How New Drugs are Developed

Overview of Good Clinical Practices (GCP's) under FDA and ICH

• Roles/Responsibilities of the Professionals Directly Involved with Clinical Trials

Starting a Study

• Preparing for the Sponsor's Site Visit
• Dealing with Informed Consents
• Communicating with the Institutional Review Board (IRB)
• Setting up Study Files
• GCP Summary

Coordinating a Study  

Preparing for a Study Initiation Visit

• Recruiting Subjects
• Collecting/Recording Data
• Source Documents
• Case Report Form
• Adverse Experience
• Handling Monitoring Visits
• Managing the Investigative Drug
• GCP Summary

Closing a Study

Workshop Hours—8:30 AM.- 5:00 PM. each day. 

Continental breakfast served at 8:00 AM each day.

Jane Mang, RN, BSN, CCRC

Mary Spadola, RN

The Basics class is designed for new clinical trial coordinators, research nurses or clinical research investigators and for any site professional without previous formal Good Clinical Practice (GCP) training.

Fees

• Regular:  $665
• Early Enrollment:  $565 ($100 Discount) if paid up to 45 days before workshop
• All fees are payable in US Dollars.  Checks only please, payable to CRST. Please send checks to: CRST, 3941 Lankenau Ave., Philadelphia, PA. 19131
• Cancellation fees may apply - see cancellation policy
• Fee includes workshop manual, continental breakfast and two refreshment breaks daily.
• Payment is due no later than two weeks before workshop.

Group Rates

Participants from the same organization who register for the same workshop are eligible for a 10% discount off the regular fee.  There is a 5% discount off the early enrollment fee for group participants.  Group participants must register at the same time to qualify.

Hotel Reservations

• Call the hotel directly and mention the CRST Workshop to receive special rates.
• Rates may only be available up to 30 days prior to the workshop.

Accreditation

•  Workshop completion earns 17 Nursing continuing education contact hours approved by The California Board of Nursing.