Web1 CSR 40-1.030 Definitions (Rescinded April 30, 2024) ... statutory or regulatory definitions. (3) When the procurement is estimated to be ... (RFQ), telephone quotes, etc. (A) The … WebIt is appropriate to create new headings in the CSR and new Appendices for these topics. The guideline provides for and focuses on Efficacy and Safety variables known at the time. Other topics should be well referenced in the CSR body and clearly identified in the Table of Contents. Current submission options include: 1) Stand alone reports.

Clinical Study Report, Report Level Publishing, CSR Reports

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Aggregate Reporting and Regulatory Requirements

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