Digital Delegation of Authority that's always current, always provable.

AscensionQ Digital DoA replaces paper-based delegation logs with a structured, electronic system. Trial roles, responsibilities, and qualifications are recorded, signed, and tracked in real time — mapped to evidence like CVs, GCP certification, and training records.

21 CFR

Part 11
Compliant

ICH-GCP

Aligned
Documentation

Inspection

Data Integrity
Principles

FIG.01 — Live study mission control

REALTIME

Outdated or Disconnected DoA Systems Create Gaps in Study Responsibility Tracking

Delegation of Authority defines who is authorised to perform each study activity, but without a unified system-driven DoA, responsibility remains scattered across documents, systems, and teams — reducing clarity, weakening accountability, and
creating gaps in audit evidence.

No Single Source of Truth for Role Assignment

DoA records exist across paper logs, spreadsheets, eISF folders, and local trackers. Each source reflects a different version of delegation. Study teams lack one consistent view of assigned roles and responsibilities across the study.

Disconnection Between DoA and Study Activity

DOA logs remain separate from CTMS tasks, eTMF approvals, eISF documentation, and ePSF accountability records. Study actions do not carry a direct link to authorised roles, limiting visibility into who performed each activity.

Delayed and Inconsistent Updates After Role Changes

Staff transitions, added responsibilities, and study amendments require updates across multiple systems. Manual DoA processes do not keep delegation aligned with current team structure, creating mismatches between recorded and actual responsibility.

Limited Traceability of Responsibility During Audits

Disconnected DoA records do not maintain a complete, time- stamped history of role assignment and changes. Audit teams face difficulty verifying responsibility at specific points in time and linking actions to authorised personnel.

The solution: AQ Digital Delegation of Authority (DoA).

AQ Digital DoA solution turns delegation from a static document into a structured, real-
time process. With this you have a single, authoritative view of every team member’s
authorised tasks and qualifications, fully integrated with your training and study
management systems.

AQ Digital DoA Organises Role Assignment and Delegation Within One System

AQ Digital DoA brings role assignment, delegation logs, effective dates, and approvals into one connected system across CTMS, eTMF, eISF, ePSF, QMS, and CAPA — so every task, document action, and quality workflow reflects the correct authorised individual without manual cross-checking.

Role and Delegation Overview

All role assignments and delegation records remain centralised within AQ — investigators, coordinators, and oversight teams work from one consistent source of truth.

Activity and Role Alignment

CTMS tasks, eTMF approvals, site documentation, pharmacy actions, and CAPA ownership align with DoA records — each activity reflects the assigned and authorised role.

Real-Time Role Synchronisation

Staff onboarding, role updates, and study amendments reflect immediately across delegation records and connected modules — keeping responsibility aligned with current study operations.

Delegation History and Traceability

Time-stamped delegation logs, approval records, and role changes remain fully recorded — audit teams can verify responsibility and authorisation at any point in the study lifecycle.

Core Capabilities of AQ Digital DoA.

AQ Digital DoA is purpose-built to support the way clinical research teams actually
work, while making compliance simpler.

01 — DELEGATION MANAGEMENT

Digital Delegation Log

The AQ Digital DoA solution helps you create study- specific DoA logs in a few clicks. Every role, task, responsibility, and authorised user is captured in a structured digital format, removing the ambiguity of free-text logs.

02 — QUALIFICATION TRACKING

Linked Qualifications and Evidence

Each delegation entry is tied to underlying evidence such as CVs, GCP training, role-specific training, and other qualifications. Therefore, this shows not just who is delegated, but why they are qualified to take that role.

03 — COMPLIANCE SIGNING

21 CFR Part 11 Electronic Signatures

Investigators, sponsors, and authorised staff can sign delegations electronically using compliant e-signatures. AQ Digital DoA fully aligns with regulatory expectations and removes the need for printing, signing, and scanning.

04 — Collaboration

Role Access and Configuration

Configure tasks and roles per study or therapeutic area. Admins, PIs, and QA users see only what they need based on permissions, while staff can quickly view their own delegations.

05 — Access & Permissions

Cross-Study Oversight

AQ Digital DoA brings any change in delegation, irrespective of role, scope, or staff, into the system in real-time. With its built- in version history and audit trail, you can easily understand what changed, when, and by whom.

06 — DASHBOARDS & ANALYTICS

Audit-Ready Reports and Exports

AQ Digital DoA integrates directly with our QMS / training management. So, you can be 100% sure that delegations are aligned with current training status, expiring certificates, and qualification updates.

