Getting Started

HOBIT Study Team Members 

Step 1: Create a UM Friends Account (if you don't already have one)

New study team members need a UM Friend Account to access all of the HOBIT and Network trainings and resources. Click here for instructions on how to create one.

 

Step 2: Review the HOBIT WebDCU User Account & Regulatory/Essential Document Process Guide

The HOBIT WebDCU User Account & Regulatory/Essential Document Process Guide is found on the Education and Training page. 

 

Step 3: User account/permissions for WebDCU (HOBIT Database)

Regardless of whether the study team member ever expects to access the HOBIT WebDCU database, each study team member must have a WebDCU User Account in order for the Primary Study Coordinator and/or the Site Regulatory Coordinator to be able to upload the regulatory documents that must be placed before the trial can start at the clinical site.

Please refer to the HOBIT WebDCU User Account & Regulatory/Essential Document Process Guide sections 2 (User Account Management in WebDCU) and 2.1 (Creating User Accounts).

 

Step 4: Completing the eDOA Log (electronic Delegation of Authority Log) 

Once user permissions have been approved for a site team member, the team member can be added to the eDOA log. This is where the Primary Study Coordinator will select the role and responsibilities that each site team member has been delegated by the PI. The eDOA must be submitted in order for regulatory document requirements to populate for study team members.

Please refer to the HOBIT WebDCU User Account & Regulatory/Essential Document Process Guide section 2.2 {Completing the Electronic Delegation of Authority (DOA) Log}.

 

Step 5: Required Trainings for WebDCU and HOBIT using the Regulatory Parameters Document  

Please refer to the Regulatory Parameters Document for instructions for uploading People and Site Documents for HOBIT.  A complete list of required trainings based on role(s) and responsibilities is also found in the Document. The Regulatory Parameters Document is available at the top of the HOBIT Education and Training page

 

Step 6: Complete Regulatory Document Records in WebDCU

All team members MUST be added to the 1) HOBIT Database AND 2) the eDOA, BEFORE all regulatory documents can be fully displayed for completion, please see above. 

Please refer to the HOBIT WebDCU User Account & Regulatory/Essential Document Process Guide section 4.1 (Submitting Regulatory/Essential Documents).

 

General Study Start-Up and Regulatory Assistance

Contact: HOBIT-milestone@umich.edu or (734) 232-2142 to reach a Site Manager.

 

Bookmarks

Bookmark these most commonly referenced SIREN-NETT-affiliated websites:

​SIREN

WebDCU

HOBIT

SIREN Standard Operating Procedures

 

Are you a SIREN Hub bringing up an HOBIT Spoke?

  • Consult the Hub/Spoke Complex SOP for bringing up new spokes within the SIREN-NETT Network.
  • Notify SDMC Data Manager, Jodie Riley or Teldon Alford, and HOBIT Site Managers at, HOBIT-milestone@umich.edu, of all new spokes that you intend to bring up for HOBIT. You will not be able to upload documents for spokes until this occurs.
  • The Hub is responsible for making sure all the spoke tasks are met. However, the Hub can tailor the process to meet their Hub/Spoke Complex relationship in accordance with the Hub/Spoke Complex SOP.
  • Please note: If your Hub will be an actively enrolling site, it will be considered a spoke in the WebDCU regulatory and study databases. Instructions for spokes below would then apply to the Hub as well.

 

Are you a SIREN Spoke?

  • Consult with your Hub to enter all spoke study team members into the WebDCU study database for their roles in HOBIT in the Project Spoke Team Member table. You will not be ready to upload documents for team members until this occurs.
  • While preparing your CIRB application, People and Spoke regulatory documentation should be entered into the WebDCU study database per the HOBIT Regulatory Parameters Document. The goal is to be ready to enroll, including being regulatory and training compliant as documented in WebDCU, prior to study CIRB approval. Please check with your Hub contact to confirm what your Hub/Spoke complex process will be for documenting and maintaining regulatory compliance in the WebDCU study database.
  • When you are regulatory ready, the Hub should then contact their SIREN Site Manager for HOBIT, to schedule a readiness call.