Early Phase Cancer Trials Programme at UCL and UCLH


Roles In Clinical Trials

Clinical Trial Roles at Site

In an early phase cancer trials programme, a multi-disciplinary team is required to deliver high quality trials efficiently and safely. Here is a description of the roles within a trial team.


Chief Investigator (CI) - The Chief Investigator is the overall lead researcher for a research project. For clinical trials this will always be a medical professional.


Principal Investigators (PI) - A Principal Investigator is the individual responsible for the preparation, conduct, and administration of a research project at a particular research site. There is only one Principal Investigator per research site. In clinical trials this individual is always a medical professional.

At a site, the Principal Investigator can also be the Chief Investigator.


Sub-Investigator (Sub-I) - The Sub-Investigato or Co-Investigator (Co-I) is a medical professional who is is under the supervision of the Principal Investigator and is responsible for performing some study–related procedures and /or to make important study-related decisions, but they do not accept primary responsibility for the research study.

At sites the Sub-I is usually another consultant who is working on the trial or Clinical Research Fellows working under the supervision of the Consultant (and Principal Investigator).


Clinical Research Nurses (CRN) - Specialist nurses with research and clinical trial training. In addition to acting as a key role in conducting of a trial at site, they undertake additional clinical tasks related to their nursing experience as required in the clinical trials, such as taking patients vital signs, ECGs and providing the treatments.


Trial Coordinator (TC) - Responsible for setting-up of the study at a research/NHS site and acts as a point of contact between the research/NHS site and external sponsors.


Data Manager (DM) - Oversees the collection and management of the trial data and ensures it is accurate and secure. They are responsible for uploading and entering the clinical data onto trial databases for analysis and ensure all the trial documents and files are maintained.


Clinical Trial Practitioner (CTP) - CTPs work alongside the Research Nurses and Data Managers to ensure smooth facilitation of the clinical trial at a site.


Clinical Trial Pharmacist - A registered pharmacist who is a member of the research/NHS site and specifically trained in clinical trials responsible for the management of the investigation treatments and products. Their responsibilities extend to supply ordering, handling, storage, dispensing, accountability of the investigative treatment.


Trial Statistician - Work with investigators to develop trial ideas and are responsible for statistical aspects of trial design, data collection, analysis, and reporting results.


Trial Monitor - These are individuals usually external to the trial team at a research/NHS site who are responsible for monitoring the quality of the data and provide reports back to the sponsor and management of the trial who review the safety and conduct of a trial. They ensure trials are being run in a safe manner, data is being collected correctly and trials are in accordance with Good Clinical Practise (GCP).