07 — ROLE GOVERNANCE

Cross-study oversight

Multi-site organisations can manage DoA records across manystudies and locations through a unified dashboard, with central monitoring of who is delegated where.

06 — Audits

Audit-ready reports and exports

Generate detailed DoA reports, audit trails, and historical views in seconds. Inspectors and sponsors get clear, structured documentation without the need for manual reconstruction.

How AQ Digital DoA Supports Role Clarity and Responsibility Across Research Teams?

Each user understands their assigned responsibilities, access scope, and approval authority within the study — supporting coordinated execution across investigators, coordinators, quality teams, and pharmacy staff.

NHS and Hospital Research Environments

Medical decisions, study procedures, and documentation approvals align with authorised investigators and staff across active trials, clinical duties, and regulatory oversight.

Academic and University Research Centres

Consistent role assignment across distributed teams, multiple investigators, and varying study structures — supporting coordination across departments.

Sponsors Managing Multi-Site Programmes

Visibility into who holds responsibility across sites, studies, and activities — supporting oversight of approvals, study conduct, and compliance across the research programme.

Contract Research Organisations (CROs)

Aligned responsibility across teams, sponsors, sites, and protocols — consistent delegation supports operational consistency and maintains accountability across study delivery.

Why Choose AQ Digital DoA for Clinical Research Responsibility and Delegation?

Unified Delegation Across the AQ Platform

Single DoA system applied across CTMS, eTMF, eISF, ePSF, QMS, and CAPA — consistent role assignment, permissions, and responsibility across all study functions.

End-to-End Responsibility Alignment

Delegation records remain directly connected to study tasks, document workflows, and quality actions — role ownership reflects actual execution across the study.

AI-Supported Role Monitoring and Insight

System intelligence highlights role gaps, outdated delegation, and responsibility
mismatches across studies — supporting earlier identification of issues within delegation management.

Easy Platform Deployment and Adoption

Flexible role structures, study- specific delegation setup, and scalable configuration support adoption across all research environments without disrupting existing workflows.

AQ Digital DoA Setup, Configuration, and Adoption

Supporting structured adoption across research teams managing active studies, evolving roles, and mixed systems — from the start, so role assignment, approvals, and responsibility tracking remain clear and consistent.

1
DoA Configuration Based on
Study Roles and Structure
Role definitions, study teams, and delegation requirements configured according to protocol, site structure, and organisational workflows.
2
Delegation Setup with Role
Assignment and Approvals
Assignment of investigators, coordinators, and staff with defined responsibilities, supported by controlled approval and signature workflows.
3
Training and Onboarding for
Research Teams
Guided sessions and platform walkthroughs for investigators, coordinators, quality teams, and pharmacy staff to ensure confident use of delegation workflows.
4
Implementation Support
During Transition
DStructured support to align existing DOA logs, spreadsheets, and paper records within the AQ system while maintaining continuity across active studies.

Request Live Demo of DoA

Let us walk you through how AQ clinical research software manages role assignment, delegation, and responsibility across study operations, documentation, and quality processes. See how AQ Digital DoA keeps roles aligned with real study activity, so your teams work with clear authority, consistent delegation, and audit-ready records across every study.

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Key Questions Beyond Software Features

What is a digital delegation of authority (DoA) log?

A delegation of authority (DOA) log records who is authorised to perform which trial tasks, when that authority started and ended, and who approved it. AQ Digital DOA turns the static paper log into a live control layer, connecting role assignment, effective dates, approvals, signatures, training and system access to the study record.

AQ Digital DoA captures effective start and end dates, routes assignments for approval and electronic signature, and maintains time-stamped role history. Teams can prove who was authorised, for what, at any point in the study. Authority is recorded before activity rather than signed retrospectively, supporting attributable, contemporaneous evidence.

Yes. AQ Digital DoA connects delegated responsibilities to GCP, protocol and SOP training evidence, and aligns system permissions with delegated authority. This reduces the gap between what someone is authorised to do and what they can access, so delegation, qualification and access stay consistent across the study.

AQ Digital DoA gives consistent delegation visibility across studies, sites and teams, replacing local logs that vary site to site. As staff join, leave or change roles and protocols are amended, updates reflect across connected records. Multi-site networks and sponsors get one reliable view of authorisation across the whole programme.

Paper logs become outdated quickly, are signed late and disconnect from training, access and activity. AQ Digital DoA keeps delegation linked to live study activity, with approvals captured before work starts and a full role history for monitoring, sponsor review and inspection. Authorisation becomes evidence you can prove, not a document you reconstruct.