||||
| Symptom check and adverse events | ||||||
| Concomitant medication review |
x = form completed at that time point
What a research nurse needs from trial software
- Forms in the order of the visit: pre-dose observations, dose, post-dose samples and symptom checks in the sequence the protocol runs them, not in the order a database was designed.
- Clock times that mean something: dose time, sample time and observation time are protocol data. Calculated fields can show the minutes between two date-times read-only, so a late sample is visible at the visit, not at monitoring.
- Entry-time checks: range and logic checks raise a query when a value breaks a rule, while the participant is still in the room and the value can be re-taken.
- Your name on your work: field-level audit trail records user, time, old value, new value and reason for change, which matters when several nurses cover one participant.
- Scope of delegation respected: what a nurse may do is set by the principal investigator on the delegation log; software roles should follow that, and causality and eligibility sign-off stay with the investigator.
The role
How the research nurse role differs from a coordinator or a nurse-led study
Search for software "for research nurses" and you meet two different jobs. The first is the study coordinator, who runs the site: feasibility, screening logs, scheduling, regulatory binders and sponsor correspondence. That work is covered in software for research coordinators. The second is the nurse who designs and leads the study, often a clinical academic, with wards or clinics as the unit of study; that is EDC for nursing research. This page is neither. It is for the clinical research nurse who delivers the protocol procedures to participants: the person who takes the blood pressure at minute 60, hangs the infusion, labels the tube, and rings the participant on day 3.
In many centres one person does several of these jobs, and titles vary by country and hospital. What matters for software is the task mix. A research nurse typically carries out procedures the principal investigator has delegated in writing, records what happened against source, recognises possible adverse events and escalates them, teaches participants to use diaries or devices, and keeps the visit within its window. ICH GCP places responsibility for the conduct of the trial, including medical judgements such as causality and eligibility, with the investigator, so a good setup makes it easy for the nurse to record an observation and flag it, and for the investigator to review and sign. The delegation itself lives in the site file; see the delegation log template for how sites usually document it.
Capture is a self-serve platform with role-based access, so the study administrator assigns each person a role and the audit trail attributes every entry to the individual login. Capture does not claim a dedicated research-nurse role; check that the roles available (researcher, site coordinator, admin) give your site the split of visibility you need, and test it in the free sandbox before the site initiation visit. Participant names are visible to site coordinators and hidden from researchers, who see coded IDs, so decide who at your site needs to see what.
Timed entries
Dose given at
EXSTTMBlood sample collected at
LBTMMinutes after dose
MINPOSTCalculated from two date-times, read-only
139 CalculatedProtocol window is 120 min +/- 10: out of window, add a note
Systolic blood pressure
SYSBPMean arterial pressure
MAPDerived from entered values
86 CalculatedNew symptom reported by participant
NEWSXYes: open the adverse event form
Day-to-day tasks
What a research nurse does in a visit and where it lives in Capture
| Nurse task | What gets recorded | Where it lives in Capture |
|---|---|---|
| Consent discussion | Information given, questions answered, signature, countersignature | eConsent: participant signs on screen with email OTP; authorised site staff countersign with password re-authentication |
| Screening and eligibility | Inclusion and exclusion answers, screening measurements | Eligibility screening form; the investigator confirms eligibility |
| Vitals and ECG | Position, rest period, values, time | Vital signs form with read-only calculations; QTc calculator for reference |
| Dosing and dispensing | Dose, time, lot or kit, deviations | Dosing form per visit; kit-based dispensing and randomisation where the study uses it |
| Sampling | Collection time, tube type, processing time, missed or haemolysed samples | Sample form with date-time fields and a calculated interval |
| Symptom calls and adverse events | Onset, severity, action taken, outcome | Adverse event form and the SAE workflow |
| Concomitant medicines | Name, dose, start, stop, indication | Repeating-row medications form, each row with its own audit trail |
| Diary and device teaching | Training given, first diary entry, issues | Participant questionnaire on their phone; see patient diary software |
Capture does not connect to hospital records, bedside monitors or laboratory systems. Values are entered by site staff from source documents.
Walk a nurse through a visit before the first participant
Build the dosing visit, enter sample data as a nurse would, and see which checks fire. Free sandbox, no credit card.
