A CRDC research network distributes clinical trial delivery across multiple NHS sites while concentrating governance accountability at the hub. AQ eISF and ePSF are built to give the hub that control: connecting site documentation, pharmacy accountability, and quality governance into one inspection-ready operating layer across every participating site.

Key Takeaways:

• AQ gives every CRDC spoke site one hub-controlled document structure — consistent across all ten sites from a single configuration point
• Document due dates calculate automatically per site initiation date — coordinators open the platform and see exactly what is required and when, without maintaining any tracker
• When a protocol amendment is distributed, the hub sees which sites have acknowledged and which have not — updated in real time as coordinators complete their tasks
• Every signature carries legal attribution, a timestamp, and a SHA-256 document hash. It gives sponsors and MHRA inspectors tamper-proof evidence for every document across the network
• Hub governance leads get a live readiness score, overdue feed, and site comparison matrix across all ten sites. No manual reporting or monitoring visit needed.
• Pharmacy documentation, IP accountability, and dispensing records sit inside the same environment as the investigator site file. Sponsor monitors review everything in one place without requesting packages from site pharmacists
• Any document gap or pharmacy excursion raises a formal CAPA in the moment it is identified — linked to the triggering record, assigned immediately, and visible to the hub quality lead before the site has sent a single email
• Independent verification is enforced before any CAPA can close — every corrective action is confirmed effective, not just marked complete
• Each role — coordinator, quality lead, pharmacist, CRA — gets exactly the view they need without accessing records outside their governance scope
• A permanent, immutable audit trail runs across every site, every module, and every action. So, the network stays inspection-ready every day, not just before an MHRA visit

The Documentation Control Problem Specific to CRDC Research Networks

A CRDC hub is accountable for what happens at every spoke site — but in most networks, it cannot actually see what is happening in real time. Site coordinators maintain their own investigator site files locally. Pharmacy teams manage IP accountability in separate folders. Quality events get escalated by email. The hub finds out about a version gap or an open deviation only when a monitoring visit surfaces it, by which point the issue has often existed for weeks.

This is not a process failure. It is a structural one. When documentation, pharmacy records, and quality activity are managed in disconnected systems across ten sites, the hub has no mechanism for continuous oversight — only periodic reconstruction. AQ eISF and ePSF are designed specifically to close this structural gap: every site works within its own controlled environment, and the hub sees current status across all of them simultaneously, without manual outreach.

Also Read: What is a Clinical Research Delivery Centre (CRDC) and How Does Multi-Site Research Oversight Work?

How AQ eISF Is Built for Multi-Site CRDC Documentation Control

AQ eISF is not simply a digital filing software. It is a document control system built around the specific governance demands of a hub-and-spoke research network — where one hub must maintain oversight of document completeness, version currency, and signature status across ten sites simultaneously, without visiting any of them.

Hub-Controlled Templates Pushed to Every Spoke Site

The hub governance team builds one eISF template — the folder hierarchy, milestone plan, mandatory signers per document type, and notification rules — and applies it across all participating sites. Every spoke site inherits that structure when its binder is created. This means the hub defines what is required, how it is organised, and who is responsible for it across the entire network from a single configuration point.

Template structure in AQ eISF includes:

• Predefined CDISC TMF folder hierarchy — Protocol, Regulatory, Investigator and Staff, Informed Consent, Monitoring, Safety, and more
• Milestone plans assigned at template level — each milestone defines expected documents, due date formula, uploader role, signer role, and notification schedule
• Mandatory signer assignment — only users in the mandatory signers list see the sign option for each document
• Per-site or shared templates — hub can apply one template across all sites or configure per-site templates where the pharmacy hub flow or study scope differs
• Milestone Plan locked on assignment — once a plan is applied to a template it cannot be changed, preventing retrospective restructuring of document requirements

For Example, 

A research hub managing Study ONC-204 across eight participating sites creates an Oncology Phase II eISF template at the network level. As part of the study setup, the hub configures a Site Initiation Visit (SIV) milestone with a due date rule of Reference Date + 7 days.

The milestone is designed to ensure that essential start-up documentation is collected consistently at every participating site.

The SIV milestone automatically generates placeholders for:

• Approved Protocol
• Delegation Log
• Local Regulatory Approvals
• Staff CVs and Training Records

The hub team completes this configuration once within the template. No additional setup is required at individual sites.

