This module guides you through assembling the regulatory and IRB submission package for the CARDIO-PROTECT trial using Microsoft Word, Excel, and SharePoint. You'll create a compliance checklist, IRB document inventory, and consent verification, plus validate a pre-completed ALCOA+ documentation form by identifying errors and recommending corrections. This package proves to the sponsor that your site has regulatory approval, proper documentation, and a compliant consent process ready for participants; it's always the first thing reviewed at a site initiation visit.

This module guides you through creating a study design and GCP compliance review for the CARDIO-PROTECT trial. You'll annotate the research framework, assess methodology alignment, and verify GCP compliance, plus validate a pre-completed ethics risk assessment by checking whether risks are correctly identified and escalation actions are appropriate. This component demonstrates to the sponsor that your team understands what the study is designed to accomplish and how to conduct it correctly.

This module guides you through building the operational coordination plan for the CARDIO-PROTECT trial. You'll create a visit calendar for incoming participants, establish a communication tracking system, and define data handling procedures, plus validate a pre-completed assessment checklist by verifying responsibility assignments against the delegation log. This component proves to the sponsor that your site can manage active participants effectively from day one of enrollment.

This module brings everything together. You'll review and refine all components for consistency, create a brief cover summary that introduces your site startup package, and submit the complete package as your graded capstone deliverable. You'll also reflect on your learning journey and identify next steps for your clinical research career.