The Nuts and Bolts of putting a research study into operation: A Workshop for Research Professionals

November 16, 2015

Services

Who is this course aimed at?
Study coordinators, researchers, investigators, project managers or any person in the research team who have a clinical study or trial to implement and who need help in the practical steps to get it done.

This intensive 2 and half day course covers important aspects of implementing a study as well as quality management.

What will be covered?

  • The life cycle of a research project
  • External and Internal Role Players in clinical research
  • Preparing submissions for ethics and other approvals
  • Putting together a research team
  • Developing systems and SOPs
  • Designing your tools for optimal quality and efficiency : the informed consent, source documents, CRFs and other documents
  • Good Documentation Practice and ALCOA C
  • Recruitment and Retention Plans
  • The philosophy, regulatory framework and application of quality management in clinical research
  • The difference between quality control, quality assurance and quality management
  • Developing, writing and implementing a clinical quality management plan (CQMP)
  • Understanding and writing Corrective action, Preventative action (CAPA) plans/reports
  • Operational metrics: what to measure and how
  • Keeping your data clean and manageable and your research ethical and sound

To get the most out of this course, we highly recommend that participants have attended a prior GCP course.

The topics above are only to provide a solid structure to the course. We have designed the course in such a way that it is dynamic and fluid and completely adaptable to the needs of the group on the day of presentation. We invite you to bring your questions, challenges and case-scenarios along.

What is the focus of the course?

The focus is on applying GCP principles in the field, on the translation of policies and guidelines into practical steps, and a pragmatic methodical integrated approach. This course is not about study design or the science per se, but about application.

What is the format of the course?

The course is interactive, in a small group workshop environment. Participants are encouraged to come with questions and ideas. Real-life research proposals that can be worked on during the workshop are useful, but not essential.

Who are the facilitators?

CREDE is known for its customized and interactive courses in, amongst others, GCP, GDP and consultancy work with clinical research sites. The facilitators have ground-level experience combined with in-depth knowledge and are proficient in this style of training.

What about cost and logistics?

The course is run over two and a half days. Lunch and tea are included. All course material will be provided.

CPD points and a certificate of attendance will be issued (useful for CVs).
Cost: R 5300.00 + R795.00(VAT) = R6 095.00
For further information and to book your place contact Rhonda at admin@crede.co.za
Tel: 060 955 0417