Jun
5
Mon
SCCR Virtual GCP Workshop: Electronic Documents and Electronic Data in Clinical Research @ Zoom Meeting Link
Jun 5 @ 9:00 am – 10:30 am
SCCR Virtual GCP Workshop: Electronic Documents and Electronic Data in Clinical Research @ Zoom Meeting Link


Speaker: Leonard Basobas, MS

Click HERE to Register!

Zoom Class Link

The mission of the Stanford Center for Clinical Research (SCCR) includes offering educational resources, training, and support for investigators and research staff.  We have invited the Clinical Research Director of Emergency Medicine, Leonard Basobas, MS, to present you with overview of the Good Clinical Practices (GCP) around Electronic Documents, Records, and Electronic Data Entry in Clinical Research, along with practical examples for content application.

At the conclusion of this class, you will be able to: 

  • Describe the electronic documents and data
  • Understand relevant regulations and guidance for data quality assurance
    • Overview of ICH GCP E6 R2
    • Good Documentation Practices (GDP)
  • Identify electronic data entry and data capture
  • Recognize sources of data and source data verification
  • Learn Best Practices

Attendance is open to all research staff.

About the Instructor:
Leonard Basobas, MS, is currently the Director of Growth & Development for the Emergency Medicine-Clinical Research Unit (EM-CRU) at Stanford University. He has over 20 years of experience in the field of Clinical Research, he was a Sr. Research Manager at Stanford Center for Clinical Research (SCCR), and a Study Lead, Sr. Project Manager at various academic institutions, Contract Research Organizations (CROs), large health care systems, and in the private sector. Leonard has extensive experience successfully building and managing cross-functional teams, and training and developing staff in accordance with Good Clinical Practice and federal regulations.

BRN OPTIONAL 

Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 1.5 contact hour(s).
To receive your certificate with BRN credit, you are required to complete an evaluation at the conclusion of this class.
BRN Cancellation Policy: If you wish to cancel your registration, please contact the course coordinators, Susan Saba, ssaba@stanford.edu.

Sep
15
Fri
SCCR Virtual GCP Workshop: e-Protocol Submissions for New Studies – A Practical Guide to Submitting Applications and Obtaining IRB Approval @ Zoom Meeting Link
Sep 15 @ 9:00 am – 10:30 am
SCCR Virtual GCP Workshop: e-Protocol Submissions for New Studies – A Practical Guide to Submitting Applications and Obtaining IRB Approval @ Zoom Meeting Link


Speaker: Janet  Cunningham, PhD

Click HERE to Register!

Zoom Class Link

The mission of the Stanford Center for Clinical Research (SCCR) includes offering educational resources, training, and support for investigators and research staff.  We have invited the SCCR’s Senior Regulatory Specialist, Janet Cunningham, PhD, to present you with an in-depth look at how to pursue IRB approval for the various types of clinical research studies being initiated at Stanford.  We will discuss important decision points that ensure studies are set up correctly for regulatory review, go over specific sections in the e-Protocol application that can be challenging to navigate, review development of consent forms, and present common obstacles that have been known to delay the approval process..

At the conclusion of this class, you will be able to:

  • Understand how to start and complete Stanford IRB e-Protocol applications
  • Have an overview of e-Protocol requirements related to STARR, HIPAA Waivers, Reliance letters, and Scientific and Scholarly Reviews
  • Understand how to work with central IRBs
  • Know how to write consent forms using Stanford Required Consent Language

Attendance is open to all research staff.

About the Instructor:
Janet Cunningham, PhD, is a regulatory specialist with 5 years of experience in clinical research projects at SCCR. She provides support and oversight for over 70 active clinical research studies in the GI-Hepatology division. This support includes preparation and submission of initial protocol applications and ICFs for both Stanford and central IRB review as well as submission of modifications, amendments, and reports. She also has experience managing IND applications and working with the FDA. Before crossing over to the field of clinical research, Janet served as a research scientist and Associate Director of Neurobiology for a Bay Area gene therapy company working on hemophilia, Parkinson’s disease, and a variety of other disorders.

BRN OPTIONAL
Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 1.5 contact hour(s).
If you wish to receive credit for attending this course, a $35 administrative fee will be charged to your STAP.
To receive your certificate with BRN credit, you are required to attend the live session, and complete an evaluation at the conclusion of this class.
BRN Cancellation Policy: If you wish to cancel your registration, please contact Susan Saba at <ssaba@stanford.edu> prior to the start of the class.