Access for External Monitors to Advarra eRegulatory at Michigan Medicine

• U-M – U-M means the University of Michigan.
• Michigan Medicine – Michigan Medicine is the University of Michigan’s academic medical center.
• U-M ID Number or UMID – Your U-M ID number, also called your UMID, is the identification number assigned to you by the University of Michigan.
• U-M Uniqname – Your U-M uniqname is your University of Michigan username. For Michigan Medicine systems, you may need to enter it in this format: [email protected]
• UMICH Password – Your UMICH password is the password for your University of Michigan account.
• Personal Identifiable Information (PII) – Information securely collected by the University of Michigan in order to verify a monitor’s identity. For access to CTMS software systems, this includes name, date of birth, address, email address, and biological sex.

• Please read all emails and complete all required steps promptly.
• Delays in responding may delay your U-M login credentials and access to Michigan Medicine software applications.
• Account setup requires several steps, some of which are time-sensitive.
• Throughout the process, you will receive emails from two separate teams:
  • CTMS team ([email protected]) – These informational emails will help guide you through the process and provide helpful instructions.
  • Michigan Medicine Identity Management Team ([email protected]) – These automated emails provide information about your identity verification status and U-M login credentials.

All external monitors are required to provide information needed to verify their identity before receiving access to eReg at Michigan Medicine. This includes your name, date of birth, address, email address, and biological sex.

Additionally, external monitors must attest to having read the Responsible Use of Information Resources SPG 601.07 policy and provide proof of HIPAA training. 

1. The CTMS team will send a short, secure survey to collect your personal identifiable information.
2. You will complete the survey, attest to reading the Responsible Use of Information Resources SPG 601.07 policy, and provide proof of HIPAA training. 
3. The CTSU account approvers will submit a request for U-M login credentials to the Michigan Medicine Identity Management team.
4. The Michigan Medicine Identity Management team will send an email containing your U-M login credentials within 1-3 business days.

The email from the Michigan Medicine Identity Management team containing your U-M login credentials will include:

• Your U-M ID number, also called your UMID
• Your U-M uniqname, which is your University of Michigan username
• A temporary password, which is your 10-digit phone number (without dashes) and valid for 21 days

It is important to save this email. You will need this information if you contact the Michigan Medicine Service Desk for assistance.

Follow the instructions in the email to:

1. Set up your U-M account
2. Choose a new password
3. Enroll in two-factor authentication with Okta Verify

Two-factor authentication using Okta Verify is required to connect to Michigan Medicine systems, a security step that helps protect your account.

To enroll your mobile device, see Okta Help.

There are two required training modules that must be completed before your eReg account can be created:

1. Michigan Medicine Compliance (institutional mandatory)
   1. Note: The User Profile is not a requirement; do not complete this questionnaire.
2. eReg for Monitors, Auditors, and Sponsors (eReg-specific training)

The Michigan Medicine Compliance training:

• Is required for anyone who needs access to Michigan Medicine systems, including external monitors who need access to eReg. 
• Takes about 30 minutes
• Must be retaken annually to retain U-M login credentials and access to eReg

The course explains key compliance requirements that apply to anyone accessing Michigan Medicine data, including privacy, protected health information (PHI), business ethics, conflicts of interest, financial transactions, the Code of Conduct, and how to report compliance concerns. 

The eReg for Monitors, Auditors, and Sponsors training is:

• Specific to using eReg at Michigan Medicine
• About 25 minutes in length

This course will instruct monitors, auditors, and sponsors of clinical trials how to conduct review sessions in eReg, including how to navigate the eReg system, and view or download protocol documentation.

Around the time you receive your U-M login credentials, the CTMS team will send an email with instructions to complete training.

Both modules are completed in Cornerstone, Michigan Medicine’s online learning system.

To log in and complete training, see Cornerstone – Access to Cornerstone: Instructions

After Michigan Medicine Compliance training completion is verified, you will be given access to eReg within 2 business days. 

You will receive an email with further instructions from the CTMS team at that time. eReg users at Michigan Medicine will need to take additional steps to activate their user account. 

