Course Outline

Monitoring Clinical Studies

1. INSTRUCTIONS FOR USE AND INTRODUCTION.

2. THE DRUG DEVELOPMENT PROCESS--this module was written to introduce potential and new Clinical Research Associates (CRAs) to how drugs are developed worldwide. If you are not familiar with the process, you will discover it to be a very long, very expensive, very regulated and extremely complex process. Many textbooks have been written describing the Drug Development Process. It is not our intent in this on-line program to compete with a textbook. As a CRA you should have an understanding and some knowledge of what occurs during the Drug Development Process. Your new employer will not require you to completely understand the Drug Development Process. Your role is part of the process and your responsibilities are what you will need to fully understand.

Few chemical compounds will make it from laboratory idea to available for sale on the pharmacy shelf. In fact, it is estimated that only one out of every five thousand compounds becomes available from the pharmacy. First, this section gives you an overview of the Drug Development process. Second, the regulatory bodies and governing processes are covered. Where HIPAA influences the Clinical Trial Monitoring process, it is included. This section explains what happens before a study is started, the role of the Food and Drug Administration (FDA), the role of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use---hereafter referred to as---ICH or ICH Guidelines. What constitutes Good Clinical Practice (GCP) is defined and covered. All companies have Standard Operating Procedures (SOPs) and the concept of SOPs will be covered here.

3. INITIATING THE STUDY-This module covers the characteristics of good clinical Investigators and the process of finding Investigators who meet the needs of the protocol. You will learn about site evaluation during Pre-study Visits to potential investigational sites. During the pre-study visit, the CRA describes the planned study to Investigators and evaluates the sites to make sure they are appropriate for the study. This section gets into the process of preparing for the study site visit, conducting the visit, and assessing the site. This visit is usually the final step in selecting Investigators for a clinical trial. Study Site Staff Training is also covered. During the Study Site Initiation visit, CRAs review the study protocol with the Investigator and the study site staff and discuss all sponsor/company and regulatory procedures. The CRA will inspect the supplies with the study site staff. If all goes well, at the end of the visit, the site will be ready to enroll subjects.

4. MONITORING THE STUDY-From the day the first subject is enrolled until the final study site visit, you will visit Study Sites regularly to make sure that the study is conducted according to the protocol and Good Clinical Practice (GCP). FDA regulations, ICH Guidelines and the sponsor's SOPs will be followed. This module gets into how to prepare for, conduct, follow up and report on monitoring visits. Also covered in this section are Adverse Events/Serious Adverse Events-what they are, how, when and who reports them. FDA and ICH Guidelines mandate Adverse Event reporting. You will learn the appropriate regulations and how to comply with them, the process for ongoing study site evaluation and the case report form review and correction process. Various means of dealing with study site issues are also discussed.

5. CLOSING THE STUDY-- This module gets into all activities involved in closing a study site. It explains how to plan and conduct the final study visit, and how to complete subsequent follow-up activities including retrieval and reconciliation of all study supplies, archiving study documentation and preparing the study site for a possible audit.

To gain the most from this on-line training program, you should study the modules in the order presented. There will be a test at the end of each section and a final exam. You will need to achieve a grade of 70% or higher in the Course Mastery exam in order to receive your Certificate of Completion.

MODULE ONE--INSTRUCTIONS FOR USE AND INTRODUCTION

MODULE TWO-THE DRUG DEVELOPMENT PROCESS

WHAT IS A DRUG?

Where Does a Drug Originate?

Steps in Drug Development

Pre-Clinical

Clinical Development

The Business Side of Drug Development

Regulating Drug Development

The FDA

Food and Drug Laws

Review Boards and Advisory Committees

The International Conference on Harmonisation of Technical Requirements of Registration of Pharmaceuticals for Human Use (ICH)

GCP - Good Clinical Practice, HIPAA

Standard Operating Procedures

New Drug Application (NDA)

Your Role in the Drug Development Process

Test on Section One

MODULE THREE- INITITATING THE STUDY

Selecting Investigators: Is It Really That Important?

Where To Start?

And when?

Your Role

The Investigator's Role

Study Specific Needs

What Specifically Do I Look For In An Investigator?

Medical training

Medical specialty

Ability and experience

Reputation, level or prominence

Required subject population; access to subjects

Geographic concerns, site accessibility

Facilities and equipment

Staff

Concurrent studies

Availability (study start date and duration)

Cost factors, budget

Personal traits

Where Can You Find Investigators?

In-House Network

Professional Network

Literature Review

Directories

Additional Sources

Caution! "Blacklists"

Contacting Potential Investigators

Step 1: Initial Contact

Step 2: Initial Contact Follow-up

Step 3: Checking Out the Site

Evaluation

Prioritize Your List of Candidates

Make the Decision

The Pre-Study Visit

Why Have a Formal Meeting?

When to Visit

To Visit or Not to Visit?

Planning the Visit

First Things First

Estimate How Much Time You Need

Set an Agenda

Contact the Site

Confirm Everything!

At the Site