Stage 6 · Toolkit 6.5
Decentralised / Hybrid Trial Add-On
Manage decentralised trial elements, remote consent, telemedicine, wearables, home nursing, and digital data oversight.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Decentralised / Hybrid Trial Add-On.
How it helps your team
Apply the right controls to the phase-specific decisions that matter most.
Designed for
Clinical Development, Clinical Operations, pharmacology, bioanalysis, statistics, safety review, and programme teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- Decentralised Trial Operations Plan
- Remote Consent Procedure
- Telemedicine Visit Guide
- Wearable / Digital Data Oversight Plan
- Home Nursing Vendor Oversight Plan
- Decentralised Trial Risk Decision Memo
Excel workbooks
- Decentralised Trial Risk Register
- Remote Visit Tracker
- Digital Device Issue Log
- Home Nursing Vendor Oversight Tracker
- Digital Evidence Matrix
Related toolkits
Continue within stage 6
Phase I / First-in-Human Trial Management
Manage FIH operations, dose escalation, sentinel dosing, stopping rules, safety review, and cohort decisions.
6.2Phase I PK/PD & Bioanalysis Operations
Manage PK/PD sampling, bioanalysis handling, review, shipment, and evidence readiness.
6.3Phase II Proof-of-Concept & Dose-Finding
Govern dose-finding, interim analysis, efficacy endpoints, safety monitoring, and PoC decisions.