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Standard Operating Procedures (SOPs)

These are the current standard operating procedures (SOPs) that are being used within PRIMENT CTU. A SOP Working Group meet on a monthly basis to review the current versions while discussing the need for any new SOPs. 

Current Standard Operating Procedures:

PRM-SOP-001

SOP for SOPS

PRM-SOP-002

Risk Assessment

PRM-SOP-003

Document Version Control

PRM-SOP-004

Protocol Development

PRM-SOP-005

Site Initiation

PRM-SOP-006

Non-Compliance to Study Protocol, Regulatory Requirements and Serious Breaches of GCP or Trial Protocol

PRM-SOP-007

Statistics

PRM-SOP-008

Investigator Pharmacovigilance

PRM-SOP-009

Development Safety Update Report

PRM-SOP-010

CTU Pharmacovigilance

PRM-SOP-011

Essential Documentation and the Preparation and Maintenance of Trial Master Files

PRM-SOP-013

Urgent Safety Measures

PRM-SOP-014

Clinical Trial Monitoring

PRM-SOP-015

IMP Labelling

PRM-SOP-016

Randomisation, Blinding and Code Breaking

PRM-SOP-017

IMP Destruction, Return and Recall

PRM-SOP-018

Validating Sealed Envelope Systems

PRM-SOP-019

Data Handling

PRM-SOP-020

Change Control for Sealed Envelope Systems

PRM-SOP-021

Obtaining Informed Consent

PRM-SOP-022

Non-CTIMP Safety Management

PRM-SOP-023

MHRA, Ethics and HRA Approvals

PRM-SOP-024

Development, Review and Approval of Case Report Forms

PRM-SOP-025

Managing Personal Data

PRM-SOP-026

Database Lock, Unlock and Closure

PRM-SOP-027

Amendments

PRM-SOP-028

IMP Logistics

PRM-SOP-029

Study and Trial Closure

PRM-SOP-030

Site Closure

PRM-SOP-031

Archiving

PRM-SOP-032

Health Economics

PRM-SOP-033

IMP Forecasting & Tendering