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Getting Started

CITI Program > WVU+kc > Create

STEP 1 - Complete The Required Training

  • CITI Program ethics training is required for all personnel listed on research projects. Scroll down for more information.  View the Training page for more information.

  • NIH Good Clinical Practice training is required for NIH funded research projects. Scroll down for more information.  View the  Training page for more information.

  • CITI Program Responsible Conduct of Research (RCR) training is required for federally funded research projects and most sponsored research projects.   View the  Training page for more information.
  • WVU+kc System Training - View this video for basic information on h ow to enter a protocol  application.
  • Students:  Refer to the Student Quick Start Guide

STEP 2 - Pre-Submission Requirements

Review the items below to determine if your project requires further approvals prior to submission.

Students:  Refer to the Student Quick Start Guide

Conflict of Interest in Research Disclosure

Complete the Conflict of Interest in Research Disclosure by selecting the "COI" tab in WVU+kc and following the prompts to either "Create" or "Update" the annual requirement for Principle and Co-Investigators) 

Key Personnel (Principle and Co-Investigators) listed on a submission must complete the  Conflict of Interes t in Research Disclosure.  The disclosure must be completed before a protocol application can be submitted for review and approval. Refer to the WVU Research COI website for more information.

 Research Classification\Protocol Submission Category

1. Determine the type of research that applies to the project: 

Non-Human Subject Research (NHSR) - Human Subject Research

Clinical Trial\Non-Clinical Trail  

Clinical Trials conducted under the oversight of the Morgantown Health Sciences Campus may have additional requirements. Contact the  WV Clinical Trial Center of Excellence for more information.

2. Determine the Submission Category

NHSR\Flex, Exempt, Expedited, Full Board, Amendment, Continuing Review

Data Requirements

Determine the type of data that will be used for the research project (PHI, PII, PI, De-Identified, Sensitive Research Data) and ensure that you are aware and knowledgeable of the protection and privacy requirements for the data. A Data Use Agreement (DUA) may be required prior to IRB approval or IRB approval may be required before the DUA is completed. 

For information on DUAs contact WVU Office of Sponsored Programs, for information on obtaining data sets contact the WVCTSI

If you are unsure of the requirements for your project, review the WVU HIPAA Hybrid Entity Policy and the WVU and WVU HSC  institutional policies for Information Privacy and Protection. Then complete and email the Data Intake Form to irb@mail.wvu.edu or contact WVU OHRP. 

Collaborative Research - Multi-site or Multi-center Research

Determine if an IRB Authorization Agreement (IAA) or a letter of permission is required for the project. For more information visit the Collaborative Research section of this website under Pre-Approval Registrations and Templates. 

Bio Specimens -  Onsite Tissue and Data Repositories

For information on Tissue and Data Repositories, contact WVU OHRP or complete the Tissue and Data Repository Form and send it to: irb@mail.wvu.edu. 

Available PI Tools - 

Use the links below to find information and access to the tools listed below. Note that some access requests require approval and in some cases funding, please plan accordingly.

Qualtrics, REDCap, HIPAA Compliant Zoom, Protocol Builder,  Sample Project Templates

S TEP 3 - Create a Protocol Submission Application

Students:  Refer to the Student Quick Start Guide

1. Develop your protocol submission application using WVU+kc.

    Begin the application by clicking Create Protocol from the main menu. Note that the questions in the WVV+kc protocol management system are not considered a protocol document.  Some projects  are required a protocol document to be uploaded with the protocol application. If you are unsure, contact us.

2. Use Protocol Builder to assist with developing a protocol document.