Regulatory Affairs

Office of the Vice President and Innovation

Category results for: Policies & Guidance

VCU Health Policy Update

As of July 25, 2018, VCU Health has updated the following policy:  Protected Health Information: Minimum Necessary Uses and Disclosures (MR.PH.006).  Click here to review this updated policy.

Newly approved VCU-VCUH clinical research SOPs

The following VCU-VCUH clinical research standard operating procedures have been published in support of clinical researchers across our program: CR-CO-500.1 Blinding – Codes and Code Breaking CR-CO-505.1 Case Report Form Compliance CR-CO-510.1 Clinical Research Record Management CR-CO-520.1 Data Management CR-CO-525.1 Delegation of Authority CR-CO-530.1 Electronic Data Capture CR-CO-540.1 Essential Documents Maintenance CR-CO-545.1 Participant Status and […]

Updated OnCore Use Requirements (Notice 16-001.3)

The VCU Research Compliance Notice 16-001.3, OnCore – Clinical Research Management System, has been updated.  Modifications to the document were made to  strengthen requirements for documenting participant enrollment and visit/procedure completion within the system. Please review the updated requirements using the link, above. Summary of OnCore Use Requirements: Study enrollment status must be updated within […]

Updated Compliance Notice (17-003.2) Registration and Results Reporting

Please review the recent update to VCU Compliance Notice 17-003.2 Registration and Results Reporting.  This compliance notice was updated to incorporate the expanded National Institutes of Health interpretation of ‘clinical trials’.

NEW RESOURCE: VCUHS Clinical Research Team – Clinical Permissions Table

A new resource for clinical research teams is now available: VCUHS Clinical Research Team – Clinical Permissions Table This table identifies those specific clinical skills which may be performed by VCU/VCUHS research nurses/coordinators who have patient contact within the health system. The table also identified requisite training/clinical competency criteria in order to perform those clinical […]

VCU-VCUH CRC/Research Team Monthly Meeting

VCU-VCUH CRC/Research Team Monthly Meeting Next Meeting Date:     March 13, 2018 Topic:     Clinical Permissions:  Planning for Competencies Location:     Sanger Hall, 1-044 Time:     11:00 am – 12 noon Please mark your calendars:  This meeting will be held the second Tuesday of each month.  Topics and location will be confirmed in advance of each scheduled meeting. *The […]

Updated Clinical Trial Decision Tree

An updated Clinical Trial Decision Tree is now available to assist researchers with identifying clinical trials in accordance with new NIH submission requirements as well as registration and reporting requirements, and publication recommendations related to clinical trials. NIH Submission of Clinical Trials:   It is essential that new clinical trial proposals and competitive renewals submitted […]

Upcoming SOP Review Deadline January 8, 2018

Upcoming VCU/VCUHS Standard Operating Procedure (SOP) Comment Due Date: January 8, 2017 — By this date, please submit any comments regarding the following draft SOPs to Study Interim Data Analyses and Reports Transfer of Participants Between Institutions Use of Notes to File Early Termination or Closure Study Completion During this time, we continue to carefully consider […]

New Research Compliance Notice 17-010.1 VCU Employee and Facility Use Guidelines for Clinical Research

A new VCU Research Compliance Notice 17-010.1 VCU Employee and Facility Use Guidelines for Clinical Research has been finalized.  The purpose of these published guidelines (including requirements and recommendations) is to support principal investigators, who must ensure that: VCU employees with direct interactions with research participants are prepared with adequate training and experience for their job responsibilities […]

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