header image

For Physicians Considering Clinical Trials: Online Investigator Training


Federal regulations mandate that pharmaceutical and biotechnology companies select Clinical Investigators who are qualified by training and experience as research experts. Our 100% online training program, How to Conduct Clinical Trials, will provide you with the required knowledge to become a Clinical Investigator.

Click HERE to view a demonstration version of How to Conduct Clinical Trials. A detailed course outline appears below.


You will learn:

- The role and responsibilities of the Investigator, Study Coordinator and the Sponsor

- The regulatory requirements for conducting clinical trials

- How to evaluate, prepare for and conduct clinical trial protocols

- How to interact with the Sponsor

- How to prepare study budgets for submission to the Sponsor


if you want to learn about conducting clinical trials at a hands-on, practical level, this is the course for you. The program takes approximately 18 hours to complete. Individual completion times will vary. There are no printed materials, and the course is entirely online. A full course outline is presented below.

Image courtesy of stockimages at FreeDigitalPhotos.net

You have been thinking about this for a long time. You can either take a one- or two-day course offered in a classroom and pay for hotel, meals and airfare, or you can take this online program totally online, which is equivalent to a three-day classroom program. Sign up today, and get started today!

 

COURSE OUTLINE

Module 1: Introduction

Module 2: The Drug Development Process

What is a Drug?

Drug Development

The Components of an IND

Clinical Development Plan

Phases of clinical Research

Regulatory Requirements & Guidelines

Declaration of Helsinki

Role of FDA

ICH Guidelines

HIPAA

Good Clinical Practice

Roles & Responsibilities

Sponsor's staff

Study Site Staff

Required Study Site infrastructure

Equipment

Study staff

Structure & role of IRB/IEC

Informed Consent process

Standard Operating Procedures


Module 3 Study initiation Activities

Study Site Staff's Evaluation of Study

Investigator Brochure

Protocol

Existing site facilities

Sponsor Evaluation of the Study Site

The Pre-study Visit

Study Site Documentation

Investigator's Essential Document File

Documents required for Study Initiation

Signed Protocol

Form FDA 1572

CVs

Financial Disclosure

IRB/IEC approval

Lab documentation

Study Document Review Simulation

Preparing the Study Budget

Managing Clinical Study Supplies

The Study Initiation Visit


Module 4: Ongoing Study Activities

Case Report Forms & Source Documents

Enrolling & Retaining Subjects

Performing Evaluations

Adverse Events

Sponsor Monitor Visits

Ongoing Reports

Drug Accountability (requirements & simulation)


Module 5 Study Close-Out Activities

Subject Completion/Termination

Sponsor Closeout Visit

Final Drug Accountability

Required Final Reports

Archiving the Master File

Sponsor & Regulatory Audits