This module teaches you how to verify that required approvals, staff authorization, and procedural documents are in place before or during study tasks using a structured audit checklist in Microsoft Excel. You'll conduct a mock compliance audit by reviewing simulated delegation logs and SOPs, then document findings with corrective action recommendations. Performing these checks is a routine coordinator responsibility that catches problems before monitors or auditors do.

This module explains how the IRB functions at each stage of a clinical trial from initial protocol review through continuing review, amendment oversight, and participant protection decisions. You'll complete a structured responsibilities brief template in Microsoft Word that outlines the IRB's role at each stage with regulatory references. Coordinators interact with the IRB constantly, and understanding its functions ensures timely submissions and compliant study conduct.

This module focuses on which documents and events must be submitted to the IRB and when. You'll populate a pre-formatted inventory template in Microsoft Excel that tracks all IRB-required materials for a sample trial scenario. Coordinators manage IRB submissions routinely, and knowing exactly what requires review prevents implementation of unapproved materials—a common compliance finding at study sites.

This module introduces the standard documents that must be maintained at a clinical research site to demonstrate proper study conduct and staff readiness. You'll cross-reference a simulated site file against a pre-formatted checklist in Microsoft Excel to verify document completeness during a simulated audit scenario. Knowing what documents are required and checking their completeness is one of the most frequent tasks a coordinator performs before monitor visits and inspections.

This module teaches you to apply ALCOA documentation principles, Attributable, Legible, Contemporaneous, Original, and Accurate, when completing clinical research records. You'll complete a sample documentation form in Microsoft Word that contains intentional errors requiring proper ALCOA corrections, then organize it in SharePoint with version control. Every entry a coordinator makes must meet these standards, as they determine whether data will withstand regulatory scrutiny.

This module covers what must be included in every informed consent form so potential participants can make a truly informed decision about joining a study. You'll complete a structured checklist template in Microsoft Word that identifies all essential consent elements, including descriptions and regulatory references. Coordinators must verify consent form completeness before use and explain each element to participants—making this knowledge fundamental to daily practice.

This module teaches you the step-by-step operational process of obtaining informed consent—from verifying you have the correct form version through documenting timing and filing the signed copy. You'll practice the consent workflow through a guided role-play scenario using Coursera Coach that simulates a real participant interaction. Executing this process correctly every time is non-negotiable for coordinators, as consent errors are among the most common and serious compliance findings at study sites.

This project integrates regulatory compliance, IRB submission, clinical documentation, and informed consent skills into a single site readiness package for a simulated Phase III cardiovascular trial. You'll assemble a compliance checklist, IRB inventory, ALCOA-compliant documentation form, and consent verification using Microsoft Word, Excel, and SharePoint — organized with proper naming conventions and version control. Assembling this package is the first real deliverable a new coordinator produces, and demonstrating site readiness before a sponsor's initiation visit is critical for earning study awards and beginning enrollment.