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AGRA Master Thesis Dr. Ulrich Cartel Clinical trial standard protocols, approaches for more regulatory efficiency? Wissenschaftliche Pr?fungsarbeit our Erlangen DES Titles ? Master of Drug Regulatory
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What is harmonisation of clinical trial?
Harmonisation of clinical trial refers to the process of aligning and standardizing the procedures and requirements for conducting clinical trials across different regions or countries. It aims to streamline the regulatory processes and facilitate the efficient and ethical conduct of clinical research.
Who is required to file harmonisation of clinical trial?
The responsibility of filing harmonisation of clinical trial generally falls on the sponsor or investigator conducting the clinical trial. It may vary depending on the specific regulations and requirements of each country or region.
How to fill out harmonisation of clinical trial?
Filling out the harmonisation of clinical trial typically involves providing detailed information about the study protocol, investigational product, study participants, informed consent process, adverse events reporting, and other relevant aspects of the trial. The exact procedure may vary depending on the specific guidelines and regulations of the country or region.
What is the purpose of harmonisation of clinical trial?
The purpose of harmonisation of clinical trial is to promote consistency and standardization in the conduct of clinical research across different regions or countries. It helps ensure the safety and welfare of study participants, facilitate data reliability and comparability, and simplify the regulatory processes for sponsors and investigators.
What information must be reported on harmonisation of clinical trial?
The information that must be reported on harmonisation of clinical trial generally includes details about the study protocol, investigational product, study participants, informed consent process, adverse events reporting, data management and monitoring, statistical analysis plan, and other relevant aspects of the trial. The specific requirements may vary depending on the regulations and guidelines of each country or region.
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