Site Activation

Overview

Welcome to ALZ-NET! Sites that have received email approval from the ALZ-NET Operations Team are invited to complete the Site Activation Checklist below. If you have not received a formal invitation to participate, please email alz-net@acr.org or review instructions for Joining the Network. All steps below can occur simultaneously in order to expedite the startup process. 

Sites who complete all activation steps will receive a formal activation email from ALZ-NET that provides authorization to consent and register patients.  At this time, site startup funding will be processed for remittance.

Schedule Protocol TrainingDownload ChecklistAttend Office Hours

Site Activation Checklist Details

1. Full execution of ALZ-NET Research Agreement

• The ALZ-NET Research Agreement is provided as part of the welcome email from the ALZ-NET Operations Team.
• If your site would like to propose revisions to this Research Agreement, please do so in the provided document using the track changes functionality and return the redlined document.
• If this Research Agreement is acceptable to your site as presented, please edit the highlighted fields, and signature block and return the document. We will then package and send a DocuSign email to your site for signature.
• Contact alznet-contracts@acr.org with any contract specific questions or edits.

2. IRB Approval via Advarra IRB

• All participating sites must use Advarra IRB as the IRB of record overseeing their research activity. Local IRBs are not permitted to serve as the IRB of record for ALZ-NET, however the study team understands that local IRBs may need to review and acknowledge, per local policy, before a site is fully active to enroll. Read more information on IRB Approval.

Informed Consent Form

• The ICF is provided as part of the welcome email from the ALZ-NET Operations Team.
• Any changes made to the ICF, outside of the highlighted fields within the document, must be approved by the ACR. If changes are required, please email a tracked change document to alznet-regulatory@acr.org and wait for approval. If no additional changes are needed, the Advarra IRB will fill in the highlighted fields for you when you submit your initial application.
• Advarra IRB Guidance on Remote Electronic Signatures
• ALZ-NET Guidance for Electronic and Remote Informed Consent
• Contact alznet-regulatory@acr.org with any regulatory questions or edits.

3. Staff Registration Survey via RedCap: 

• This survey is to collect required information on site investigators and staff. This survey also informs the ALZ-NET Operations Team as to which staff need access to Network applications.
• Staff Registration Survey

4. Human Subject Protection (HSP) Training: 

• HSP Training must submitted when the user registers for RMS (below).
• If training is needed, ACR will cover the cost through affiliation with CITI. Users may affiliate with the American College of Radiology during their CITI registration process in order to complete the “Human Subject Research – Basic” course, free of charge
• Please see Human Subjects Protections Training for instructions

5. Register for Access to Case Registration Platform (RMS)

• Research Management System (RMS) serves as the case registration application for ALZ-NET.
• The upload of Human Subject Protection (HSP) Training is mandatory during RMS User Registration. Please see Step 4 for more information on obtaining HSP Certification.
• RMS Training Module

6. ALZ-NET Operations Team grants access to Electronic Data Capture (Medidata Rave)

• Medidata Rave serves as the electronic data capture (EDC) for ALZ-NET
• Each site staff member that will be entering in participant clinical data must have a Medidata Rave account to do so.
• Please ensure that the email address entered for each site staff member in the Staff Registration Survey is the email that you would like to register with Medidata Rave.
• The ALZ-NET Operations Team will use the provided email(s) to register each user.
• Medidata Rave Training Module

7. Review Protocol Training Module. Email Protocol Training Acknowledgement Form for Principal Investigators and Site Support Staff to alz-net@acr.org. 

8. Provide the ALZ-NET Operations Team with Site Electronic Funds Transfer (EFT) Vendor Form and W-9 template via secure Box link.