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Academic Clinical Trials Program Guidelines & Instructions Effective dates: August 29, 2022, June 30, 2023Table of Contents Key Points...................................................................................................................................2
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Read and familiarize yourself with the new clinical trial rules and regulations
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Determine the specific requirements and documents needed for the trial
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Fill out the necessary forms and documentation accurately and completely
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Ensure all ethical guidelines and regulations are followed throughout the trial process
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Submit the completed documentation to the appropriate regulatory authorities for approval
Who needs new clinical trial rules?
01
Researchers conducting clinical trials
02
Institutions and organizations overseeing clinical research
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Regulatory authorities and government agencies
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What is new clinical trial rules?
The new clinical trial rules are regulations that govern how clinical trials should be conducted and reported.
Who is required to file new clinical trial rules?
Any organization or individual conducting a clinical trial is required to file the new clinical trial rules.
How to fill out new clinical trial rules?
The new clinical trial rules can be filled out online through the designated portal provided by the regulatory authority.
What is the purpose of new clinical trial rules?
The purpose of the new clinical trial rules is to ensure transparency, data integrity, and patient safety in clinical trials.
What information must be reported on new clinical trial rules?
The new clinical trial rules require reporting of study protocols, informed consent forms, adverse events, and final study results.
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