Research & Economic Development

Office of the Vice Chancellor

eProtocol FAQs

  • What if I or a member of the research team is not currently in the system?

    • This can be handled by clicking on the Register button on the eProtocol landing page and completing the New User Registration Form.
    You will receive an email, including your login and temporary password, from the IRB office once you have been added to the system.
    • You may also add someone into the system by entering their information in the section titled "Other Personnel".  Once the IRB administrative staff receives the application those research personnel listed can be permanently added to the system. 
      • This method is less ideal as you will not be able to most appropriately designate that individual into their appropriate role.

     Screen Shot of eProtocol landing page identifying the Register button

  • Who can create or edit a protocol?

    Those listed in the protocol as Principal Investigator, Co-Principal Investigator, Student or Postdoctoral Investigator, Administrative Contact, and Other Contact can create and edit a protocol. Those listed as Other Personnel will only have viewing access to the protocol.

  • Who can access eProtocol?

    If you have been issued a login and password you can access the system.  Persons not affiliated with UMKC must be entered through the application process (via the "Other Personnel" section of the application) and subsequently provided a login and password.
  • Are the other investigators required to "sign" the protocol as in the past?

    Yes.  Each investigator must sign off acknowledging their participation as an investigator on the protocol.  This may be accomplished by attaching a single page containing all investigator signatures or individual signature pages.
  • Who can submit the protocol?

    A protocol may be submitted by a Principal Investigator, Co-Principal Investigator, Student or Postdoctoral Investigator, Administrative Contact, or Other Contact. However, before the eProtocol system will permit the protocol to be submitted, the Principal Investigator or must log into the system and check the appropriate box in the Obligations section of the protocol. This requirement exists as an electronic substitute for an ink signature from the Principal Investigator or Faculty Sponsor.
  • Who can be listed as Principal Investigator (PI)?

    The person listed on the protocol as PI must be eligible under University policy to submit proposals for extramural support of a research, training, or public service project, and to perform research involving human subjects.

    • Residents, Post-Docs, Students are not eligible to be PIs under University Policy

    As a general rule, the PI on the grant funding the research must be listed as PI on the application.

  • What should I name the documents I upload as a part of my application?

    Consent/Assent Sections:

     

    Please upload all consent documents as Word documents. Name all documents according to the following naming convention:

    • Document Type/Title (e.g., Consent Form, Consent Information Sheet, etc.)_Version/Edition #_Version/Creation Date

    Ex: Adult Consent Form_Version 1.5_10-18-2012

     

    Do not use the date the document was submitted/uploaded into the eProtocol system. This date is already captured by the submission system. Consistency is important, as the filename will appear as uploaded on the study Approval Letter.

     

     

    Attachments Section/Everywhere Else:

     

    Please upload all documents individually. Name all documents according to the following naming convention:

    • Document Type/Title (e.g., Investigators Brochure, Recruitment Flyer, Beck Depression Inventory, etc.)_Version/Edition #_Version/Creation Date

    Ex: Investigators Brochure_Version 1.0_10-18-2012

     

    Do not use the date the document was submitted/uploaded into the eProtocol system. This date is already captured by the submission system. Consistency is important, as the filename will appear as uploaded on the study Approval Letter. For study measures, use acronyms only if the title is more than three-four words long.

     

  • How are the personnel roles in eProtocol defined?

    Principal Investigator (PI)
    The Principal Investigator is the person who has primary responsibility for the design, execution, and management of a research project and is involved in the project in a significant manner. The PI is also responsible for the protection of the rights and welfare of the human subjects and adherence by all study personnel to UMKC requirements, as well as applicable university policies, state statutes, and federal regulations.

    Other Investigator
    This can be a Sub-Investigator, Co-Investigator, Student Researcher, Resident or Fellow. Student, Resident, and Fellows acting as Investigators are not considered by UMKC to be the PI on any research project.

    Study Coordinator
    The individual who most often has the responsibility of monitoring the day to day operations of the research study.  Although the PI is responsible for the conduct of the research, it is often the Coordinator who carries forward the research goals, thereby playing a significant role in the success of the research study. Most importantly, Coordinators are often involved in conducting the informed consent process and ensuring compliance with the protocol.  Although not inclusive, some of the Coordinators responsibilities include preparing the Institutional Review Board submission, helping to design the informed consent document, working with the institutional official in contract negotiations, subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the IRB as necessary and study close-out.

    Administrative Contact

    The Administrative Contact is an individual who has administrative responsibilities on the project and/or is the administrative assistant for the PI. The Administrative Contact could also be one of the study personnel.

    Other Personnel
    Other (Study) Personnel includes any individual who contributes in a substantive way to the design, conduct, and/or analysis of the data of a study at or on behalf of UMKC that does not meet one of the criteria identified above.  In addition, this Personnel section is designed to capture individuals not currently found in the UMKC eProtocol system. 

  • How will I know if the IRB has questions about my protocol or when my protocol has been approved?

    eProtocol generates automated emails at each step of the review process. However, the email notices will only be sent to personnel listed on the study.  The emails will include links to relevant instructions (for example, how to respond to comments, how to print the approval letter).
  • Can I submit an Amendment and Continuing Review application at the same time?

    The system will not allow a study to have simultaneous Amendment and Continuing Review applications. Please begin a Continuing Review application as amendments can be proposed in that application as well. If any Amendment Applications have already been started, you must withdraw them before eProtocol will allow you to begin a Continuing Review application.
  • Can I maintain my current IRB# if I submit for Continuing Review through eProtocol?

    No.  The eProtocol system will automatically generate a new number for your submission.  To keep track and "link" the new number to the old, the IRB requests that you add the current IRB number to the title in the eProtocol application.
  • How do I submit for Continuing Review in eProtocol?

    You must first submit an initial application.  Once the IRB receives the application it can be administratively approved.  This is not a Continuing Review approval.  It means that the application has been prepared for you to submit under Continuing Review.  Once the administrative approval has occurred you can then enter the eProtocol system and submit your study for Continuing Review. 

    The eProtocol system will automatically generate a new number for your submission. To keep track and "link" the new number to the old, the IRB requests that you add the current IRB number to the title in the eProtocol application.
  • How do I get my approval letter?

    1. Login to the eProtocol system and proceed to the approved study in question. 
    2. Click on the Protocol ID link.
    3. Click on Open in View Mode.
    4. Click on Event History in the side panel.
    5. The Event History will show the review history of the protocol including attachments and approval letters associated witht he various iterations of the protocol.
    6. Click on the Approval Letter link.  The Approval Letter will open as a PDF file.