One VCU Clinical Research

Posted on July 27, 2017 by lballanc

The following new Clinical Research SOPs (5) have been approved and posted on the VCU/VCUHS Clinical Research Standard Operating Procedures Page:

Section 1 – Administrative:

• CR-AD-100.1 Maintenance of VCU/VCUHS Clinical Research SOPs

• CR-AD-105.1 Investigator Responsibilities

• CR-AD-110.1 Participating Investigator Qualification

• CR-AD-115.1 Study Feasibility

• CR-AD-120.1 Clinical Research Management System

The next round of reviews are due August 3, 2017 for the following draft SOPs:

Section 2 – Study Start-Up:

• Cost Coverage Analysis (deadline extended)

• Pre-site Visit

• Research Staff Training & Essential Documents

• Site Initiation Visit

• Study-Specific Staff Education & Training

Section 3 – Regulatory:

• Adverse Event and Serious Adverse Event Reporting

In the meantime, we continue to carefully consider all comments submitted for the last round of SOPs and begin finalizing SOPs for publication.

For additional project information or to make suggestions regarding any SOP, contact the project team at CRSOP@vcu.edu or contact Mary Harmon (VCU Health), Lisa Ballance (VCU Office of the Vice President for Research) or any of our school/center review group leaders: Catherine Brown (Massey Cancer Center), Rashmi Pershad (School of Medicine), and Lydia Klinger (Wright Center).