Authors: Anna J. DeMarinis, M.A., MT (ASCP) SBB, CQA (ASQ), Carol Saunders, RN, BSN, Herbert Swarz, M.D.

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 by Sponsors ensures compliance with FDA regulations and ICH guidelines.

The SOP template includes:

• 30 SOPs addressing all GCP requirements
• Specific reference to the regulation or guidance addressed by the SOP
• 80 detailed procedures
• Forms, checklists, templates to integrate and document compliance

Topics include:

• Document Control
• Regulatory submissions and reporting
• Investigator selection and qualification
• Monitoring clinical trials
• Ensuring investigator compliance
• Human subject protection (IRB, consent)
• Data handling (CRF completion, electronic systems)
• Quality assurance (site audits, FDA inspections)
• Data Monitoring Committee determination