ClinicalStudyReport-GlobalHealthTrials.doc

Clinical Study Report [Study Title] [Study number] [Dd month yyyy] CONFIDENTIAL Signature pages for clinical study report I have read this report and confirm that to the best of my knowledge it accurately describes the conduct and results of the study. Signed: Date: ____/____/______ Print name: Affiliation: Address: Signed: Date: ____/____/______ Print name: Affiliation: Address: Signed: Date: ____/____/______ Print name: Affiliation: Address: Signed: Date: ____/____/______ Print name: Affiliation: Address: Signed: Date: ____/____/______ Print name: Affiliation: Address: TITLE PAGE Study title: Name of Test Drug: Indication studied: Study description: Sponsors: Protocol: Clinical Phase: Study dates: Investigators: Medical Officer: Sponsor signatory: GCP Statement: This study was performed in compliance with ICH Good Clinical Practise (GCP) including the archiving of essential documents Date of report: SYNOPSIS NAME OF SPONSOR NAME OF FINISHED PRODUCT N/A NAME OF ACTIVE INGREDIENT(S) INDIVIDUAL STUDY TABLE REFERRING TO MODULE 5 OF THE CTD Volume: Page: (FOR NATIONAL AUTHORITY USE ONLY) Title of Study Investigator(s) Study centre(s) Publication N/A Study period From: To: Phase of development Phase Objectives Primary Objective Secondary Objective Methodology Number of patients Planned: Analysed: Diagnosis and main criteria for inclusion Test product, dose and mode of administration Duration of treatment Criteria for evaluation Primary: Secondary: Statistical methods  NAME OF COMPANY NAME OF FINISHED PRODUCT N/A NAME OF ACTIVE I