As sites are activated, AQ eISF automatically calculates milestone due dates based on each site’s own initiation date.

For example:

Northshire University Hospital

• Site initiation date: 1 March
• SIV milestone due date: 8 March
• All required document placeholders created automatically
• Due dates assigned based on the site’s activation date

Riverside Cancer Institute

• Site initiation date: 15 March
• SIV milestone due date: 22 March
• Identical document placeholders created automatically
• Due dates calculated using the same milestone rule

Although both sites use the same template, each receives milestone schedules tailored to its individual study timeline.

The system automatically handles:

• Folder creation
• Document placeholder generation
• Milestone scheduling
• Due date calculations
• Site-specific timeline management

As additional sites join the study, the same rules continue to apply without further configuration from the hub team.

Key outcomes include:

• Single template configuration at hub level
• Consistent document requirements across all sites
• Automatic milestone generation
• Site-specific due date calculations
• Reduced study setup effort
• Standardized compliance tracking across the network

The hub configures the milestone structure once. AQ eISF applies the configuration automatically across every participating site binder.

Document Placeholders and Milestone-Driven Due Dates

A document placeholder is the mechanism through which AQ eISF makes document requirements explicit and trackable. Every expected document has a defined slot in the binder — with a name, due date, assigned uploader, signature requirement, and current status. The hub sees whether each slot is filled, pending, overdue, or waived across every site at any moment.

Placeholder statuses and what each means for hub governance:

Status	What It Means	Hub Governance Action Required
Pending	Document expected but not yet uploaded; due date has not passed	Monitor — no immediate action needed
Fulfilled	Document uploaded and linked to this placeholder	Review if signature is also required
Overdue	Due date passed without upload; automatic alert sent to site coordinator	Intervene — contact site or escalate
Awaiting Milestone Date	Placeholder linked to a milestone whose reference date has not yet been set	Confirm site initiation date to unlock
Waived	Marked not applicable with a recorded reason; excluded from readiness score	Review waiver justification for appropriateness

Due dates are not entered manually by site staff. They are calculated from a formula set at milestone level — Reference Date plus or minus a defined number of days, or relative to another milestone. A live preview in the milestone configuration shows the calculated date before publishing. This removes the single biggest source of due date inconsistency across sites: individual coordinators interpreting requirements differently.

Version Control and Per-Site Amendment Acknowledgement

Protocol amendments are among the highest-risk document events in a multi-site study. When a hub distributes an amendment by email, version risk accumulates immediately — sites acknowledge on different timelines, file different versions, and the hub has no structured way to confirm which version each site is actually operating on.

AQ eISF controls this through a structured distribution and acknowledgement mechanism:

• Hub governance team uploads the new version to the study binder — the system automatically creates a new version record, marks the previous version as superseded, and assigns acknowledgement requirements to every site binder
• Each site coordinator receives a task notification — they review the updated document, acknowledge receipt within their site binder, and upload a locally-signed version where the protocol requires it
• Hub dashboard updates in real time — acknowledgement status visible by site: confirmed, outstanding, approaching deadline
• Previous versions remain accessible and clearly labelled as superseded — no site can unknowingly operate on an old version without the hub seeing the gap immediately

For Example, 

Study ONC-204 receives an ethics-approved protocol amendment that updates participant follow-up visit schedules and assessment windows.

The governance team at Northshire University Hospitals, acting as the study hub, uploads Protocol v2.0 to the central study binder within AQ eISF. As soon as the new version is approved and published, the system automatically updates all participating site binders across the network.

The update process includes:

• Marking Protocol v1.0 as superseded
• Publishing Protocol v2.0 as the current approved version
• Creating acknowledgement placeholders for each participating site
• Tracking acknowledgement status centrally
• Monitoring due dates and overdue actions

The study network consists of eight participating sites. The hub team reviews the protocol acknowledgement dashboard and sees real-time status updates:

• Central City Hospital acknowledged Protocol v2.0 on the same day
• Greenfield Children’s Hospital acknowledged on Day 2
• Westbrook Medical Centre remains outstanding on Day 5
• Overdue alert automatically triggered for Westbrook Medical Centre

Because acknowledgement activity is tracked directly within AQ eISF, the hub team immediately identifies which site requires follow-up.

The hub quality lead contacts the study coordinator at Westbrook Medical Centre to verify that the updated protocol has been received and reviewed. Following confirmation, the coordinator completes the acknowledgement process and files the locally signed protocol acknowledgement record within the site binder.

