Standard Operating Procedures for Good Clinical Practice at the Investigative Site

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9780966359312: Standard Operating Procedures for Good Clinical Practice at the Investigative Site
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Standard Operating Procedures are critical to quality performance and the ethical conduct of clinical trials. Your SOPs are an indication of the level of professionalism at your investigative site.

Your SOPs reflect your site's philosophy, standards and innovations. That is why your SOP manual should be written specifically for how you conduct clinical research. When it comes to SOPs, one size doesn't fit all, it is custom work. Standard Operating Procedures for Good Clinical Practice at the Investigative Site can be customized to meet the needs of your site. Each of its 162 pages can be left as is, or altered to reflect the uniqueness of your research facility. Based upon the principles found in the ICH GCP Consolidated Guideline and the Code of Federal Regulations, it is written in an easy-to-read format that is clear, precise and pertinent to the day to day conduct of clinical research.

They template is provided in a 3-ring binder with two diskettes. Once the program is installed in your computer, it can be customized to fit your requirements. In addition the manual includes forms and checklists, sample job descriptions, evaluations forms, and a 184-page regulatory reference book.

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