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Subinvestigator
A subinvestigator is any member of the clinical trial team that has been so designated by the trial's investigator. This individual is under the direct supervision of the main investigator. Performance of procedures related to the critical trial, as well as the authority to make important trial-related decisions, are tasks of a subinvestigator at the study site. In essence, the investigator and subinvestigator have a collaborative agreement regarding the conduct of the trial. This agreement is the result of their discussions on the manner in which the trial will be conducted so that good clinical practices are strictly adhered to. These discussions occur before the first patient is screened, whenever questions arise, and continue throughout the trial.
In certain institutions the role of subinvestigator is assigned to individuals who meet certain criteria. For example, nurse practitioners can be designated as subinvestigators. Their advanced practice privileges allow them to perform physical examinations, diagnose disease states, and write prescriptions.
Further Reading
, & (1998)Design and analysis of clinical trials: Concepts and methodologies. New York: Wiley.
Glossary: Clinical research terminology. (2001, December). Applied Clinical Trials, 36–48.
, , & (1998)Good clinical practice (pp. 2–3). Chichester, UK: Wiley.
Systematic development of nursing interventions. Journal of Nursing Scholarship34(2)115–120(2002, Second Quarter)http://dx.doi.org/10.1111/j.1547-5069.2002.00115.x
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