Once completed, the dashboard automatically updates to reflect compliance across the network.

This process provides the hub team with:

• Centralized visibility of protocol adoption across all sites
• Automatic version control management
• Real-time acknowledgement tracking
• Overdue notifications for outstanding actions
• Complete audit trail of document distribution and acceptance

No email chains are required to monitor acknowledgements. No spreadsheets are required to reconcile responses. All protocol version control and acknowledgement activity remains visible within a single centralized system.

Electronic Signatures and Document Locking

Every signature in AQ eISF complies with 21 CFR Part 11 and UK eIDAS requirements. Signing is not a checkbox — it requires active re-authentication: the user’s password plus specific digits from their six-digit personal access code, randomly selected by the system each time. This position-based authentication means the access code cannot be shared or guessed from partial exposure.

What the system records at every signature event:

• User identity — name and registered email address
• Timestamp — date, time, and time zone to the second
• Document version — exactly which version was signed
• IP address — recorded in the immutable audit log
• Signature reason — Certification of True Copy, Document Certification, Compliance Attestation, or Other

Once a document has been signed by all mandatory signers, the system locks it. Locked documents are fully viewable in read-only mode but cannot be edited, replaced, or deleted without explicit unlock by an authorised user — which itself requires re-authentication and creates an audit trail entry. If the document needs updating after signing, a new version must be uploaded, which resets the signature requirement for that version and preserves the full history of the previous version.

▸  Example

At Clatterbridge Cancer Centre, the Principal Investigator Dr. Patel is listed as mandatory signer for the Delegation of Authority log under Study HEM-301. She opens the document in AQ eISF, clicks Sign, enters her password, and provides the 2nd, 4th, and 5th digits of her access code as prompted. The system records: Signed by Dr. Patel, 14 March 2026 09:41 GMT, document version DoA-v1.0, from IP 192.168.x.x. The document status changes to Approved and the system locks it. The hub governance lead sees the signature status update in real time on the Signatures dashboard — no confirmation email needed, no manual tracking required.

Certification of True Copy

For documents that require certified verification — scanned paper originals, externally sourced records, legacy documents being brought into the electronic system — AQ eISF provides a four-step Certification of True Copy wizard aligned with ICH-GCP E6(R3) and 21 CFR Part 11.

The four steps:

1. Review Document — certifier confirms they have fully reviewed the document
2. Confirm Completeness — system displays the Document Name, Version, Document ID, and SHA-256 hash for the certifier to verify
3. Declaration — certifier reads and accepts the full compliance declaration
4. Sign and Certify — certifier selects a signature reason and authenticates with password and access code digits

The SHA-256 hash creates a fingerprint of the document at the moment of certification. If the document is ever modified after certification, the hash will no longer match — making any tampering immediately detectable. For MHRA inspections, this provides a mathematically verifiable chain of custody for every certified document in the binder.

What the Hub Sees — The Cross-Site Readiness Dashboard

The hub’s Command Centre dashboard is the operational control surface for network-wide oversight. It aggregates document status across every participating site in real time — no manual updates from site teams, no email requests, no waiting for a monitoring visit.

Dashboard View	What It Displays	Primary User
Command Centre	Document readiness %, signatures complete, overdue count, at-risk items, due forecast — all sites combined	Hub Governance Lead
Cross-Site Readiness Matrix	Milestone-by-milestone status (complete / in progress / missing / overdue) for every site — colour-coded	Hub Governance Lead, Research Director
Signatures View	Signature completion by role across all sites; documents filed but still awaiting mandatory signatures	Research Governance Manager
Inspection Readiness Score	Real-time completeness score per site: proportion of placeholders Fulfilled or Waived	CRDC Research Director
Missing Required View	All unfulfilled placeholders by site and milestone, with overdue flag	Hub Governance Lead
Overdue and At-Risk Feed	Items past due date and items approaching due date across the network — flagged for immediate action	Research Governance Manager
Site Comparison View	Sites ranked by document readiness %; cross-site milestone matrix; filter by study, category, or repository type	Research Director, Quality Lead

▸  Example

It is Monday morning. The Hub Governance Lead at Liverpool University Hospitals opens the Command Centre for Study HEM-301. She sees: Document readiness 82% (112 of 137 filed). Signatures complete 76% (84 of 110). Overdue: 7 items. She opens the Site Comparison View. Mersey Care is at 55% — the lowest in the network, with 3 missing required documents and an overdue monitoring report. The Walton Neuro Centre is at 68%, with the ICF placeholder outstanding and no monitoring visit record filed. She opens the Overdue and At-Risk feed, filters to these two sites, and assigns resolution tasks directly within the platform. Both site coordinators receive task notifications before 9am. No phone calls. No email chains. No manual spreadsheet.

