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Good Clinical Practice Summary

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The purpose of this manual is to provide the Principal Investigator, project managers, research and nurse coordinators or administrators, and all those associated with clinical research trials & studies, with an overview of the processes, committees and departments that they will work with throughout the submission, review, approval and conduct of the human subject study or clinical trial.
This manual will provide an overview on the scope of activities encompassed by Human Subject Research (HSR). HSR is very broad and includes scientific, investigatory and research activities involving human subjects, clinical data, or any materials (including tissues, serum, cells, and DNA) from any Human source, whether specimens are from a known, specified …show more content…

For researchers, complying with Good Clinical Practices (GCPs) often means creating, and adopting policies into every aspect of the investigational site’s research.
The purpose of these documents is to establish internal procedures for the identification and evaluation of consensus standards in research practice. These policies & SOPs describe the processes that are used by the research program. The policies that follow are intended to complement existing processes and procedures. These are generic and should be viewed as recommendations.

Naufar has a broad research governance framework which comprises a range of principles, policies, procedures and guidelines that regulate research at naufar Center. The Guidelines on Good Research Practice provide one element of this framework. The Guidelines are supported by detailed policies, procedures and guidelines including for investigating allegations of science misconduct, ethical review, health and safety, grant management, research management and confidentiality of data and records.

Research conducted at Naufar must be undertaken to the highest standards in accordance with good research practice. These Guidelines set out the framework for good research

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