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CLINICAL TRIALS ACT 8 of 2011 1 September 2011 (unless otherwise indicated) ARRANGEMENT OF SECTIONS PART I PRELIMINARY 1. 2.3. 4. 5. 6. Short title Interpretation PART II CLINICAL RESEARCH REGULATORY

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What is clinical trials act?

The clinical trials act is a legislation that regulates the conduct of clinical trials for new drugs or medical devices.

Who is required to file clinical trials act?

Any organization or individual conducting clinical trials for new drugs or medical devices is required to file the clinical trials act.

How to fill out clinical trials act?

To fill out the clinical trials act, organizations or individuals must provide detailed information about the trial, including the study protocol, informed consent process, and safety monitoring procedures.

What is the purpose of clinical trials act?

The purpose of the clinical trials act is to ensure the safety of participants in clinical trials and the accuracy of the data collected during the trials.

What information must be reported on clinical trials act?

Information that must be reported on the clinical trials act includes the study protocol, informed consent forms, adverse event reports, and results of the trial.

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