GCP Refresher for Study Nurses

Update your knowledge on innovations and developments in clinical trials 2 years after your last Study Nurse training.

Study Nurse Studienkoordinatorin Refresher

GCP Refresher for Study Nurses

Aim

Professional and well-trained study teams are necessary to ensure that clinical trials are carried out in accordance with national and international guidelines. Study Nurses, in particular, play a central role in guaranteeing compliance. As the primary contact for patients, Investigators and Clinical Monitors Study Nurses ensure that everything runs smoothly at the site, look after subjects, collect and record relevant study data and prepare for monitoring visits and audits. This practical course brings your knowledge and skills up-to-date, and enables you to work independently and play a more responsible role in the conduct of clinical trials.

On completion of the seminar you will receive a certificate that is recognized within the clinical research industry. There is no end of course examination.

The German Association for Study Nurses and Study Coordinators (BUVEBA) was founded in 2011 in order to define the training requirements and qualifications for Study Nurses nationwide. Every year the Association hosts the Federal Congress for Study Nurses to link its members and to discuss current topics within the profession. You can find more information about the Association and its activities at BUVEBA.de.

Participants
  • Study Nurses
  • Study Coordinators
  • Study Assistants

Anyone working in this function at a site, who would like to refresh, update or deepen their knowledge of clinical trials.

Requirements

More than two years since last Study Nurse training

Benefits

On completion of this seminar you will have in-depth understanding of national and international regulations in the field of clinical research. You will have a broader knowledge of aspects of clinical trial conduct such as drug accountability, recording source data, informed consent, adverse events, audits and inspections.

The extensive use of realistic case studies and practical exercises ensure effective learning, and make it easy for you to apply what you have learned to your working.

Program overview

The Study Nurse Refresher course consists of 8 lessons (45 minutes).

The seminar makes extensive use of practical exercises and case studies, and provides you with an immediate opportunity to apply your knowledge.

THEORY

  • Ethical principles and international guidelines
  • Medical records, CRFs, source data verification
  • Study medication and drug accountability
  • Informed consent
  • Adverse Events
  • Audits and Inspections

PRACTICAL EXERCISES AND EXAMPLES

  • Study medication and drug accountability
  • Source data and source data verification
  • Patient Information

Next program start

03.04.2019
One-day event
Register