A trial master file that shows what is missing before anyone asks.

An electronic trial master file is the system that holds the essential records of a clinical trial and shows, for each record, who filed it, who approved it and what changed. AQ eTMF files those records to the CDISC TMF Reference Model by study, country and site, tracks completeness against what the study expects, and keeps an immutable audit trail on every document.

An electronic trial master file is the system that holds the essential records of a clinical trial and shows, for each record, who filed it, who approved it and what changed. AQ eTMF files those records to the CDISC TMF Reference Model by study, country and site, tracks completeness against what the study expects, and keeps an immutable audit trail on every document.

The eTMF is the sponsor’s file for the whole trial. The eISF is each site’s own file. AQ eTMF and AQ eISF share one study record, so site documents index into the TMF as the current version, and sponsor and site hold one record of each document.

The eTMF is the sponsor’s file for the whole trial. The eISF is each site’s own file. AQ eTMF and AQ eISF share one study record, so site documents index into the TMF as the current version, and sponsor and site hold one record of each document.

AQ eTMF creates a placeholder for every document the study expects, from study-defined lists and milestones. Completeness is the share of placeholders filled with a document that has passed QC, shown by trial, country, site and zone with RAG status, alongside timeliness and quality scores.

AQ eTMF creates a placeholder for every document the study expects, from study-defined lists and milestones. Completeness is the share of placeholders filled with a document that has passed QC, shown by trial, country, site and zone with RAG status, alongside timeliness and quality scores.

AQ CTMS and AQ eTMF share one study record, so the study, sites and milestones reach the TMF directly. A CTMS from another supplier needs an interface, and an interface between two validated systems is itself a computerised system that needs its own validation evidence. An open API for other suppliers’ systems is in development.

AQ CTMS and AQ eTMF share one study record, so the study, sites and milestones reach the TMF directly. A CTMS from another supplier needs an interface, and an interface between two validated systems is itself a computerised system that needs its own validation evidence. An open API for other suppliers’ systems is in development.

The best eTMF software for UK clinical research files to the TMF Reference Model, tracks completeness continuously, gives MHRA inspectors read-only access to the live file and states where its data sits. Ask every supplier for validation evidence for the release you will use. AQ eTMF meets the first four, and keeps the platform and study record in Microsoft Azure UK regions with DSPT Standards Met for 2026.

The best eTMF software for UK clinical research files to the TMF Reference Model, tracks completeness continuously, gives MHRA inspectors read-only access to the live file and states where its data sits. Ask every supplier for validation evidence for the release you will use. AQ eTMF meets the first four, and keeps the platform and study record in Microsoft Azure UK regions with DSPT Standards Met for 2026.

Look for a reference-model structure, expected document lists, version control with locked final documents, duplicate detection, QC routing with queries, electronic signatures with meaning captured, an immutable audit trail, and retention controls with legal hold. AQ eTMF holds all of these on the same record as the site file, the pharmacy file and CAPA.

Look for a reference-model structure, expected document lists, version control with locked final documents, duplicate detection, QC routing with queries, electronic signatures with meaning captured, an immutable audit trail, and retention controls with legal hold. AQ eTMF holds all of these on the same record as the site file, the pharmacy file and CAPA.

AQ eTMF gives inspectors scoped, read-only, time-limited access to the live TMF and logs every document they open or download. Readiness scores show completeness, quality, open queries and overdue gaps for each trial and site, and an archive export carries an integrity manifest for each file.

AQ eTMF gives inspectors scoped, read-only, time-limited access to the live TMF and logs every document they open or download. Readiness scores show completeness, quality, open queries and overdue gaps for each trial and site, and an archive export carries an integrity manifest for each file.

Yes. AQ eTMF scopes filing, completeness and access to study, country and site, and every CRO files to the sponsor’s structure. Coordinating centres in hub-and-spoke networks see every site in one view while each site works in its own record.

Yes. AQ eTMF scopes filing, completeness and access to study, country and site, and every CRO files to the sponsor’s structure. Coordinating centres in hub-and-spoke networks see every site in one view while each site works in its own record.

The sponsor and the chief investigator of a clinical trial of an investigational medicinal product keep the trial master file for at least 25 years, starting the day after the trial ends. Regulation 31A of the UK clinical trials regulations sets this period, as amended from 28 April 2026. The sponsor keeps the file for at least 2 more years after a UK marketing authorisation is granted, where the trial supports that application when the 25 years run out. AQ eTMF supports 25-year retention with configurable retention policies, legal hold and destruction certificates.

The sponsor and the chief investigator of a clinical trial of an investigational medicinal product keep the trial master file for at least 25 years, starting the day after the trial ends. Regulation 31A of the UK clinical trials regulations sets this period, as amended from 28 April 2026. The sponsor keeps the file for at least 2 more years after a UK marketing authorisation is granted, where the trial supports that application when the 25 years run out. AQ eTMF supports 25-year retention with configurable retention policies, legal hold and destruction certificates.

The platform and study record are hosted in Microsoft Azure UK regions. AQ Platform holds DSPT Standards Met status for 2026 and Cyber Essentials certification. Access is role-based, and every action on a document sits in an immutable audit trail.

The platform and study record are hosted in Microsoft Azure UK regions. AQ Platform holds DSPT Standards Met status for 2026 and Cyber Essentials certification. Access is role-based, and every action on a document sits in an immutable audit trail.