As a reminder, the WVCTSI Clinical Trial Center of Excellence (COE) has issued Standard Operating Procedures (SOP) that provide harmonized guidance to help define standard practices and ensure execution of human subject research is in accordance with institutional, state and federal regulations. Research personnel responsible for human subject research are encouraged to read and understand the SOPs.
COE SOPs are currently undergoing review with 10 SOPs effective on October 15, 2025.
Currently two sessions are planned to review the 10 SOPs. An information/training session has been planned on Wednesday, September 24 from 1:00 to 2:00 p.m. and Thursday, September 25 from 11:00 to 12:00 p.m. Please RSVP if you plan to attend via zoom. The session has an associated assessment and a certificate can be provided for completed assessments as needed.
Wednesday, Sept 24 from 1 to 2 p.m.
- COE-105.01 - Clinical Research Personnel Responsibilities and Training Program
- COE-101.01 - Mission, Goals and Governance
- COE-111.01 - External Safety Reports
- COE-110.01 - Informed Consent Process: Development and Implementation
- COE-113.01 - Data Management: Security, Confidentiality, Sharing, Transmission, and Archiving
Thursday, Sept 25 from 11 to 12 p.m.
- COE-120.01 - Electronic Signatures
- COE-117.01 - Sponsor/CRO Communication
- COE-118.01 - Institutional Review Board (IRB) Communication
- COE-119.01 - Clinical Research Assessment and Appeals Process
- COE-104.01 - Registration of Clinical Trials
All COE SOPs can be accessed here.
The SOP training sessions will posted on the WVCTSI YouTube by Monday, September 29 for any team members that were not able to attend the live sessions and wish to view them.
If you have questions, please do not hesitate to contact Shelley Welch, Director of the WVCTSI Clinical Trials Center of Excellence at shelley.welch@hsc.wvu.edu or 304-293-7348.