Hospital teams · Clinical auditUpdated October 9, 2026

Clinical audit data collection tool for QI projects that outgrow spreadsheets

An audit is only as good as the data behind it. Build a structured audit form with range checks and mandatory fields, collect across wards or sites, keep a trail of every change and export for the re-audit, without a spreadsheet passed round by email.

  • Structured forms and validation
  • Multi-site collection
  • Export for analysis and re-audit

Free sandbox · No credit card · 21 CFR Part 11 aligned

Hip fracture audit: admission to theatre
Case 014 · Ward 7 · Demo auditOpen query

Standard: surgery within 36 hours of admission

Date and time of admission

12-Mar-2027

Date and time of surgery

10-Mar-2027

Auto-query: surgery is before admission

Delay reason

None

Standard met

YesNo
Demo data. A date error caught at entry, not at the audit meeting

At a glance

  • Clinical audit measures practice against agreed standards, then acts on the gaps and re-measures. HQIP, which promotes clinical audit in England and Wales, describes it as a quality improvement cycle.
  • Under the HRA decision tool, research aims to produce new generalisable knowledge, while audit informs delivery of best care and service evaluation evaluates current care. Audit and service evaluation normally do not need REC review, but local approval still applies.
  • Capture is a clinical trial platform. For audit it offers structured forms, range and mandatory checks, multi-site collection, role-based access, an audit trail on every change and CSV/Excel export with a data dictionary.
  • Decide first whether the project is audit or research; Capture does not make that call. Involve your clinical audit, information governance or R&D office.
  • Pricing is published per participant per month (pricing); check how an audit "case" counts before you plan a large one.

The problem

Why audit data collection breaks down in spreadsheets

Most audits begin in a spreadsheet and most of the early time goes on cleaning it. Free-text dates arrive in three formats, one ward leaves a column blank, a second copy circulates by email and nobody can say which version was analysed. The standard might be clear, such as surgery within 36 hours of admission, but the data does not reliably show whether it was met.

The cost of this shows up at the audit meeting, when the team debates the numbers instead of the practice, and again at re-audit, when last year's method cannot be reproduced exactly. A structured form fixes the definitions once: the same fields, the same units, the same allowed values for every case, whoever enters them.

Capture was built for clinical research, so it already has the machinery a good audit form needs. The clinical trial software for quality assurance page covers the related quality-management angle, and EDC for registry studies shows the long-running, many-record pattern that audits resemble.

Governance first

Audit, service evaluation or research: decide before you collect

The Health Research Authority publishes a decision tool for classifying a project, and many NHS trusts point staff to it. The distinction rests mainly on purpose: research aims to derive new, generalisable knowledge; audit measures current practice against standards to inform care; service evaluation assesses what a service currently delivers. Research normally needs ethics review; audit and service evaluation normally do not. Even so, trusts expect local registration with the audit or governance team and a check on information governance, so do not treat "not research" as "no approval".

This page does not say which route your project takes, and a software tool does not change it. If the project turns out to be research, for example a prospective study designed to generalise, the same forms can serve a formal observational study, with consent where needed and the controls described on the platform page. If you are classifying a project, keep the decision tool output with your project file.

Setting it up

From audit standard to data collection form in five steps

  1. 1

    Write the standards as measurable criteria

    For each standard decide the numerator, denominator and exceptions, for example "surgery within 36 hours; exclude patients unfit for surgery with the reason recorded".

  2. 2

    Build one form per case

    Use the form builder or let the AI Study Builder draft fields from a description or uploaded sheet. Every field is reviewed by you before anything is saved. Use dropdowns and numeric fields rather than free text.

  3. 3

    Add edit checks

    Range and rule checks raise an auto-query when a value breaks a rule, such as surgery before admission, an age outside a plausible range or a missing mandatory field.

  4. 4

    Add collectors by role

    Give each ward or site coordinator access to their own cases and view-only access to reviewers. Role-based access and by-site filtering keep each team to its own data.

  5. 5

    Collect, check, export

    Monitor completion by site, resolve queries, then export CSV or Excel with the data dictionary for your analysis, and keep the form version for the re-audit.

What helps an audit

Audit needs matched to what Capture does

Audit needHow it is metNotes
Consistent definitionsStructured form with typed fields and dropdownsTen question types plus repeating table sections
Catching entry errorsEdit checks raise auto-queriesRange and custom rules, with priority
Several wards or hospitalsSite-level numbering and by-site filteringSeparate coordinator access per site
Who changed whatField-level audit trailTimestamp, user, old and new value, reason
Analysis and reportingCSV/Excel export with data dictionaryFilter by date range and site
Re-audit comparabilityApproved forms are locked for live useDraft, approve, then collect
Access controlRole-based accessCoded IDs for researchers, names only where needed

Capture does not replace your trust's information governance. Choose what patient identifiers you collect, and keep them to the minimum the audit needs.

Build your audit form and break it on purpose

Create the form in the free sandbox, enter a surgery date before the admission date and watch the auto-query fire. No credit card.

Build your audit form free

Data and cost

Data protection, hosting and what it costs

Audits often use identifiable patient data, so involve your information governance team early and collect the minimum. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia), and the security page lists the controls. You, as the organisation running the audit, remain responsible for the lawful basis and for who has access.

On cost, the pricing page is built for studies: Core is $1,000 a month with one live study, plus $50 per participant per month, and the study fee starts when the first participant is screened. For a short audit that fits a single quarter that can be modest, and the EDC per-patient pricing explained page shows how to compute it. An audit of several thousand cases is a different calculation, so talk to us before you plan it. Academic teams can also read the academia page.

You can build, test and rehearse the whole audit in the free sandbox first, with sample cases, and you pay only when you go live with real participants.

Before you start collecting

Audit data collection checklist

Project classified

Audit, service evaluation or research, with the decision tool output on file.

Local registration

Registered with the trust audit team; information governance consulted.

Standards defined

Numerator, denominator and exclusions written down.

Minimum identifiers

Collect only what the audit needs; use coded case IDs.

Form tested

Edit checks fire on bad values; reviewers tried the form.

Collectors trained and roles set

Each ward or site sees its own cases.

Re-audit planned

Same form version, same export, agreed date.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

Can Capture be used as a clinical audit data collection tool?

Yes, for structured case-level collection: typed forms, edit checks, multi-site access, an audit trail and CSV/Excel export. Capture is a clinical trial platform, so decide first with your governance team that the project is audit.

Does a clinical audit need ethics approval?

Under HRA guidance audit and service evaluation normally do not need REC review, whereas research does, but local registration and information governance approval still apply. Use the HRA decision tool and check with your audit or R&D office.

How do I make sure audit entries are accurate?

Use dropdowns and numeric fields, mandatory fields and edit checks that raise an auto-query when a value breaks a rule, such as a surgery date before admission.

Can several wards or hospitals use the same audit form?

Yes. Capture supports site-level participant numbering, separate coordinator access and by-site filtering and exports.

Can I export the data for analysis?

Yes. CSV or Excel exports include an automatic data dictionary and can be filtered by date range and site.

Is patient-identifiable data allowed?

That is a decision for your information governance team. Collect the minimum, use coded IDs where possible, and use the role-based access and PII segregation described on the platform pages.

What does it cost?

The pricing page lists Core at $1,000 per month plus $50 per participant per month, with the study fee starting at the first participant screened. Larger audits need a separate calculation, so ask us. The sandbox is free.

Data your audit meeting can trust

Build the audit form free, test the checks and collect across wards. You pay only once you go live.

Build your audit form free