Keyword Analysis & Research: research and development sop

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What are the University Clinical Research SOPs?

Our University clinical research SOPs define processes in-line with the laws, policies and regulations governing human subject research and should be utilized by all personnel conducting such research at the University of Utah. My department already has SOPs on these topics but they have more details specific to my group.

What is the purpose of an SOP?

SOPs ensure that sites follow Federal Regulations, International Conference on Harmonization Good Clinical Practice Guidelines, and UH Institutional Policies to protect the rights and welfare of human study participants. Act as a training tool for new employees and/or trainees.

What is the SOP ‘designing and approval of artwork?

These artwork shall be approved as per the SOP ‘Designing and Approval of Artwork’ . R&D shall send samples of the new product manufactured at lab scale to the Head, Production with specifications for the required dies & punches, any additional change part &/or any additional instrument/machine (if required).

What should the principal investigator do with sops?

The Principal Investigator should approve all SOPs and designate an effective date. SOPs should be reviewed on a regular basis (usually annually) to ensure policy based regulations are up-to-date. Previous versions of SOPs should be retained. SOPs are an integral part of good research practice!

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