“Data and Safety Monitoring Plan” attachment.Section 3.2: "Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?" - reflect updated instructions.“Section 2 – Study Population Characteristics” instructions now reflect updated exceptions for required questions.Significant changes were made for the following fields: Clarified and updated instructions throughout.Using the PHS Human Subjects and Clinical Trials Information form.Who should use the PHS Human Subjects and Clinical Trials Information form.Changes were made to the form’s organization in the following sections:. PHS Human Subjects and Clinical Trials Information form
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