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Global Clinical Data PlatformMONKEYPOX CASE REPORT FORM (CRF)MODULE 4 INTRODUCTION The CRF is designed to collect data obtained through examination, interview and review of hospital or clinic notes
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A global clinical data platform is an integrated system designed to collect, manage, and analyze clinical trial data across various locations and timeframes, facilitating improved decision-making and regulatory compliance in drug development.
Sponsors of clinical trials, including pharmaceutical companies, biotechnology firms, and academic institutions conducting clinical research, are required to file information on the global clinical data platform.
To fill out the global clinical data platform, users must gather the required clinical trial data and follow the submission guidelines provided by the regulatory agency managing the platform. This typically involves completing specific data fields accurately and submitting the information electronically through the platform.
The purpose of the global clinical data platform is to centralize clinical trial data for enhanced visibility, improve patient safety, facilitate regulatory submissions, and streamline the approval process for new medical products.
Information that must be reported on the global clinical data platform includes details about the clinical trial design, participant demographics, study results, adverse events, and any changes made to the study protocol during its conduct.
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