The nuts and bolts of putting a research study into operation: a workshop for Study Coordinators and Investigators

November 16, 2015


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
  • 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.

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 is included.

Participants have the option of combining this course with the Participant Safety Management Module on the afternoon of the third day.

 CPD points and a certificate of attendance will be issued (useful for CVs).
Cost: R 4945.00 

For further information and to book your place (limited spots available!) contact Marijke or Hennie Geldenhuys (,, tel 0832853473.