CAPA Triggered Directly From a Document Issue

AQ eISF is directly integrated with the CAPA module. When a hub governance lead or quality lead identifies a document issue — an overdue placeholder, a superseded version in use, a missing signature — they can raise a CAPA directly from the document record without leaving the eISF environment. The CAPA is automatically linked to the triggering document, pre-populated with the source type, and assigned to the responsible investigator.

What this means operationally:

• No separate system to log quality issues — the CAPA is raised from the exact document that triggered it
• The link between the document and the quality investigation is permanent and auditable
• Hub quality teams see the CAPA status alongside the document status in one governance view
• If the same issue appears at another site, the quality lead can cross-reference CAPA records across the network to identify whether a systemic preventive action is needed

Also Read: What is eISF: Electronic Investigator Site File in Clinical Research

How AQ ePSF Is Built for Multi-Site Pharmacy Documentation and IP Accountability

Pharmacy documentation in a CRDC network carries specific regulatory exposure. Investigational product accountability is a requirement under UK Clinical Trials Regulations and MHRA GCP expectations — and in most networks, pharmacy records exist in local files that the hub cannot access remotely, cannot cross-reference with investigator site records, and cannot confirm without requesting document packages from individual site pharmacists. AQ ePSF is built to bring pharmacy documentation inside the same inspection-ready environment as the eISF — so that pharmacy accountability is visible to hub governance teams alongside document readiness in one connected view.

Pharmacy File Structure Within the Same Environment as eISF

AQ ePSF uses the identical template-driven, milestone-based architecture as the eISF but configured with pharmacy-specific folder definitions. The Folder Library comes pre-loaded with the standard pharmacy folders a CRDC network requires:

• Controlled Drugs Licence
• Pharmacy Manual and SOPs
• Investigational Product accountability logs — per study and per site
• Dispensing records linked to participant and visit
• Storage condition documentation and temperature logs
• Pharmacy authorisations and role assignment records
• IP returns and reconciliation records

Hub administrators can extend the Folder Library at any time to meet study-specific or network-specific requirements — adding custom pharmacy folders without rebuilding the template from scratch. Because ePSF exists within the same platform as eISF, the hub governance lead sees pharmacy readiness alongside document readiness in one dashboard view, filtered by eISF, ePSF, or combined.

For Example, 

The research hub at Northshire University Hospitals creates an ePSF template for Study ONC-204. The template is designed to standardize pharmacy documentation and milestone tracking across all participating sites.

The template includes the following predefined milestones:

• Drug Receipt Milestone at study initiation
• Dispensing Milestone repeated for each participant visit cycle
• Temperature Monitoring Review Milestone scheduled monthly
• Drug Reconciliation Milestone at study close-out

Each milestone contains associated folders, document placeholders, due dates, and completion requirements.

When Riverside General Hospital joins the study network, an ePSF binder is automatically generated from the approved template. The system immediately provisions:

• Standardized folder structure
• Required pharmacy document placeholders
• Site-specific milestone schedule
• Expected completion dates
• Pharmacy readiness tracking metrics

The site pharmacy team begins uploading documents and completing milestone activities within the newly created binder.

As study start-up progresses, the hub pharmacy lead monitors readiness through the centralized site comparison dashboard. Without requesting updates by email or collecting status reports from the site pharmacist, the dashboard provides a real-time overview of binder completion.

The readiness view shows:

• Pharmacy readiness score of 88%
• Drug receipt documentation completed
• Storage qualification records uploaded
• Delegation records approved
• Two outstanding milestone tasks awaiting completion

This allows the hub pharmacy lead to assess site preparedness before the first monitoring visit and identify any remaining actions that require attention.

