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

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:

1. Background information for Site SOPs.
2. Required SOPs to pass a regulatory audit.
3. How to streamline the process of the development/acquisition of SOPs for the site.
4. How to simplify your SOPs for ease of use.
5. How to implement SOPs at your site.
6. Assuring documentation of training on SOPs.
7. 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

Instructor Profile:

Christine Hegi, RN, CCRP is the Founder and President of Hegi Research Corp. headquartered in Calgary, AB, Canada, which is a group of Independent CRAs offering clinical research consulting, auditing, site management and monitoring services to the pharmaceutical industry. Ms. Hegi has clinical research experience as the Global Project Manager for several large, multinational studies and has over 20 years of extensive experience in all phases of drug and device development.

Christine is the author of SOPs for Clinical Research Sites© which is a comprehensive set of Standard Operating Procedures available for purchase. These SOPs are unique in that they are designed to be customized by the site and to be utilized as a training tool for site staff.

Ms Hegi has authored and instructed CRA training courses for some of the major pharmaceutical companies as well as small organizations. She has taught multiple courses in SOP development and utilization. Multiple academic organizations have contracted her services for the presentation of ICH GCP and other research related courses. She has presented multiple times at professional conferences. Her previous experience as an Emergency Nurse, Study Coordinator, CRA and Director of Clinical Affairs bring both site and industry perspectives to her teaching.

Topic Background:

Most clinical research sites, from the small office set-up to large academic institutions, are overwhelmed at the thought of developing a quality set of SOPs for research at their facility. Frequently there is not staff at the site that has the knowledge or experience to write SOPs. It is estimated that it takes approximately 1,000 hours to write a comprehensive set of SOPs and this can be even longer if the documents must be completed by the committee process.

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