VCU Electronic Resources for Clinical and Translational Research Teams

The following clinical research systems are available for use in facilitating:

  1. Protocol Development and Cohort Discovery
  2. Recruitment
  3. Electronic Informed Consent
  4. Study Management
  5. Regulatory Management

(1) Protocol Development and Cohort Discovery

ACT

ACT was developed by members of the CTSA network to enable cohort discovery using a web interface in a HIPAA-compliant manner, without requiring study-specific IRB approval. It offers open access to a national network of leading academic medical research centers and generates aggregate patient count data from an investigator’s real-time, iterative searches.

Using ACT, researchers can explore patient populations, confirm and demonstrate study feasibility and identify potential partners for multi-site studies.

TriNetX

TriNetX allows VCU researchers to query the VCU Health electronic health record system (Cerner), IDX, OnCore, and Tumor Cancer Registry for a specific potential participant population in a de-identified manner for study feasibility and to help with study design.

Protocol Builder 

ProtocolBuilder is a secure, cloud-based technology which provides organization, guidance, and collaboration tools for writing your interventional or observational research protocols. ProtocolBuilder provides 11 unique protocol templates which set the outline and structure for your protocol. Collaboration with both internal and external colleagues and contributors is easy with the ability to add people as editors or reviewers, compare protocol versions, send requests for changes, and see revisions. You can import and share your reference library and ProtocolBuilder™ will automatically number your citations/references.

(2) Recruitment

Study Finder

 Study Finder helps identify VCU studies that need volunteers.

ResearchMatch

ResearchMatch is a free service to connect research studies with interested participants.

(3) Electronic Informed CONSENT

DocuSign 

A university-wide license and business associate agreement (BAA) for the DocuSign electronic signature service have been established. DocuSign is a cloud-based application that can be accessed from anywhere and anytime on most devices and provides an audit trail of signatures.

eConsent Application

VCU’s eConsent Application is a VCU-developed resource in REDCap facilitating the informed consent discussion as well as documenting informed consent.  This application is not CFR 21 Part 11 compliant, thus is not appropriate for FDA-regulated human research.  

COVID MyStudies Application (App) 

Through the COVID MyStudies app, the investigator can send the informed consent document electronically to the patient or his or her legally authorized representative. Once the patient or representative has signed the form, he or she will receive an electronic copy. The investigator can then access the signed consent in a secure manner and print it or transfer the file electronically. Methods for obtaining informed consent remotely were discussed in a recent FDA guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” 

(4) Study Management

OnCore 

OnCore is the enterprise-wide clinical research management system at VCU and VCU Health. The system collects study, participant, and procedure data to enhance clinical trial participant safety, provide accurate institutional metrics, improve research billing compliance, and increase sponsor-funded cost recovery. 

REDCap

REDCap is an on-line, server-based, secure web application used to build online surveys and databases. It collects any type of data and is geared to support data capture on a category one server.  Use your VCU eID to sign in.

(5) Regulatory Management

Cardone

Access to patient medical records for external monitors is available via printed paper copies filed in the participant’s research record or through Cardone, VCU Health’s document access solution. 

SiteVault Free for COVID-19 Trials

SiteVault Free is a cloud e-regulatory solution that provides remote clinical research applications for COVID-19 trials. It supports clinical research teams with compliance and access to study documents through an electronic regulatory binder with fully electronic signature workflows.  It also provides monitors with secure, direct access to these study binders. 

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