Study Team Roles Overview

A starting point of a RCT arises from a thoroughly explored and elaborated idea that will be then formulated by an adequate research question. Large-scale multicenter RCTs are often (in EEC this rate verges towards 100%) developed and funded by pharmaceutical companies, where, according to Pocock, S.J. (1983, p. 32), “the clinician treats his patients according to protocol and completes the data sheets but all other aspects of the trial… are run by the company”.


“Regardless of … the size of the trial, each member of the team must be educated in the conduct of clinical trials, the regulations that govern trials, and the protocol document that describes the trial to be conducted.” (Tompkins, A., 2007 in: Gallin, J.I. & Ognibene, p.67). From the first steps in the study there must be a well-defined chart of responsibilities. Usually the study team consists of the following members:


-PI – in charge of every aspect and the general outcome, fully engaged and involved from the feasibility stage and through the close-out activities, delegating some of his responsibilities to other team members, but performing a constant overview of their actions – e.g. every week team meetings to determine and resolve problems (unlike many bad examples from my practice of how PI must not perform their functions, being just a “face” of the Institution, Hospital or Department, though such behavior is prohibited by all applicable regulations (ICH GCP, 2016), there are cases when PI ‘exists’ mostly for signing the documents).


-Coordinator – (Actually, a CRA, is a Coordinator for investigational sites from a Sponsor’s side. It’s not heading the team, but making it successfully operating – beneficial for all colleagues). Thank to good coordinators all processes in the study are running smoothly from the moment of Investigator Meeting, through the data arrangement, collection and handover to the Sponsor. Coordinator may be also ‘in play’ for:


  • Lab samples collection, preparation and dispatch.
  • eCRF/CRF completion  and processing patients records  (data management)
  • Patients’ registration and randomization
  • Supplying treatments, checking compliance and study logs completion
  • Checking that protocol procedure is being adhered, etc.


- Sub-Investigator(SI) – in my study these would be Psychiatrists, Neurologists and Psychotherapists, who will be in charge of screening procedures, informed consent process (as it is usually delegated by the PI) medical history collection, and protocol treatment scheme administration, AE/SAE monitoring, source documents completion (inter alia). In any Psychiatric study Raters will be often required to perform scales rating at visits. This role is often combined with that of SI.


-Other technicians are often involved not as individuals, but as Departments (x-ray, ECG, local lab., etc.).

- Statistician, Data Management, publication and reporting is Sponsor’s responsibilities in this type of RCT.



ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6(R2) (2016).

Pocock, S.J. (1983) ‘Organization and planning’. In: Pocock, S.J. Clinical trials: a practical approach. Chichester: John Wiley & Sons, pp.28−41.

Tompkins, A. (2007) ‘Data management in clinical trials’. In: Gallin, J.I. & Ognibene, F.P. Principles and practice of clinical research. 2nd ed. Amsterdam: Elsevier, pp.67−69.

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