Clinical research is an important domain of healthcare sciences. Clinical trials are the main part of clinical research. In clinical trials the safety and effectiveness of new medicines, diagnostic products and medical devices are determined prior to release on the market.
A Clinical Research Associate (CRA) assists in the design, preparation, planning, implementation and review of a clinical trial to ensure it adheres to regulatory and ethical standards. He/she ensures that the reported clinical trial data are accurate, verifiable from source documents and complete and that the clinical study is conducted in accordance with protocol and Good Clinical Practice (GCP). The CRA performs clinical site (hospital) monitoring and manages/ collects clinical research documents, including clinical study protocol, ICFs (Patient Informed Consent Form), CRFs (clinical case report forms), Investigator Brochure and clinical trial related documents.
Patients should be at the heart of healthcare, from prevention and awareness through research and development of new therapies. In clinical development, they are of critical value by providing guidance in the clinical trial design and in the choice of appropriate outcome measures and by validating the feasibility and inclusion speed in patient recruitment. Engaging patients in clinical development process ensures that future therapies reflect real life needs and preferences.
In addition to your training as CRA or as Clinical Study Manager, this 2day programme will learn you more about how biopharmaceutical industry is collaborating with patient organisations in the clinical development of new therapies. From providing input in clinical study design and testing the legibility of informed consent forms to providing valuable guidance in improving patient recruitment and retention. You also will learn more about the role of patient organisations in helping to increase awareness about clinical trials within the community of interested patients. Next to this, you will learn on the recruitment of healthy volunteers for phase 1 clinical trials.
This programme complements your training as CRA and /or Clinical Study Manager and gives you additional knowledge to improve your chances respectively to start as a CRA or to be selected when applying for Clinical Study Manager.
If you cross the border to live, work, study or do business in Belgium, Germany or the Netherlands, you will have to deal with rules and obligations in that country. But it is not always clear what this means for you personally. What should you arrange, what are the consequences of emigration or cross-border work? Border information point provides answers to these and other questions.