Authors: Carol Saunders, RN, Arna Shefrin, MS, Eileen Rusnak, CIP

Standard operating procedures (SOPs) 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 and reflect your site’s philosophy, standards and innovations. That is why your SOP manual should be written specifically for how you conduct clinical research. Standard Operating Procedures for Good Clinical Practice at the Investigative Site can be customized to meet the needs of your site.  Each of its 184 pages can either be left as is, or altered to reflect the uniqueness of your research facility. Based upon the principles found in 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.

This SOP template is provided in a 3-ringed binder with a CD-ROM containing an MS Word program for Windows users only. Once installed on your computer, it is easy to use and can be customized to reflect your company’s philosophy, standards and innovations.

Standard Operating Procedures for Good Clinical Practice at the Investigative Site will showcase your site’s blueprint for compliance, thus highlight your critical standards valued by sponsors, CROs, and, above all, your research team.

The SOP template includes:

• Forms and checklists
• Sample job descriptions
• Evaluation forms

Topics Include:

• General administration
• Study start up
• Project management
• Study management
• Data management
• Quality assurance
• Privacy practices