Source worksheets lose version control long before inspection day.
Most UK sites hold source on paper worksheets or word-processor files, adapted from sponsor examples and revised by hand during each study. Control depends on file names and printed headers. Inspectors ask for the template in use on a given date, its approver and the reason for each change, and that evidence is scattered across email threads and shared drives.
Design, test and release source forms in AQ eSource.
Form Management lists every electronic source form in the organisation, with its published and draft versions, author and dates. Form Builder holds the design work, and each form moves from draft to published under a recorded reason.
Source forms beside the records inspectors check them against.
An inspector reviewing source also checks the person’s delegation and training, and whether the participant consented on the current form. AQ Platform holds those records today, and AQ eSource runs on the same platform.
What’s next, below, sets out how AQ eSource uses these records at the point of entry.
Visit capture, checked at entry against the site’s records.
Research staff still record observations on paper and key the same values into each sponsor’s EDC. AQ eSource moves that capture onto the released forms and checks each entry against the site’s own records at the moment it is made. The capabilities below are in development, and AQ product sets the timing of each release.
Capture at visits
Released forms open from each participant’s visit on desktop or tablet, with windows down to the minute and autosave every 30 seconds.
Contemporaneous by design
Observation and entry times are stored separately, late records carry a reason, and every prior value stays visible with its history.
Checks at entry
Forms carry ranges with units, warnings that need an override reason, investigator review of clinical significance and a coded not-done list.
Consent checked first
Observations timed before consent are rejected, and a new consent form version approved in AQ eISF flags participants for re-consent.
Deviations and logs
Out-of-window visits create a deviation record in AQ QMS, and adverse event and medication logs carry forward with a 24-hour serious-event clock.
Investigator visit sign-off
Principal investigators sign each visit with e-signature controls aligned to 21 CFR Part 11 and EU Annex 11, which locks it read-only.
Phase 1 units
Timepoints anchor to the actual dose time, with a cohort run sheet showing live countdowns and one-screen cohort grid entry.
Protocol amendments handled
An impact report shows what a new form version changes for studies in progress, with a recorded choice to keep or migrate.
Standard form library
Starter forms cover vitals, demographics, history, medications, adverse events, eligibility, ECG, safety labs, dosing and PK, each subject to medical approval.
The research teams that depend on controlled source forms.
Research offices
One controlled library of source forms across hosted studies, with every release attributed to a named user and a recorded reason.
Networks and SMOs
Standard worksheets built once in the organisation’s library and released under one attributed history, ready for each new study.
Pharmacy and laboratories
IMP receipt, dispensing, destruction and sample processing worksheets rebuilt as electronic forms that keep the site’s layout and document references.
Principal investigator oversight
Investigators can identify the version in use on any date, the person who released it and the documented reason.
Early-phase research units
Tables, time inputs and calculations reproduce dense Phase 1 sampling and observation sheets on A4 pages, ready for controlled release.
Sponsors and CROs
Sites can show monitors and auditors which form version was live on any date, who released it and why.
Source form controls aligned to UK GCP inspection expectations.
ICH E6(R3) calls for source records that are attributable, legible, contemporaneous, original, accurate and complete, under the investigator’s authority. Compliance with the ICH E6 GCP principles has been a legal requirement for UK trials of medicines since 28 April 2026, under Regulation 28 of the amended UK Clinical Trials Regulations. Trial records, including the investigator site file, must be kept for 25 years. AQ eSource is designed to support these requirements for the source forms themselves. Each release is attributed and carries a recorded reason, published versions are read-only, and the audit history can be exported.
Three steps from paper worksheets to released source forms.
List current templates
Record the source worksheets in use for each study, with their document references, owners, effective dates and approval route.
Rebuild and test
Recreate each worksheet on the A4 canvas, by hand or with AQ Assist, and test required answers, logic and calculations in preview.
Release under control
Publish each approved form with a recorded reason, then revise it later through a new draft version with its own history.
Guides on electronic source for UK research sites.
Frequently asked questions.
eSource is source data captured electronically at the research site, at or close to the time of the observation, in a system under the investigator’s authority. It replaces paper source worksheets and the transcription that follows them. The sponsor’s electronic case report form remains a separate record. AQ eSource covers the design and release of source forms today, and capture is in What’s next.
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