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
Evaluate the Facilities
Meet with the Investigator
Meet with the Staff
Simulation: Informed Consent Form review and critique
Pre-Study Visit Report and Follow-up
Site Selection
Next Steps
Simulation: IRB Approval Letter Review and critique
The Study Initiation Visit
Why Have a Formal Visit?
Before the Visit
When to Visit
Planning Your Visit
Estimate How Much Time You Need
Set an Agenda
Contact the Site
Confirm Everything!
Gather Meeting Materials
Private Meeting with the Investigator
The Group Meeting
Protocol Review
Study Drug Administration
Assessment
Laboratory Procedures
Adverse Events
Recruitment
Inclusion/Exclusion Criteria
Informed Consent Instructions
Enrollment
Withdrawals
Handling Objections to the Protocol
Case Report Form Review
Reviewing the Form
Corrections
Common Errors
Managing clinical supplies
Receiving
Storing
Dispensing
Ordering
Return
Other Study Obligations
Monitoring Visits and Audits
Investigator's Essential Document File
Record Retention
Contact
Final Meeting with the Investigator
Documentation and follow up
MODULE THREE EXAM
MODULE FOUR - MONITORING THE STUDY
Monitoring
Types of Monitoring Visits
Frequency of Monitoring Visits
PREPARING FOR THE MONITORING VISIT
Conducting the Monitoring visit
Initial Monitoring Visit Tasks
Monitoring Study Progress
Medication Inventory and Accountability
Simulation: Performing Drug Accountability
Reviewing CRFs
Simulation: Case Report Form Review & Protocol Compliance
Simulation: Source Document Verification
Adverse Event Classification & Reporting
Collecting Paper CRFs
A Final Word - Be Efficient
Between Monitoring Visits
sAfter The Monitoring Visit
Monitoring Visit Report
Documenting Telephone Conversations
Follow Up
MODULE FOUR EXAM
MODULE FIVE - CLOSING THE STUDY
Study Closeout Visit
When to Visit
Prepare for the Visit In-House
Contact the Investigator
At the Site
Reconcile Clinical Supplies
Finalize all Data Issues
Investigator's Essential Document File
Prepare the Site for an Audit
Final Meeting with the Investigator
Documentation and Follow Up
Closing Out a Single Site
MODULE FIVE EXAM
COURSE MASTERY EXAMINATION (FINAL EXAM)
