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CIOMS, International Ethical Guidelines, Guideline 11) 30 | H A N DBO O K FO R GO O D CL INICA L RESE A RCH PR ACT ICE What can be done to minimize bias in a clinical investigation? Bias implies subjective or unfair distortion of judgment in favour of or against a person or thing. The purpose of conducting a clinical trial of an investigational product is to distinguish the effect of the investigational product from other factors, such as spontaneous changes in the course of the disease, placebo effects, or biased/subjective observation.

CIOMS, International Ethical Guidelines, Commentary on Guideline 2) “Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society). ” (Declaration of Helsinki) Application Principle 4 is applied through appropriate study design and through ethical, scientific, and, where applicable, regulatory review of the study protocol prior to study initiation. Questions and Answers Who is responsible for determining that the risk/benefit profile of a study is acceptable or unacceptable?

What is a “protocol amendment”? 45) What types of changes may require formal amendment of the protocol? Regional,1 national, or local laws and regulations may require sponsors to prepare formal protocol amendments to describe any change that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study. Examples of changes that generally require formal amendment include, but are not limited to: • changes in drug dosage or duration of exposure of individual subjects to an investigational product beyond that described in the current protocol; • significant increase in the number of subjects under study or in the duration of the study; • significant change in the study design, such as adding or dropping a study arm; and • addition of a new test or procedure that is intended to improve monitoring for or reduce the risk of a side effect or adverse event, or the dropping of a test intended to monitor safety.

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