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Infringements and Other Acts Amendment Act 2008 No. 9 of 2008table of provisions Section×Page Part 1Preliminary×1 1×Purposes×1 2×Commencement×2 3×Principal Act×2 Part 2Trial Expansion of Enforcement
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Who needs part 2trial expansion of?

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Part 2 trial expansion is needed by individuals or entities involved in conducting trials, research studies, or experiments.
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This form is typically required to document any changes or expansions in the trial protocol that were not previously approved.
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The trial expansion form helps to ensure that all parties involved are aware of and agree to the modifications being made.
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It may be required by regulatory bodies, funding agencies, or ethics committees to maintain transparency and adherence to protocols.
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Researchers, principal investigators, or organizations responsible for overseeing the trial may need to fill out this form.

What is Part 2Trial Expansion of Enforcement by Infringement Notice3 Form?

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Part 2trial expansion is the expansion of a clinical trial to include more participants.
The clinical trial sponsor is required to file part 2trial expansion.
Part 2trial expansion must be filled out with updated information on the trial protocol and participant recruitment.
The purpose of part 2trial expansion is to increase the sample size of the clinical trial for more accurate results.
Part 2trial expansion must report details on the new participants, revised protocol, and any changes to the trial design.
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