Clinical Trial ( GCP) Co-Ordination in Practice Training
OR
Clinical Trial Site Data Capturing (GCP) Practical Training
This course will provide you with a practical background to the understanding of and guidelines in the conduct of clinical trials at your sites. The course is credited by WITS CPD facility.
You will be issued with a Certificate which can be submitted to MCC.
— You will receive all training material and manual
— Refreshments and eats will be served.
— Please complete the registration form and Fax to Karen 0866527852 or e-mail to:
karen@ingonogo.co.za
Form
Course content The course is designed to give theory and practical ideas and an insight to running a study at the site. (Drs rooms or clinic or Hospital setting) it is also practical training for Doctors , Study Co-ordinators with or without experience and Junior CRA’s .
The course will enable you to gain knowledge of good clinical practices, set forth in GCP, according to the local and international regulations.
This is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that data and reporting results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Enable you to run the study efficiently, and effectively, and a system that will work at the site. Enable you to recruit and retain more patients. Run the Site at optimum efficiency
The different levels of the course:
1. Introduction course.
— No Experience
2. Intermediate course
— Basic experience
3. Refresher course
— Experienced
4. A specific trial ( phase 1 / 2/ 3/ 4/ ) set up and training
— This depends on what the site or study design needs are.
Monitoring method
— An attendance register will be signed.
— A certificate of attendance will be issue after completion of the course,
— To pass is 80%.
— The frequency of the course
— Monthly on set dates
— Or — Bookings done on the request
Format of the course. This is lectures with practical demonstrations and which the study co-ordinators or Doctor or pharmacist will also do the practical sessions, with a written test at the end.
— Accreditation
CPD points are allocated on the certificate.
Credited by the WITS CPD Faculty which is through the HPCSA.
The course was also audited by the WITS Ethics committee in Sep 2008.