Preparation for negotiation with sponsor

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Reference no: EM133840234

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The following documents should be collected and thoroughly reviewed in preparation for negotiation with a sponsor: U.S. Food and Drug Administration (FDA) regulations and International Council for Harmonisation (ICH) GCP guidelines CTA, budget, informed consent form The Form FDA 1572 (Statement of the Investigator) and IRB approval letter Confidential disclosure agreement (CDA).

Reference no: EM133840234

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