1.5 Who conducts research ?
Basically everyone can conduct research who has a particular interest to investigate a certain question in further detail; This can be laymen, carers, teachers, health care professionals, doctors and students, but the biggest stake in health care research have probably academic organisations and pharmaceutical companies.
- Principle Investigator (PI): Has primary responsibility for achieving the success of the project, has ultimate responsibility for the management of the research, usually develops research questions and protocol, carries out the project's financial plan reports project progress to the sponsor, complies with all relevant policies and regulatory authorities, has responsibilities and prerogatives in the selection, training, and evaluation of project staff,
- Study co-ordinator/core study team: Assists with study design and protocol development, prepares study materials (such as patient information leaflet, questionnaire, poster), conducts reports for the PI and the sponsor, helps get approval to conduct the study, coordinates day-to-day study operations, interacts with study participants, schedules appointments, collects data (questionnaires, interviews, samples), develops study logistics (payments, mail outs, stationary)
- Study nurse: plans, conducts, evaluates study activities with patients in a hospital setting or in a private practice, handles the direct patient communication, administrative matters. The role can be limited to the duration of a study and the profession can be carried out on a free-lance basis, or it can be full time and centre linked.
- Study/Data Administration: Prepares and maintains documents, organises meetings, sends out information on behalf of the researchers, gathers information, processes requests, oversees all aspects of study data, protects especially patient health information data, keep track of all other research related records, makes sure that all data will be handled in line with data protection regulations.
- Sponsor : is the organisation/s taking overall responsibility for the trial. The sponsor is responsible for implementing and maintaining, quality assurance and quality control systems and the production of written standard operating procedures to ensure that trials are conducted and are data generated, recorded and reported in compliance with the protocol, GCP and MHRA requirements. In academic led studies these duties are often delegated to the Chief Investigator who is responsible for the study.