Key benefits demonstrated in this example include:

• Automatic ePSF binder creation from approved templates
• Consistent folder structures across all sites
• Standardized milestone scheduling
• Real-time pharmacy readiness monitoring
• Reduced administrative follow-up between hub and site teams
• Improved oversight across multi-site studies

IP Accountability Across Hub and Spoke — The Full Movement Chain

Investigational product accountability in a multi-site CRDC requires tracking drug movement from the central hub pharmacy through to each spoke site, and from each spoke site through to individual participant dispensing events. AQ ePSF manages this movement chain within structured, version-controlled records:

IP Event	What AQ ePSF Captures	Who Records It
Drug receipt at spoke site	Shipment details, batch number, quantity received, storage requirements, and responsible pharmacist	Spoke site pharmacist
Storage and inventory tracking	Temperature logs, storage condition records, stock level updates — version-controlled and timestamped	Spoke site pharmacy team
Dispensing event	Participant ID, visit number, dose dispensed, dispensing date, responsible pharmacist — each linked to the study protocol	Spoke site pharmacist
Returns and reconciliation	Returned quantities recorded against dispensed totals; reconciliation record generated per cycle	Spoke site pharmacist, reviewed by hub
Hub-to-spoke drug movement	Transfer records from hub pharmacy to spoke site — quantity, batch, transfer date, authorising pharmacist	Hub pharmacy lead (roadmap item co-designed with CRDC)

▸  Example

A shipment of Study HEM-301 investigational product arrives at Clatterbridge Cancer Centre. The site pharmacist logs receipt in the ePSF: batch HEM-B0047, 24 vials, stored in Refrigerator Unit 3 at 4°C, received 18 March 2026, signed by pharmacist R. Okafor. Three days later, Participant 012 attends Visit 3. The pharmacist dispenses 1 vial, records: Participant 012, Visit 3, 21 March 2026, vial from batch HEM-B0047, dispensed by R. Okafor. The hub pharmacy lead opens the ePSF dashboard for Clatterbridge and sees: 24 vials received, 1 dispensed, 23 remaining. The IP accountability record is current and complete without any report being requested from the site.

Temperature Excursion Capture and the CAPA Trigger From ePSF

Temperature excursions represent one of the highest-risk pharmacy events in a clinical trial — they directly affect IP integrity and participant safety. In most networks, an excursion is reported by email, logged in a local spreadsheet, and escalated manually to the hub quality team. The time between detection and formal quality investigation is measured in days, not hours.

In AQ ePSF, a temperature excursion is captured as a structured record — storage unit, temperature reading, time and duration of excursion, affected batches, and responsible pharmacist — and triggers a CAPA directly from within the pharmacy record. The CAPA is created in the moment, linked to the ePSF excursion record, and visible to the hub quality lead immediately.

For Example,

At 06:15 on a Tuesday, the temperature monitoring system at The Walton Neuro Centre identifies a refrigerator excursion. Refrigerator Unit 2 reaches 9°C for 47 minutes, affecting batch HEM-B0031 containing 8 investigational product vials.

At 07:30, the site pharmacist documents the event in the ePSF. The excursion record captures all relevant information, which includes:

• Storage unit affected (Unit 2)
• Temperature excursion curve and monitoring data
• Duration of excursion (47 minutes)
• Affected batch number (HEM-B0031)
• Quantity impacted (8 vials)
• Immediate containment action (product quarantine)

The pharmacist then initiates a CAPA directly from the excursion record. The system automatically generates a linked deviation record with the following details:

• Source Type: Deviation
• Risk Level: Critical
• Site: The Walton Neuro Centre
• Linked Record: ePSF Temperature Excursion
• Assigned Investigator: Site Quality Lead

Within minutes, the hub quality lead at Liverpool University Hospitals can see the newly raised CAPA in the network-wide CAPA dashboard. She reviews the excursion details, confirms that the quarantine action was appropriate, and assesses potential wider impact across the research network.

The review identifies that the same refrigerator model is currently used at two additional spoke sites. To mitigate future risk, the quality lead extends a preventive action across the network.

Preventive actions assigned through the same CAPA workflow include:

• Refrigerator calibration verification at Mersey Care
• Refrigerator calibration verification at Warrington and Halton
• Documentation of calibration outcomes
• Confirmation of equipment suitability for ongoing storage activities

Each site receives its assigned corrective action task within the CAPA workflow, allowing progress tracking, completion monitoring, evidence collection, and centralized oversight from the hub quality team.

This approach transforms a single-site temperature excursion into a network-wide quality improvement activity, ensuring rapid containment, consistent oversight, and proactive risk reduction across all participating sites.

