Overview
Welcome to ALZ-NET! Explore the ALZ-NET Site Operations Toolkit, your comprehensive guide to successfully participating in the Network. From site startup to data collection, this toolkit provides step-by-step support to help streamline processes, answer common questions, and optimize your site's ALZ-NET activities.
- 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.
- Prior to completing start-up activities, we recommend reviewing the Site Start-up Flowchart to better understand how each start-up component will be handled at your site.
- 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 TrainingSite Operations ToolkitAttend 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
3. Human Subject Protection (HSP) Training:
- HSP Training must submitted when the site user is registered in the ALZ-NET Portal (see Site Activation Checklist Step 4).
- 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
- Human Subjects Protections Training
4. Add Staff in the ALZ-NET Portal for Access to Case Registration.
- In the ALZ-NET Portal, the Site Administrator who registered the site will need to 1) complete their staff registration profile and 2) add site staff via the Staff List Tab. Once the site is activated, a site will return to the Portal to register new patients.
- ALZ-NET Portal Training Guide for Site Staff.
5. 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 ALZ-NET Portal is the email that you would like to register with Medidata Rave.
- Medidata Rave Training Module
6. Review Protocol Training Module. Email Protocol Training Acknowledgement Form for Principal Investigators and Site Support Staff to alz-net@acr.org.
7. Provide the ALZ-NET Operations Team with Site Electronic Funds Transfer (EFT) Vendor Form and W-9 template via secure Box link.
8. Install TRIAD Application for Image Upload (if applicable to site's operations)