Where visit data goes wrong
Late entry, source transcription and the shift handover
The commonest data-quality problem at a busy research unit is not a wrong number, it is a number entered hours later from a scribbled sheet. Late entry matters because time-stamped procedures drift: the nurse remembers the dose time but not whether the 2-hour sample was taken at 1:52 or 2:07. Practical habits help more than software: keep a source worksheet at the bedside, record the clock time when you do the thing, and enter the form before the participant leaves if the protocol allows. Where the protocol window is tight, put the window in the form hint and let a check raise a query when it is missed, so the explanation is written by the person who knows it.
Shift handover is the second trap. When two nurses cover one inpatient stay, observations and adverse events can be recorded twice or not at all. Because every entry carries the signing user and time, and repeating rows keep their own audit trail, a monitor can reconstruct who recorded what. Agree a rule for who owns the adverse event log during an overnight stay, and write it into the site working instructions. Source data verification can be set per field, so the high-risk fields (dose time, eligibility answers, serious adverse events) can be prioritised for the monitor.
Finally, think about the participant. A nurse who also asks the participant to complete a symptom questionnaire on their phone should know what the participant will see. Preview it in the sandbox on a phone-sized screen. For the wider site workflow, including who sees what in a multi-site study, see role-based access control in clinical trials, and for an investigator-side view, EDC for clinical trial investigators.
Setup
Preparing your site for a nurse-run visit schedule
- 1
Map the delegated tasks
List each procedure on the schedule and who is delegated to do it on the site delegation log.
- 2
Build the visit forms in clinic order
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder draft visits and forms. A person reviews it; nothing is saved without review.
- 3
Add time windows and checks
Put protocol windows in hints, add range checks for vitals, and add a check for missing sample times.
- 4
Test as each user
Sign in as nurse, coordinator and investigator in the sandbox. Confirm who sees participant names and who can approve.
- 5
Dry-run a visit
Enter a full mock visit against the time stamps on a practice worksheet and fix awkward form order.
- 6
Approve and go live
Approved forms are locked for live use. Real participants start the paid live phase.
Before first participant
Research nurse readiness checklist
Delegation log current
Every procedure you will perform is delegated in writing and your training is filed.
Time points and windows clear
Allowed windows for vitals, ECG and samples are in the form hints.
Source worksheet agreed
The paper or hospital record you will transcribe from is named for every field.
Escalation route written
Who you call for a possible serious adverse event, and how fast.
Sandbox visit rehearsed
A full dosing visit entered and checked with test data.
Diary teaching script ready
What you tell participants about their phone questionnaires and reminders.
Is this different from your page for research coordinators?
Yes. The coordinator page covers running a site: screening logs, scheduling and study tasks. This page covers the nurse who carries out timed clinical procedures on participants and records them. One person may do both jobs.
Is this the same as the nursing research page?
No. EDC for nursing research covers nurse-led studies, such as ward-level designs and staff as participants. This page is for nurses delivering a sponsor or investigator protocol at a site.
Can a research nurse assess causality of an adverse event?
That depends on your protocol, local law and the delegation log; ICH GCP places medical judgements with the investigator. Capture records who entered each assessment and any later change, but it does not decide who is allowed to assess.
Can I enter data at the bedside?
Capture runs in a browser, so any device that can open it can be used where your site allows it and has a connection. Offline entry is not claimed, so keep a paper worksheet as source for rooms without reliable access.
Does it connect to our hospital system or lab system?
No integration is claimed. Site staff enter values from source documents, and a calculated field shows derived values such as minutes between two times.
How does a nurse sign off a visit?
Forms move through draft and approved states, and each entry is attributed to the signing user in the audit trail. Investigator sign-off steps follow your study setup.
What does it cost to try?
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants; plans are on the pricing page.
Keep exploring
Related pages
Software for research coordinators
Running the site day to day.
EDC for nursing research
Nurse-led, ward-level designs.
EDC for clinical trial investigators
The investigator view.
Adverse event reporting software
Adverse event and SAE workflow.
Edit checks software
Catch errors at entry.
Vital signs template
Timed observations form.
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