Shared-Care Patient Folders and Hub-to-Spoke Pharmacy Flow

For studies where participants may be treated at more than one site — receiving part of their care at the hub and part at a spoke — pharmacy documentation becomes particularly complex. Dispensing records, storage oversight, and IP accountability must follow the participant across sites without creating duplicated or fragmented records.

AQ is co-designing shared-care patient folders with the CRDC specifically to address this. The functionality will allow:

• A single participant pharmacy record accessible to both the hub and the relevant spoke site — with role-based visibility controlling what each site can see and edit
• Hub-to-spoke IP transfer records linked directly to the participant’s dispensing history
• Dispensing events at either site recorded within the same structured accountability log
• Reconciliation at study close-out covering all sites within the participant’s pharmacy record

This directly addresses one of the CRDC’s named operational priorities — controlled pharmacy-file distribution and oversight across the network — and is being developed as a roadmap item within the active AQ-CRDC partnership.

What the Hub Sees — Pharmacy Readiness Alongside Document Readiness

Because ePSF sits within the same platform as eISF, the hub does not need to switch systems or request reports to see pharmacy status. The same Command Centre dashboard that displays document completeness can be filtered to show ePSF readiness, eISF readiness, or a combined view across both.

For a sponsor monitor preparing for a visit across three CRDC sites, this means:

• IP accountability records — confirmed current without requesting packages from site pharmacists
• Dispensing logs — reviewed against reconciled totals within the same platform used to check consent form versions
• Temperature excursion records — visible with full audit trail and linked CAPA status
• Pharmacy authorisations — confirmed current and signed by the responsible pharmacist
• Any open pharmacy-related CAPAs — visible alongside the site’s document CAPA status in the hub quality dashboard

Also Read: What is ePSF in Clinical Trial Data Management?

How CAPA Connects eISF and ePSF Into One Quality Control Layer

eISF and ePSF provide the documentation and pharmacy governance layers. CAPA is the quality investigation layer that sits on top of both — triggered by issues that either module surfaces, structured through a formal eight-stage lifecycle, and visible to hub quality teams across the entire network. Together, the three modules ensure that a documentation gap or pharmacy event does not remain an operational problem. It becomes a quality record: investigated, actioned, verified, and closed with evidence.

AQ CAPA is not a ticketing system. Each stage in the lifecycle has formal entry and exit conditions enforced by the system — a CAPA cannot move to Implementation until an Action Plan has been approved by a designated approver, and it cannot close until an independent verifier records an Effective outcome.

Stage	What Happens	Who Is Responsible
Open	Issue recorded and confirmed as valid; risk level and source type assigned; target completion date set	CAPA creator (QA staff, quality lead, or investigator)
Under Investigation	Assigned investigator examines the issue — reviews evidence, builds factual account of what happened	Assigned investigator
Under RCA	Root cause analysis conducted using selected method — 5 Whys, Fishbone, Pareto, or Fault Tree	Assigned investigator
Action Planning	Corrective and preventive actions defined, assigned to named staff with start and end dates	CAPA owner and assigned staff
Approval	Designated approver reviews the action plan and confirms it is proportionate and safe to proceed	CAPA approver (QA manager or quality lead)
Implementation	Assigned staff carry out the actions; each task evidenced individually within the Tasks tab	Action owners
Verification	Independent verifier confirms actions were completed and effective — must be someone separate from implementers	Independent verifier
Closure	CAPA owner records final remarks and formally closes; Effective = resolved; Not Effective = reverts to Action Planning	CAPA owner

Every stage transition requires re-authentication. The system records who authorised each step, when, and in what capacity — creating a legally-weighted audit trail from issue detection to verified closure.

Not Effective triggers an automatic reversion. If the verifier records a Not Effective outcome, the CAPA reverts to Action Planning automatically. The team revises the plan, re-submits for approval, implements, and re-submits for verification. This cycle repeats until the root cause is genuinely resolved — and every iteration is permanently recorded.

