911±¬ÁÏÍø

XClose

Early Phase Cancer Trials Programme at 911±¬ÁÏÍø and UCLH

Home
Menu

Roles In Clinical Trials

Clinical TrialÌýRoles 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.

Ìý

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

Ìý

Principal Investigators (PI) -ÌýA Principal InvestigatorÌýis 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.

Ìý

Sub-Investigator (Sub-I) -ÌýThe Sub-Investigato or Co-Investigator (Co-I) is a medical professional who is is under the supervision of the PrincipalÌýInvestigator and is responsible for performing some study–related procedures and /or to make important study-related decisions,Ìýbut 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).

Ìý

Clinical Research Nurses (CRN) -ÌýSpecialist 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.

Ìý

Trial Coordinator (TC) -ÌýResponsible 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.

Ìý

Data Manager (DM) -ÌýOversees 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.

Ìý

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

Ìý

Clinical Trial Pharmacist -ÌýA registered pharmacist who is aÌýmember of the research/NHS site and specifically trained in clinical trials responsible for the management of the investigation treatments and products. Their responsibilitiesÌýextend toÌýsupply ordering, handling, storage, dispensing, accountability of the investigative treatment.

Ìý

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

Ìý

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