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NPRA/422/01PUSAT PENILAIAN PRODUK & KOSMETIK BAHAGIAN REGULATORI FARMASI NEGARA (NPRA)Senarai Semak Untuk Permohonan Pendaftaran Produk Baru, Seksyen Ubat BaruNama Produk: ___ Nama & Alamat : ___
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How to fill out format for clinical studies

01
Obtain necessary protocol from research team or sponsor.
02
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Who needs format for clinical studies?

01
Researchers conducting clinical studies.
02
Sponsors funding clinical studies.
03
Regulatory bodies overseeing clinical studies.

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The format for clinical studies typically refers to a standardized presentation of the study design, methodology, results, and conclusions, often required by regulatory authorities.
Researchers, sponsors, and organizations conducting clinical studies are generally required to file the format for clinical studies.
To fill out the format for clinical studies, follow the guidelines set by regulatory bodies, ensuring to provide sections on study objectives, methods, results, and ethical considerations.
The purpose of the format for clinical studies is to ensure consistency, transparency, and clarity in reporting clinical research findings to facilitate understanding and regulatory review.
Key information must include study purpose, design, participant demographics, intervention details, outcomes measured, results, and conclusions drawn from the study.
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