HRA Technical Assurance: Pharmacy and Radiation Reviews
HRA Technical Assurance settles the specialist pharmacy and radiation questions in a study once, before the application reaches a Research Ethics Committee. This guide covers what Pharmacy Assurance and Radiation Assurance each review, who performs the review, the published clocks, when each submission is due, and what a site receives.
What Is NCVR? National Contract Value Review Explained
NCVR is the UK’s standardised national process for agreeing what a commercial contract research study costs to deliver in the NHS. This guide covers the three mandated components of an NCVR price, the process step by step, the 30 day review clock, the removal of site escalations on 1 July 2026, what is in scope, and what a participating site still decides.
CPMS and LPMS: What Sites Must Enter and When
CPMS is the national record of every study on the NIHR RDN Portfolio, and an LPMS is the local system a site works in. This guide covers how the two exchange data, the three record levels and who owns each, the site milestone fields and what makes each one due, the NIHR definition of recruitment, the timing rules and why confirmation queries appear.
Capacity and Capability Confirmation: Timelines and Delays
Capacity and capability confirmation is the point at which a participating NHS organisation tells the sponsor it has the arrangements in place to deliver a study. This guide covers the definition, the three HRA stages, the 35-day period and where it starts, the two confirmation routes, where the time is actually lost, and how the four UK nations differ.
Date Site Confirmed: The January 2026 Site Set-Up Change
The Date Site Confirmed is the last contract signature across all organisations at a site. From January 2026 it ends the 60-day site set-up metric in UK clinical research delivery reporting. This guide covers the definition, what moved, why the two site metrics no longer sum to elapsed time, and the six dates a site must record.
Why NHS Sites Miss the 90-Day Set-Up Target and How to Close It
The 90-day set-up target gives an NHS site three months from regulatory approval to a first participant, and most sites miss it. This guide covers what the target measures, where the 90 days go stage by stage, why the same target produces 100% at one trust and 0% at another, and how to measure your own window.
What is a Clinical Research Delivery Centre (CRDC) and How Does Multi-Site Research Oversight Work?
A Clinical Research Delivery Centre (CRDC) creates a coordinated research network where multiple NHS sites deliver clinical trials under shared governance, oversight, and quality standards aligned with MHRA, ICH-GCP E6(R3), and UK Clinical Trials Regulations. This guide explains how CRDCs operate, why multi-site research oversight demands connected control across every participating site, and how AQ […]
Study Set-Up Challenges: An Operational Problem Taxonomy
Study set-up challenges fall into six operational classes, and each one hides the same failure: a dependency the study record does not hold. This guide sets out the six classes, the artefact that settles each, where published start-up data shows the time actually goes, and what a study record must hold before the first participant.
