Getting Started

ESETT Study Team Members

NETT Hubs & PECARN Sites

NETT Spokes

Key ESETT Contacts

 

ESETT Study Team Members 

Obtaining a UM Friend Account

New study team members need a UM Friend Account to access all of the NETT's trainings and resources. Do you have a UM Friend Account? If not click here for instructions on how to create one.

 

Obtaining ESETT WebDCU Access (NOTE: Access to WebDCU is separate from ESETT.org).

Step 1: You will need a UM Friends account to initiate this request (see Obtaining a UM Friends account above).

Step 2: If you are the study: PI, Co-I, Primary Coordinator, Pharmacist OR if you plan to use the ESETT WebDCU database to: randomize, enter CRF data (or SAE’s), manage study drug, upload and maintain regulatory documents, or view study progress reports, etc., you will need access to ESETT WebDCU.  Please refer to the Regulatory Parameters Document for a complete list of required trainings based on role(s) and responsibilities. The Regulatory Parameters Document is available in the Toolbox (under the Study Team ONLY tab on the left). 

Step 3: Complete the relevant training modules available in Education and Training (under the Study Teams ONLY tab on the left). 

Step 4: Team members that have completed the WebDCU Data Training module can request access to ESETT WebDCU by notifying Cassidy Conner, ESETT Data Manager.

A list of WebDCU user resources are also available in WebDCU under the Toolbox Tile.   

 

Bookmarks

Bookmark these most commonly referenced NETT-affiliated websites:

NETT

WebDCU™

ESETT

NETT Standard Operating Procedures

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NETT Hubs & PECARN Sites

Once you have a UM Friend Account you can begin completing the study start-up activities found in the NETT Hubs & PECARN Sites Milestone Document.

EFIC and Regulatory resources required to complete study start-up activities are located under the IRB, CC & PD links above.

EFIC Assistance

Contact Deneil Harney, (734-232-2132), NETT EFIC Liaison, to assist with personalizing EFIC Plans and preparing CC and PD materials necessary to meet your local needs.

General Study Start-Up and Regulatory Assistance

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

While preparing your IRB application, People and Spoke regulatory documentation can be entered into the WebDCU™ study database. The goal is to be ready to enroll, including being regulatory and training compliant as documented in WebDCU™, prior to full study IRB approval.

Are you a NETT Hub bringing up an ESETT Spoke?

Consult the Hub/Spoke Complex SOP for bringing up new Spokes within the NETT Network.

Notify SDMC Data Manager, Cassidy Conner, and NETT Site Managers at, ESETT-milestone@umich.edu, of all new Spokes that you intend to bring up for ESETT. You will not be able to upload documents for Spokes until this occurs.

To assist new Spokes preparing for ESETT, provide them with the ESETT NETT Spokes Milestone Document.

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.

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NETT Spokes

Complete the activities listed above under Hub and Spoke Team Members.

Consult with your Hub to enter all Spoke study team members into the WebDCU™ study database for their roles in ESETT in the Project Spoke Team Member table. You will not be ready to upload documents for team members until this occurs.

Next, consult the ESETT NETT Spokes Milestone Document for a comprehensive list of activities to begin working on toward study activation.

EFIC Assistance

Contact Deneil Harney, (734-232-2132), NETT EFIC Liaison, to assist with personalizing EFIC Plans and preparing CC and PD materials necessary to meet your local needs.

General Study Start-Up and Regulatory Assistance

Contact ESETT-milestone@umich.edu, (734-232-2142), to reach a Site Manager.

While preparing your IRB application, People and Spoke regulatory documentation should be entered into the WebDCU™ study database per the ESETT Regulatory Parameters Document. The goal is to be ready to enroll, including being regulatory and training compliant as documented in WebDCU™, prior to full study IRB 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 ready to begin (per completion of the NETT Spokes Milestone Document, please notify your Hub. The Hub should then contact their NETT Site Manager for ESETT, to schedule a readiness call.

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Key ESETT Contacts

Emergency 24-Hour Study Hotline: 1-855-ESETT-PI (373-8874)

 

Education (training, website access, material development)

Joy Black (734-232-2138)

 

WebDCU™ Support (user account requests, technical support, CRF completion)
Cassidy Conner (843-876-1105)

 

EFIC (individual site EFIC support, and CC & PD results reporting in WebDCU™)

Deneil Harney (734-232-2132)

 

Site Management

ESETT-milestone@umich.edu (734-232-2142)

Erin Bengelink (734-232-2137)

Arthi Ramakrishnan (734-936-2454)

 

Finances

NETT Valerie Stevenson (734-232-2131)

PECARN ESETT_invoices@virginia.edu

 

For a comprehensive list of contacts go to the Who to Contact page on the NETT website.

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