Implementation and Utilization of Standard Operating Procedures (SOPs) at the Clinical Research Site

This webinar will assist clinical research personnel in developing/acquiring SOPs for their site. You will learn how to create a compliant but user-friendly set of SOPs that can pass regulatory audits and also be a useful tool for the site staff.

Why Should You Attend:

ICH GCP guidelines require that all research sites have “Detailed, written instructions to achieve uniformity of the performance of a specific function.” Regulatory agencies are now requiring that every site have a set of SOPs for the elements of clinical research to assure compliance with ICH GCP and ask to review the site’s SOPs during audits.

This course will cover the minimum requirements necessary for SOPs to pass a regulatory audit. It will also offer tips on streamlining the process of development and implementation of SOPs at the site level.

Learning Objectives:

You will learn why SOPs are required at the site level, how to develop SOPs and how to implement them.

Areas Covered in the Webinar:

The webinar will include the following critical information you will need:

• Background information for Site SOPs.
• Required SOPs to pass a regulatory audit.
• How to streamline the process of the development/acquisition of SOPs for the site.
• How to simplify your SOPs for ease of use.
• How to implement SOPs at your site.
• Assuring documentation of training on SOPs.
• Best practices and common errors in writing SOPs.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel/companies in the clinical research industry. The employees who will benefit most include:

• Principal Investigators
• Research Nurses
• Study Coordinators
• Site Regulatory Personnel
• Clinical Research Site Administrators
• Sponsor site selection personnel
• CRAs
• Quality Assurance
• Documentation professionals both at the site and sponsor companies