regulatory approvals

What Are Regulatory Documents In Clinical Trials?

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What Are Regulatory Documents In Clinical Trials? Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Fund to Shareholders. What is regulatory in clinical trials? For the purposes of clinical trials, regulatory approvals include any approvals by government or health

What Constitutes A Substantial Protocol Amendment?

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What Constitutes A Substantial Protocol Amendment? Amendments to the trial are regarded as “substantial” where they are likely to have a significant impact on: the safety or physical or mental integrity of the subjects, or the scientific value of the trial, or the conduct or management of the trial, or the quality or safety of