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LEADS Quick Start Guide

Step 1.  Complete a LEADS 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 leads-study@atrihub.io.

Contact info 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 LEADS Data Portal

Access study documents, e.g. Protocol, ICF, Procedures Manual, MRI and PET Tech Manuals, SAE Reports, Personnel Sheets, 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 leads-study@atrihub.io.

 

Step 3.  Get Assistance

Once you’re set up:

  • Check the Procedures Manual – this document has a wealth of information.

  • Contact your ATRI Clinical Monitor – they are there to help.

  • Not sure who your monitor is or still have questions?  Contact the LEADS ClinOps Team at leads-study@atrihub.io.