San Francisco Bay Area

Welcome to the SOCRA San Francisco Bay Area Chapter page. Information for the latest meeting is below. If you have any questions, please reach out to the Chapter Chairperson or the SOCRA office at office@socra.org.

The SF Bay Area Chapter presents

Date:  March 21^st 2025

Time:  11.00 AM PST

Location:  Virtual

Title / Topic:

Mastering Adverse Event Reporting in Clinical Research: Best Practices, Regulations, and Challenges

Speaker:

Asma Khan, MS, MBBS, CCRC, CCRP

PRMS Manager

Stanford Cancer Institute

Asma is a Protocol Review and Monitoring System (PRMS) Manager at Stanford Cancer Institute for the past 7 years. In this role, she oversees the operations of the Data and Safety Monitoring Committee, the Scientific Review Committee, as well as monitoring and educational initiatives, ensuring the highest standards in clinical research quality and safety. She has over 15 years of experience in clinical research, Asma holds a medical degree from Pakistan and a Master’s in Clinical Research Management. She is also certified by the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA).

Objective(s):

• Provide a comprehensive understanding of Adverse Event (AE) reporting in clinical research
• Define and recognize the importance of AEs, identify different types of AEs, and understand the key steps involved in reporting them
• Discuss essential regulations, such as GCP, FDA, and ICH guidelines
• Explore the roles of investigators, sponsors, and regulatory bodies in the AE reporting process
• Examine common challenges faced in AE reporting and strategies to overcome them, along with post-marketing surveillance practices.

Through interactive polls and discussion, the session aims to engage participants, enhance their knowledge, and equip them with the tools needed to manage AEs effectively in clinical trials.

Continuing Education (CE): SOCRA members may claim 1.0 CE credit per hour of education. SOCRA members will receive Certificates of Attendance at the completion of the event.

RSVP: NOTE: Remote site agreements are NOT required for this chapter meeting.

Details to enable virtual attendance will be sent to all attendees who have RSVP'd.

COST:   FREE admission

Please register at   https://smccd.zoom.us/meeting/register/37khp8z3QB6XN6UZmHeICQ

On registering, you will receive a confirmation email containing information about joining the meeting.

Questions - Please contact: socrabayareachapter@gmail.com

All SOCRA members and non-SOCRA members are welcomed

Please share this announcement with your colleagues.