Sponsors and Regulatory Agencies are requiring that clinical research sites demonstrate that they have policies and procedures in place that ensure the site is in compliance with ICH GCP guidelines, Canadian TPD regulations, and USA FDA regulations.

 

Why does my site need SOPs?

Having a prepared comprehensive set of Standard Operating Procedures will demonstrate the site’s intention of compliance in the event of an audit. In addition, having SOPs indicates the site’s professionalism, valued by Sponsors and CROs in considering your site for the placement of clinical trials.

SOPs provide a process flow for the daily activities of clinical trials and ensure the quality and consistency of conduct. By defining individual responsibilities, SOPs increase the comfort level of staff and reduce the number of problems and queries.

The SOPs developed by HRC are unique in that they are designed as a training manual and encourage staff to reference applicable regulations and guidelines to expand their knowledge. The accompanying study tools, such as logs, checklists, calculators, and meeting agendas enhance the organisational skills and efficiency at the site level.


 
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