Step 1. Complete a A3-45 Personnel Sheet
What is it? The Personnel Sheet captures information for each study team member, including role, delegated duties, required certifications and study data access. It must be signed by the PI.
Where is it? Personnel Sheets and instructions can be found in the Data Portal. If you need access, contact the following:
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North America sites: a345-study@atrihub.io
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Rest of World sites: Your regional clinical operations lead
Contact information for new staff will be needed in some instances, e.g. for PIs and Study Coordinators or staff requiring access to the Data Portal.
Step 2. Access Systems
ATRI AHEAD 3-45 Data Portal
Access study documents, e.g. Protocol, ICF, Procedures Manual, MRI and PET Tech Manuals, SAE Reports, Personnel Sheet, Coordinating Center Contact Info, Accountability Log.
Register participants, enter study data, report AEs, SAEs, and protocol deviations, respond to queries.
NOTE: Access is granted based on Personnel Sheet details. ATRI EDC Certification is required for most account types.
Not sure if you have an account? Contact the following:
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North America sites: a345-study@atrihub.io
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Rest of World sites: Your regional clinical operations lead
Step 3. Get Assistance
Once you’re set up:
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Check the Procedures Manual – this document has a wealth of information.
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If you have questions, contact the following:
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North America sites: a345-study@atrihub.io
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Rest of World sites: Your regional clinical operations lead
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Please reference the AHEAD 3-45 Study Contact Sheet in the EDC for additional contact information.
Step 4. Additional Information
For more information about AHEAD 3-45, visit the study website at https://www.aheadstudy.org/.