Activate Your eReg Account

1. Open the one-time activation email from [email protected]
2. Select the “Confirm your account” link.
3. A Michigan Medicine Microsoft sign-in page will open.
4. Confirm that the sign-in field shows [email protected]
   1. If the field is blank, enter [email protected]
   2. If the field shows another account, follow these steps:
      1. Select “Sign out and sign in with a different account.”
      2. Enter [email protected]
5. Enter your UMICH password.
6. Complete two-factor authentication.
7. After you sign in successfully, the application will open.

If you did not receive the activation email, or if you need a new activation email, submit a support ticket through the CTMS Service Catalog.

Study teams set up review sessions directly in eReg, allowing you secure access to specific protocols via assigned review sessions.

eReg is 21 CFR Part 11 compliant for electronic signatures. When a document has been electronically signed, the signature details appear on the last page of the document. If the document has been configured to have signatures placed in specific locations, such as a consent form, the signature details will appear alongside the signature.

• Log in to eReg. 
• Navigate to Menu / Review Sessions.
  • Optional: Select the star icon to add Review Sessions to your Favorites Bar.
• Review your assigned sessions. Each session includes a Start Date and Stop Date.
  • Access begins at 12:00 am on the Start Date
  • Access ends at 12:00 am on the Stop Date
• Select a review session to view the protocol information.

On the Summary page, you can:

• Scroll through the page to review session details, protocol sections, and documents
• Use the left-side navigation menu to move directly to a specific section

Some sections include additional documents or details.

Organizations 

Select an organization name to view the regulatory tracking items and related documents. If multiple versions are available, each version appears in a separate row.

Staff

Select a staff name to view the staff member’s staff role, credential documents, and signature status. If multiple versions are available, each version appears in a separate row.

Subjects

Select a subject number to view subject information, source documents, and signed consent forms.

Participating Sites

For multi-site protocols, select Participating Sites to view the sites included in the review session. Select a site name to view site information and related documents.

Documents

To open a document, select the file name hyperlink or the corresponding document icon.

Action	Description
	Downloads the document. Opens in a new browser tab.
	Opens related documents in a new browser tab.
	Opens view-only documents in a PDF viewer.
	Opens an external website or resource.
	Opens the signature details page in a new browser tab.
	Opens the consent form signature in a PDF viewer.
	Opens comments associated with the document.

1. Open the review session.
2. In the upper-right corner of the page, select Action / Download Documents.
3. In the Choose Sections for Export window, select the sections you want to download.
   • SOPs and Subjects are not available for download.
   • The approximate total export size appears at the bottom of the window
   • If the total exceeds 500 mb, an error message appears.
4. Select Download Documents to download the zipped file.

Download Notes

• Only one download task can run at a time. 
• Additional download requests are placed in the Queued Tasks window with a status of Submitted.
• The top-level folder is named after the protocol.
• Subfolders are named after the sections that contain documents. 
• Sections with no documents are not included in the zipped file.
• Documents are saved using their file names, not their document names.
• Downloaded documents include signature information when available.

To maintain your U-M credentials and access to eReg, the following must be done on an annual basis:

• The department sponsoring your account will verify your continuing need for U-M credentials. Verification methods include:
  • Recent participation in a meeting or review session
  • Recent email correspondence showing company email address
  • Verification by employer or manager
• You will complete the annual Michigan Medicine Compliance training

Notify the study team immediately if you no longer need your U-M credentials or access to eReg. They will submit a deactivation request on your behalf.

Michigan Medicine Service Desk

The Michigan Medicine Service Desk is available 24 hours a day, 7 days a week by calling 734-936-8000, option 3.

Before calling, have the following information ready:

• Your U-M ID number
• Your U-M uniqname

The Michigan Medicine Service Desk can help with:

• U-M account set-up
• Two-factor enrollment and authentication
• Connecting to Windows Virtual Desktop
• Cornerstone, Michigan Medicine’s online learning system
• Password resets
  • Reset Your Own UMICH Password: Account Self Service (requires U-M uniqname)

CTMS Team

The CTMS team is available during regular business hours, Monday through Friday. Submit a ticket directly to the team using the CTMS Service Catalog.

The CTMS Team can help with:

• General questions
• 1Kosmos initial login credentials
• 1Kosmos denied verifications and exception requests
• Software application access & support
• Activation emails for Advarra applications
• Account deactivations

Responsible Use of Information Resources SPG 601.07: Policy
Cornerstone – Access to Cornerstone: Instructions
Reset UMICH Password: Account Self Service (requires U-M uniqname)