Before a Study Can Begin

Before A Study Can Begin

For general inquiries about Before A Study Can Begin resources, please contact:

Starting a research study is like starting a business, the work begins long before you’re ready to open the doors to customers. Making sure that your protocol, statistical analysis plan, and data collection instruments are complete before you start recruiting will help you ensure that your data can be replicated. Complying with legal requirements (Institutional Review Board, Investigational New Drug application/Investigational Device Exception, ClinicalTrials.gov) protects you and VCU. The Wright Center can help you dot all the i’s and cross all the t’s.

Services	Tools and Facilities
Develop Your Protocol If you have questions about protocol development or need help getting started on your protocol, please contact the Wright Center’s research navigator listed in the contact box on this page. A biostatistician can help with study design and provide a statistical analysis plan Request a consultation with a study design expert Work with a community engagement expert to design an inclusive study The Protocol Review Oversight Committees can review unfunded studies (requires Institutional Review Board submission)	Develop Your Protocol National Institutes of Health (NIH) The NIH has a cloud-based protocol development tool, which has templates for Phase 2 or 3 clinical trials and behavioral/social science research involving human subjects. Researchers will need to create an account and profile. The templates are also available as word documents. NIH’s Institutional Review Board also has helpful protocol templates for IND, prospective data, secondary data and repository studies. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) SPIRIT provides a number of helpful resources, including a checklist and an e-protocol template system. A free trial is available; subscription is required for long-term use.
Legal and Policies If your study involves cancer (in any way) it must be reviewed by the VCU Massey Cancer Center Protocol Review and Monitoring Committee (PRMC) before submission to Institutional Review Board (IRB) submission If your study is a clinical trial, register it at ClinicalTrials.gov You may need to request a faculty-held Investigational New Drug application (IND) or Investigational Device Exemption (IDE)	Legal and Policies Submit your cancer related application to the VCU Massey Cancer Center Protocol Review and Monitoring Committee (PRMC) for review Submit your application to obtain approval from for your human subjects (Institutional Review Board) or animal care (Institutional Animal Care and Use Committee) research (link may require VCU login credentials) Register your trial at ClinicalTrials.gov Protocol Registration and Results System
Collecting and Managing Data An informatics specialist can help with data collection and management Request a consultation with a data collection and management expert Work with a community engagement expert to gain access to diverse populations Learn how the clinical trial management system OnCore can help you manage your study and collect your data	Collecting and Managing Data VCU’s Clinical Research Standard Operating Procedures are available to guide you in conducting your research (link may require VCU login credentials) The VCU Medical Center Clinical Research Unit provides physical space and support for conducting clinical research Request VCU Health System clinical, nursing and ancillary services The Wright Center’s Collaborative Advanced Research Imaging (CARI) facility provides access to a research-dedicated MRI scanner and other imaging research support Use the clinical trial management system OnCore to manage your study and collect your data (link requires login credentials and access to VCU VPN) Use a HIPAA compliant online data capture REDCap for data collection (link requires VPN login if off campus)
Get Unstuck Come to the Wright Center Consulting Hours for one-on-one help – contact the research navigator for details	Recruiting Participants Create a record for your study at ResearchMatch

Services

Tools and Facilities

Develop Your Protocol

If you have questions about protocol development or need help getting started on your protocol, please contact the Wright Center’s research navigator listed in the contact box on this page.

A biostatistician can help with study design and provide a statistical analysis plan

Request a consultation with a study design expert

Work with a community engagement expert to design an inclusive study

The Protocol Review Oversight Committees can review unfunded studies (requires Institutional Review Board submission)

Develop Your Protocol

National Institutes of Health (NIH)

The NIH has a cloud-based protocol development tool, which has templates for Phase 2 or 3 clinical trials and behavioral/social science research involving human subjects. Researchers will need to create an account and profile. The templates are also available as word documents. NIH’s Institutional Review Board also has helpful protocol templates for IND, prospective data, secondary data and repository studies.

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)

SPIRIT provides a number of helpful resources, including a checklist and an e-protocol template system. A free trial is available; subscription is required for long-term use.

Legal and Policies

If your study involves cancer (in any way) it must be reviewed by the VCU Massey Cancer Center Protocol Review and Monitoring Committee (PRMC) before submission to Institutional Review Board (IRB) submission

If your study is a clinical trial, register it at ClinicalTrials.gov

You may need to request a faculty-held Investigational New Drug application (IND) or Investigational Device Exemption (IDE)

Legal and Policies

Submit your cancer related application to the VCU Massey Cancer Center Protocol Review and Monitoring Committee (PRMC) for review

Submit your application to obtain approval from for your human subjects (Institutional Review Board) or animal care (Institutional Animal Care and Use Committee) research (link may require VCU login credentials)

Collecting and Managing Data

An informatics specialist can help with data collection and management

Request a consultation with a data collection and management expert

Work with a community engagement expert to gain access to diverse populations

Learn how the clinical trial management system OnCore can help you manage your study and collect your data

Collecting and Managing Data

VCU’s Clinical Research Standard Operating Procedures are available to guide you in conducting your research (link may require VCU login credentials)

The VCU Medical Center Clinical Research Unit provides physical space and support for conducting clinical research

Request VCU Health System clinical, nursing and ancillary services

The Wright Center’s Collaborative Advanced Research Imaging (CARI) facility provides access to a research-dedicated MRI scanner and other imaging research support

Use the clinical trial management system OnCore to manage your study and collect your data (link requires login credentials and access to VCU VPN)

Use a HIPAA compliant online data capture REDCap for data collection (link requires VPN login if off campus)

Get Unstuck

Come to the Wright Center Consulting Hours for one-on-one help – contact the research navigator for details

Recruiting Participants

Create a record for your study at ResearchMatch

C. KENNETH AND DIANNE WRIGHT CENTER
FOR CLINICAL AND TRANSLATIONAL RESEARCH

Office of Research and Innovation