Also Read: The Ultimate Guide to What is CAPA Management in Clinical Trials

What Each Role Actually Does Inside AQ eISF and ePSF Across the Network

Hub Governance Lead

The hub governance lead opens AQ each morning to a dashboard that shows the current state of the entire CRDC network without having contacted anyone. She filters the Site Comparison View to see which sites have fallen below 80% document readiness, opens the Overdue and At-Risk feed to identify any placeholder now three or more days past its due date, and checks the CAPA dashboard for any open quality actions approaching their target completion date. When she identifies a gap — an outstanding amendment acknowledgement at Warrington and Halton, a missing delegation log at Mersey Care — she raises a task notification within the platform. The site coordinator receives it before their morning briefing. If a gap represents a quality risk, she raises a CAPA directly from the relevant document record. By the time she attends the weekly CRDC governance call, the dashboard has already provided her with the evidence base for every site-level discussion.

Research Coordinator at a Spoke Site

The research coordinator at Alder Hey Children’s logs into AQ and sees her task list for the day: one overdue placeholder for a staff CV renewal, two documents awaiting her acknowledgement following last week’s protocol amendment, and a signature required on the updated delegation log. She works through the list within her site binder — uploading the CV, acknowledging both amendment documents, and signing the delegation log with her password and access code. She does not navigate multiple systems, chase colleagues by email, or maintain a parallel tracking spreadsheet. Her actions update the hub dashboard automatically. The hub governance lead sees Alder Hey’s readiness score move from 86% to 92% by midday.

Quality Lead

The quality lead at the hub receives a system notification that a new CAPA has been raised at The Walton Neuro Centre — a temperature excursion in the ePSF, Risk Level Critical. She opens the CAPA record, reviews the excursion details linked directly from the ePSF, confirms the site quality lead has been assigned as investigator, and checks whether the same refrigerator model is in use at other sites by reviewing ePSF records at Mersey Care and Warrington and Halton. She extends the preventive action scope to both sites within the same CAPA record. She does not send an email to three site quality leads and wait for responses. She assigns tasks, sets due dates, and monitors completion from the CAPA dashboard — where she can also see the two open document-related CAPAs from last month and their current stage across the network.

Pharmacy Staff

The pharmacist at Clatterbridge Cancer Centre manages Study HEM-301 IP accountability entirely within the AQ ePSF binder. Each drug receipt is logged with batch number, quantity, and storage conditions. Each dispensing event is recorded against the participant and visit. Temperature logs are uploaded weekly. When a batch approaches expiry, the system flags it with an alert. When the sponsor monitor requests an accountability review before the next visit, the pharmacist does not prepare a document package — the monitor accesses the ePSF records remotely through the same platform, with full dispensing history, storage records, and reconciliation data available in one view. The hub pharmacy lead can also see Clatterbridge’s pharmacy readiness alongside its eISF readiness in the hub dashboard without requesting anything from the site.

Sponsor Monitor / CRA

The sponsor monitor preparing for a monitoring visit to Liverpool Women’s logs into AQ two weeks before the visit date. She opens the site comparison view and reviews Liverpool Women’s against the network average — document readiness 90%, pharmacy readiness complete, one open CAPA (ICF v1.0 issue, now in Verification stage). She reviews the eISF binder directly: checks the amendment acknowledgement log, confirms delegation records are current, opens the audit trail for the Informed Consent folder to verify the re-filing actions. She reviews the ePSF: dispensing logs are reconciled to visit 6, storage records current, no open pharmacy excursions. She arrives at the monitoring visit with a current, evidence-based view of the site’s compliance status. The visit does not require emergency preparation from the site team because the records were maintained continuously — not assembled for her arrival.

What the Audit Trail Captures and Why It Matters at Inspection

When an MHRA inspector arrives at a CRDC spoke site, they are not looking for a complete filing cabinet. They are looking for evidence that every action was taken by the right person, at the right time, using the right document version — and that any deviation from the expected process was formally identified, investigated, and resolved. AQ eISF and ePSF capture exactly this evidence, automatically, as a function of daily operations.

Action Type	What eISF Captures	What ePSF Captures
Document upload	User identity, timestamp, document version, folder path, linked placeholder	Pharmacy record upload, batch reference, storage unit, responsible pharmacist
Version update	Previous version marked superseded, new version linked, change timestamp, user identity	Previous pharmacy record version archived, new version linked with update reason
Electronic signature	Signatory identity, timestamp, document version, IP address, signature reason, access code digit positions used	Pharmacy authorisation signatory, timestamp, document version, role at time of signing
Document lock	User who locked, timestamp, reason, document version at point of lock	Pharmacy record lock — prevents editing of reconciled or verified records
Amendment acknowledgement	Site coordinator identity, acknowledgement timestamp, document version acknowledged, placeholder status update	Pharmacy amendment acknowledgement, version confirmed, responsible pharmacist
CAPA lifecycle transition	User who authorised transition, stage from and to, timestamp, re-authentication confirmation	CAPA transitions linked to ePSF excursion record — full chain from detection to closure
Document removal	User who removed, timestamp, reason provided, destination archive, restoration option preserved	Pharmacy record removal — archived with full history; permanent deletion not supported

