Information for Investigators

Once funding is confirmed, we will work closely with you to finalise the protocol and prepare submission documents for ethics review and, where required, MHRA approval. All documents will be developed promptly, in line with the agreed budget, relevant legislation, and good clinical practice standards. We will carry out a risk assessment to support smooth, compliant trial delivery.

At the same time, we will set up study sites for recruitment, establish supply arrangements, and implement data management and safety reporting systems. We will also ensure that essential Trial Master File documentation is in place. Where needed, we will coordinate with other University teams, including contracts and the sponsor office, to keep processes on track.

A strong partnership between the Chief Investigator and the trial management team is vital. Clear, regular communication allows us to address issues quickly and respond to new opportunities as the trial progresses.

Throughout the study, you will receive regular reports on recruitment, data quality, and other key metrics to provide assurance of safe and compliant trial delivery.

After the last patient has completed per protocol follow-up we will work with you to ensure:

• All data cleaning is complete and the final data set is locked for analysis
• Closure of all participating NHS study sites
• Close of out any third-party suppliers
• Final reports submitted as appropriate to the study e.g. REC, MHRA, funders, stakeholders, participants, and to trial registries where appropriate.
• Ensure that the Trial Master File is locked and archived as required by the sponsor and applicable regulations.

Every trial is different. We work with investigators to understand what each trial will require, this enables us to work up realistic costing. These inform the level of funding which needs to be in place to run an effective trial. 

Factors influencing cost  are:

• Type of study – CTIMP, non CTIMP, device trial
• Duration of each stage of the trial – set-up, recruiting, patient treatment, patient follow-up, data analysis and reporting.
• Number of patients/participants
• Number of study sites and types (e.g. PICs and treatment centres, hub and spoke models, locations and countries)
• Number of products to be sourced and/or coordinated (e.g. study drugs/IMPs, contrast agents, blood or biopsy sample packs)
• Screening and eligibility requirements e.g. simple one stage entry vs two stage recruitment where initial screening tests are required to confirm eligibility for a main study.
• Complexity of the design (e.g. single cohort receiving the same intervention vs multi arm multi stage dose escalation then expansion)
• Phase of trial (e.g. a First In Human study with a new product vs a phase 2 using a well-established and well-documented IMP).
• Number of biological samples per patient to be collected, shipped and tracked
• Volume and frequency of data to be collected per patient, schedule for data cleaning and reporting (e.g. single final report vs frequent dose escalation decisions or requiring interim analyses)
• Number of data sources and types (e.g. CRF data, laboratory, imaging, routine NHS data)
• Number of third parties to be managed: e.g. laboratories, IMP suppliers (manufacturer/packaging/labelling/QP/distribution)
• Stakeholder and reporting requirements
• Data management and monitoring requirements (based on risk assessment)
• Relationship with IMP providers – what reporting do they need and when (e.g. SAEs, SUSARs, DSURs)
• What interim reporting or analyses may be required by the design, funders or stakeholders.
• Source(s) of funding (with pricing as per Oxford University policies)

Trial Sample Management - Translational Support Unit

The Translational Support Unit (TSU) is a GLCP accredited dedicated laboratory based within OCTO and specialising in clinical trial sample management. The lab undertakes end-to-end sample tracking and oversight and is a central point for sample coordination. TSU staff engage with protocol and lab manual development early on in the life of a trial.

TSU hold the LEAF Gold award for sustainable laboratory practices.

Trial Sample Analysis

For laboratory-based analyses for a trial we will work with a Chief Investigator to identify appropriate third parties including laboratories.  Where required we will ensure that the laboratory is appropriately resourced and structured for the required purposes, and will oversee performance throughout the study, ensuring relevant information is collected and recorded within the Trial Master File.

OCTO will work with a Chief Investigator to identify appropriate third parties or provide services for the manufacture and supply of products required within the protocol. Where required we will ensure that selected parties are appropriate and able to fulfil the responsibilities delegated to them by the sponsor. 

During the trial OCTO will monitor the activities of the third party, ensuring relevant information and documentation is recorded within the trial master file.