Assessment of contract research organizations and employees active in the field of clinical research
2018
0 views
0 downloads
Advisor: Prof. Dr. Yeşim Tunçok
Abstract (EN)
Objective: The aim of the study is to determine the qualifications and qualifications of Contractual Research Organizations (CRO) and employees, the name and responsibility of CRO employees and the need to meet the training needs of clinical studies. Method: Information about employees located sake and in Turkey, the number of studies carried out and applying the results of two surveys for determining the field studies were evaluated. The descriptive characteristics of the CRO, the number of clinical trials they conducted and the main study fields, with a total of 8 questions; The descriptive characteristics of CRO employees, their job and job descriptions, working time and training related to clinical research were evaluated with 20 questions. Survey data were recorded in the SPSS 22.0 program. Since the variable distributions are not causal, they are presented with frequency distribution tables. Frequency distributions were used to show the variance between responses to the questionnaires. Findings: One of the CRO's located in Turkey is international, the other seven are local. During 19 years in the study, total number of employees were between 1 and 1500, 7 people surveyed sake. The main workshops were identified as "central organization management". More than half of CRO staff (69.3%) are creative under 35, 40.8%, middle and high school graduates (95.7%), middle and advanced Turkish (88.7%), mostly field coordinators and clinical research specialists. The rate of evaluation of CRO employees by their working time was 28 people (41.2%) who were working for a short period of one year. The executives saw five or more clinical trials and the duration of 35 (51.1%) in the context of the clinical trial. Clinical research related trainings were evaluated and 101.2% were found to have received "Clinical Research Basic Training". Outcome: engaged in clinical research activities in Turkey and that the vast majority of sake participating in the study are only based national structures and institutions. According to their functions, a considerable number of services, such as the ethics committee application, importation of research products, storage and distribution, central management, monitoring, data management and report software, are starting from the project preparation phase. While CRO employees have a high level of education, the vast majority speak English, they have the advantage of being trained in science and health sciences, while overcomplicated workloads, inconsistencies in job descriptions, frequent job changes by employees, and a plethora of clinical workloads per employee are disadvantages. It is a shortcoming for CRO employees to receive training on clinical research from within the institution and not be subjected to a standardized training procedure.
Author
Dr. Güner Yaman
How to Cite
Güner Yaman (Master Thesis). Assessment of contract research organizations and employees active in the field of clinical research, 2018, Dokuz Eylül University.
Keywords
License
Tüm Hakları Saklıdır
This work is shared under the specified license terms.
More theses from Dokuz Eylül University
- AFAD gönüllülük sisteminin etkin müdahale açısından analiz(2020)
- Hittite period ceremonial ceramic vessels and current applications(2023)
- The thoughts and practises of Atatürk's adopted daughter Afet İnan(2018)
- Local dependence measures, properties and applications(2007)
- Jurisprudential sanction and influence of Turkish constitutional courts decisions given as a result of norm controlling(2001)
- The Evaluation of treatment costs of childhood cancers(1997)