Summary

The Clinical Investigator Collaborative (CIC) Standard Operating Procedures (SOP), developed by a group of investigators at McMaster University, are a compilation of processes and procedures regarding the conduct of clinical trials and are an indication of the level of professionalism at each CIC investigative site.

The CIC-SOP’s include detailed descriptions of the site’s processes and procedures to meet the requirements of the regulations and guidelines. CICSOP’s provide a blueprint for compliance, highlighting CIC critical standards that are valued by sponsors, contract research organizations and the entire research team.

The CIC Standard Operating Procedures are based upon the principles found in the Good Clinical Practise Consolidated Guideline and the Code of Federal Regulations. Each document is clear, precise and pertinent to the day-to-day conduct of clinical research at the investigative site research facility.

Utilizing the CIC Standard Operating Procedures at the investigative site will ensure the quality required for a successful outcome. By using the CIC-SOPs, which support Health Canada and FDA regulations, they provide study sponsors with quality assurance, expedite the drug approval process and promote patient safety.