Our welcome and introduction video to the course + PDF slides + Glossary + Course Workbook.

Overview of Clinical Research +PDF Slides

Background information about the process of drug development + PDF Slides.

Explanation of different design and how study objectives and endpoint shape studies +PDF Slides

Uncover the process of study feasibility and site selection + PDF Slides + SSV site brochure checklist.

Best practices to get a study started at a site and set up of operational tools + PDF slides + study kick off checklist.

Understand the process of negotiating study budget and executing contracts to get study started + PDF slides + study budget review form.

How to get study ethics submission and approval +PDF Slides + ethics submission review checklist.

Everything that happens during a study initiation at a site + PDF slides + Dry Run Checklist +Initiation Checklist

Understand the involvement of external vendors that support the clinical trials and how to manage them at site + PDF slides + Vendor Contact List Template.

The importance and how to develop site processes to handle clinical trials operations + PDF slides + List of Processes

A comprehensive overview of all processes and activities that take place during study conduct + PDF slide + funny animation video of a day to day site operations

Learn about different strategies of patient recruitment and the process to identify and put those in place +PDF Slides + Patient recruitment Strategy Form.

Learn how to perform the main patient activities such as consent, eligibility criteria review, safety monitoring, and types of study visits and it’s purpose + PDF slides + General study visit reference guide.

Master the process of managing study investigational product + PDF slides + IP Management Checklist.

Learn how to proper monitor, document and report safety events in clinical trials +PDF slides + Safety Reporting Checklist.

A description of site processes to handle biological samples, from set up to collection to shipment and results reporting + PDF slides + Sample Tracker template

Understand the importance and how to handle clinical trials data: source documents and electronic data capture systems + PDF Slides + Data Management Checklist.

Learn how to deal with protocol deviations and best practices to manage issues and prevent reoccurrence + PDF Slides + Issue Management Form Template.

Learn how to manage study documents and remain audit ready at all times + PDF slides + Site File Tracker template.

Learn the process to get protocol amendments approved and implemented at site +PDF slides + Amendment Implementation Checklist.

Understand the importance and how to prepare for monitoring visits and adequately resolve action items + PDF Slide + Monitoring Visit Checklist.

Understand the process and how to manage study database locks like a pro + PDF Slides + Database Lock Checklist.

How to organize and complete study close out at site + PDF slides + Close Out Checklist.

How to track and invoice sponsor for study payments +PDF Slides + Payment Checklist.

Prevent is better than correct. Learn how to identify, assess and mitigate risks at site + PDF slides + Risk Assessment Quick Reference Guide.

Learn the process to ensure quality at site + PDF slides + Quality Review Sample Checklist.

Understand the importance and how to ensure investigator oversight + PDF Slides + PI Oversight Task Checklist.

Course conclusion and certificate.