Basic Course in Clinical Research - 20 March 2019

Who should attend?

This course is designed for those with little or no experience in clinical research or those seeking an overview of the clinical research process, regulations, terminology, acronyms, roles and responsibilities within clinical research. It is aimed at Clinical Research Assistants, support staff and persons with related functions (eg. IT Support Staff).

Course Objectives

The course offers a general overview of the drug development process and most relevant tasks and responsibilities within the clinical research setting, focusing on practical aspects and mainly addressing the needs of assistants and support personnel.

With this course you will

• Understand how drugs are developed and who the key players are in the process
• Become knowledgeable about the terminology used in the clinical research environment
• Find out what rules, guidelines and laws are essential
• Learn how a clinical study is set up and performed
• Become familiar with and understand how to handle the documentation required in clinical research

Topics

• Developing a drug in the pharmaceutical industry – from the idea to the product you buy in the pharmacy – and the contributions of clinical research
• What is a clinical study – the four phases of clinical development
• Who are the key players and what are their roles in the process
• The language and abbreviations the clinical research team are using every day
• What are the rules, guidelines and laws that need to be followed and why are they so important
• How is a clinical study performed – from preparation over conduct to termination of a study
• A key to a successful study: the master study file. What documents are essential and how are they handled, filed and archived?
• What is the job description and what is the role of a clinical research assistant?

Course Leader

Tamara Schärer, (MSc, ECPM), Managing Director, SRS Schärer Research Services, Basel, Switzerland. Ms Schärer started working in the pharmaceutical industry as a Clinical Research Scientist in the field of CNS for SAndoz in 1996. After the merger to Novartis, she became the Therapeutic Area Coordinator for all Phase IV studies in Oncology. IN 1999 Tamara moved to a small CRO as an International Project Manager and later trained as a GCP Auditor to become Quality Manager Clinical Operations. In 2002, she founded SRS Schärer Research Services.

Learning Methodology

Interactive sessions with a mix of lecture, case studies to illustrate theory, exercises to test the knowledge and Q&A.

Date:

20 March 2019

Time:

09.00 – 17.00 hrs

Venue:

CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Directions:

Tram 15
Tram stop «Grosspeterstrasse»

Fee:

Early Bird Fee: CHF 855.00 + 7.7% VAT (valid until: 07.02.2019)
Regular Fee: CHF 950.00 + 7.7% VAT (valid after: 07.02.2019)
10 % reduction for CTC employees and SwAPP members.
The fee includes course documentation, refreshments, lunch and a course participation certificate.
Payment: After registration you will receive confirmation and an invoice with instructions on how to complete the bank transfer. Full prepayment is needed prior to the course.

Cancellation Policy:

• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund
In case of no show, no refund will be made.

Document:

Basic in CR_Flyer.pdf

Training Terms & Conditions