Internship report in clinical studies coordination at IPO-Porto

• Autor(a) principal: Correia, Márcia Sofia Barbosa
• Data de Publicação: 2014
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10773/12949
• topic: Biomedicina; Ensaios clínicos; Oncologia

This report describes my activities as study coordinator (SC) intern, at the “Unidade de Investigação Clínica” (UIC) in the Oncology Portuguese Institute of Porto (IPOP). This training occurred during the second year of the Pharmaceutical Biomedicine Master at the University of Aveiro. My internship took place between 21st January, 2013 and 4th October, 2013 with the main objective to gain experience and expertise in oncology coordinating clinical trials. I present the state-of-the-art of clinical research with emphasis on current situation in Portugal as well as in oncology. At the beginning of internship I performed generic training in Good Clinical Practices (GCP) and Electronic Data Capture systems and familiarised myself with terminology and classification/assessment systems regarding the oncology area to support the clinical trial coordination activities in the context of the oncology protocols. In UIC, I participated in 6 phase II and 25 phase III clinical trials of 9 clinics of pathology: Urology, Gynaecology, Digestive, Lung, Soft Tissue and Skin, Head and Neck, Onco-Haematology, Breast and Paediatry. Within of these clinics, I intensively participated and acquired more autonomy in clinical trials of the Digestive pathology. The Onco-Haematology clinic includes the more complex procedures of the clinical trials protocols. As SC, I could intensively participate in the conduction clinical trial activities, namely: Randomisation Period, including Screening and Randomisation of patients, Clinic Visits and Monitoring Visits. The experience gained during my curricular internship was very enriching and enabled me to acquire professional and interpersonal skills and competences and to face unexpected situations, developing strategies to deal with them. Additionally, it was possible to consolidate and apply the theoretical knowledge acquired during Master Course in Pharmaceutical Medicine at different stages of clinical trials coordination. In conclusion, during my curricular internship, I gathered the competences, motivation and experience to pursue a career in clinical research, particularly, as SC.