Critical SOPs for Clinical Sites
Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.
Description:
Recent FDA guidance documents suggest that clinical investigators develop standard procedures (SOPs) for key activities conducted at their site and assure that staff members (e.g., subinvestigators and clinical research coordinators) appropriately follow the same. Several industry organisations have similarly proposed multiple SOPs that are critical for maintaining quality procedures at clinical sites.
This webinar will highlight which SOPs should be implemented and what methods should be used to develop and document FDA-acceptable conduct of clinical sites activities. The author would address the competing opinions available from various sources about both topic selection and the depth of coverage or detail that is required. In this interactive session, the presenter would share his experience in site management and procedure development. Participants will leave the session with tools to help them assess what is appropriate for their practice setting and an action plan for addressing their site's specific needs.
Why should you attend:
If you are a hospital, clinic, individual physician, nurse, clinical trial professional or a sponsor of a clinical trial, this seminar will provide valuable suggestions about which SOPs should you develop, how should you train your staff, what kind of documents should you create to demonstrate your compliance with FDA regulations, and tips for troubleshooting common issues. Also discussed will be issues related to products being tested, responsibilities of individuals, resources available, and projected trends for the near future.
Objectives of the presentation:
At the end of this webinar, you would understand:
Current FDA expectation from clinical sites
List of key SOPs critical to demonstrate GCP compliance
Best practices related to SOP development and maintenance by clinical sites
Current industry practices for SOPs
Common issues with FDA audit for site processes.
Who can benefit:
Clinical Research Associates (CRAs)
Clinical Research Coordinators (CRCs)
Clinical research administrators
Data managers
Principal investigators
Project managers
Sponsors of INDs
People investing in FDA-regulated product development projects
Time: 10:00 - 11:00
Venue: online, San Francisco
Cost: 243
More info:
online training