No entry in either audit log can be edited, deleted, or backdated. Every record is immutable from the moment it is created. For MHRA inspections, this means the inspector sees the actual sequence of events — not a reconstructed account. For sponsors, it means monitoring evidence does not depend on site staff memory or paper records that may have been lost or misfiled. The audit trail is the inspection record.

AQ applies a 25-year archiving retention control aligned with MHRA requirements. No document and no CAPA record is permanently deleted. Removed items are archived with full audit history and can be restored by an authorised user — with that restoration itself recorded in the audit trail.

Also Read: Clinical Research Audits: Types, Process, Checklist, and Audit Readiness Guide

Regulatory Foundations Underpinning AQ eISF and ePSF

AQ eISF and ePSF are aligned with the regulatory frameworks that govern multi-site NHS clinical research. The platform does not claim certification against these frameworks. It is built and configured to support compliance with them through system-level controls.

Framework	What It Governs	How AQ eISF and ePSF Are Aligned
ICH-GCP E6(R3)	Essential documents, site governance, quality management in clinical trials	Template-driven document structure, role-based controls, milestone-driven filing, and audit trail design aligned with E6(R3) expectations
UK Clinical Trials Regulations (April 2026)	Conduct, oversight, and documentation of clinical trials in the UK	Document governance, pharmacy accountability, and delegation controls structured for UK CT Reg compliance across hub and spoke sites
MHRA inspection expectations	Evidence of compliant research conduct at inspection	Continuous inspection readiness through real-time completeness scoring, milestone-driven filing, and integrated CAPA evidence — no reconstruction required
21 CFR Part 11	Electronic records and electronic signatures in regulated systems	Position-based two-factor authentication for all significant actions: signing, locking, lifecycle transitions, CAPA approvals
ALCOA+	Data integrity in clinical research records	Every action Attributable, Contemporaneous, Legible, Original, Accurate — enforced by system controls, not manual process
MHRA 25-year archiving	Long-term retention of clinical trial records	No permanent deletion; removed documents and CAPAs archived with full audit trail and restoration controls
NHS DSPT	Data security and protection in NHS digital systems	Platform aligned with NHS Digital Data Security and Protection Toolkit requirements
ISO 27001-aligned	Information security management	Access management, incident logging, and business continuity controls aligned with ISO 27001 expectations
Cyber Essentials / ICO ZB324099	UK cybersecurity baseline and data controller registration	Certified and registered — evidence available for technical and governance review as part of procurement due diligence
GxP / GAMP 5	Computerised system validation for regulated environments	Validation pack v1.6 and BCP v3.0 available for review; system released under validated change control

Also Read: What is AQ Platform: Clinical Research Software Modules, Use Cases, and Compliance Standards

Explore AQ eISF and ePSF for Your CRDC Research Network

AQ provides a connected research operating environment where eISF, ePSF, CAPA, CTMS, Digital DoA, and QMS operate within one platform across every participating site. Hub governance teams maintain real-time visibility. Spoke site teams work within role-based views that surface their active tasks and overdue requirements without navigating multiple systems. The platform is built around over 20 years of clinical research operations experience and aligned with ICH-GCP E6(R3), UK Clinical Trials Regulations, MHRA inspection expectations, ALCOA+, 21 CFR Part 11, UK GDPR, NHS DSPT, GxP computerised system validation, and GAMP 5.

AQ supports modular deployment — CRDCs typically start with eISF 2.0 across all sites and CAPA management at hub level, then expand to ePSF, CTMS, Digital DoA, and QMS at a pace that works for the network. Onboarding, training, and go-live support are included within the network commercial model, which treats all participating sites as a single operational unit rather than charging per site or per study.

Request a live demonstration. Speak with the AQ team to explore how AQ eISF and ePSF support CRDC and multi-site research operations through a live walkthrough of hub-and-spoke oversight, document governance, pharmacy accountability, and CAPA management across the network.