The information below applies only to sites and facilities that have submitted the feasibility questionnaire and subsequently received email approval from the ALZ-NET Operations Team. You are not permitted to begin the site activation process until you have received a formal invitation to do so.
Follow the instructions below to activate your participating site in the Alzheimer’s Network. In order to receive a formal invitation, you must fill out the Site Registration and Feasibility Survey.
Please note that all steps below can occur simultaneously in order to expedite the startup process:
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 firstname.lastname@example.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 email@example.com 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.
- Contact firstname.lastname@example.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.
4. Human Subject Protection (HSP) Training: HSP Training must submitted when the user registers for CTMS (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 (CTMS)
- CTMS serves as the case registration application for ALZ-NET.
- The upload of Human Subject Protection (HSP) Training is mandatory during CTMS User Registration. Please see Step 4 for more information on obtaining HSP Certification.
- CTMS 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. Protocol Training Acknowledgement Form
- Please complete the appropriate Protocol Training Acknowledgement Form and return to the ALZ-NET Operations Team at email@example.com.
8. Provide the ALZ-NET Operations Team with Site EFT Vendor Information and W-9
Once all necessary steps have been completed by the participating site, the site will receive a formal activation memo that provides authorization to consent and register patients into ALZ-NET. At this time, site startup funding will be processed for remittance.