| English term or phrase: query responses | The investigator agrees to keep the records stipulated in Section 12.1 and those documents that include (but are not limited to) the study-specific documents, the identification log of all participating subjects, medical records, source worksheets, all original signed and dated informed consent forms, subject authorization forms regarding the use of personal health information (if separate from the informed consent forms), copies of all eCRFs, query responses, and detailed records of drug disposition to enable evaluations or audits from regulatory authorities, the sponsor or its designees.
спасибо |
| MariaMMKudoZ activityQuestions: 360 ( 4 open) ( 13 closed without grading) Answers: 0
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