Over the course of a long-term study, several small amendmen…
Over the course of a long-term study, several small amendments are made: additional questionnaires, extra lab draws, and slightly longer visit durations. Individually, these changes are minor. How the study team handle informed consent?
Read DetailsDuring a Phase II clinical trial, the sponsor proposes minor…
During a Phase II clinical trial, the sponsor proposes minor amendments to the protocol, such as additional blood draws and questionnaire assessments, which are considered low risk. The investigator wonders whether updated consent is necessary. Which statement best reflects the regulatory and ethical requirements regarding informed consent?
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