Clinical research is conducted to advance human medicine by developing efficacious treatments and improving patient outcomes when new therapies are developed and implemented. Clinical trials are a subset of the types of clinical research conducted on human volunteers in the development of new drugs, devices and other therapies. Prior to the start of a trial, a country’s regulatory authority must review the trial to ensure it is scientifically and ethically sound. In Canada, the regulatory authority is Health Canada. The International Conference on Harmonization (ICH) of technical requirements for the registration of pharmaceutics for humans aims to provide ethical and scientific quality standards for design, conduct, data collection and reporting in clinical trials. The Good Clinical Practice (GCP) Guidelines were created by the ICH Steering Committee to assure the public that rights, safety and well being of subjects are protected according to the Declaration of Helsinki, and the clinical data obtained in a ICH/GCP compliant clinical trial will meet regulatory requirements. Health Canada has adopted the ICH/GCP Guidelines and therefore, in Canada, all clinical trials involving humans must comply with these Guidelines. The clinical trial coordinator is an important and central position on the research team executing many trial duties and communications. Regulatory authorities, Research Ethics Boards and the sponsor, overlook the role and responsibilities of a highly trained clinical coordinator, despite their vital and central position. The GCP Guidelines also fail to address the role and responsibilities of a clinical coordinator. Disconnect between guidelines, regulatory expectations and actual trial conduct provides an apparent need to formalize and clearly define the role and scope of a clinical coordinator. The Registered Nurse (RN) brings professionalism, knowledge, skill and a holistic perspective to the expanded role of a clinical coordinator and to the clinical trial. Highly trained health professionals are capable of assuming more responsibilities and executing clinical trial design, setup and management as compared to the traditional administrative roles of the clinical coordinator. The expanded role of the clinical coordinator is especially beneficial for Principal Investigator initiated trials due to limited research personnel and resources. Postoperative adhesions are a common complication following pelvic surgery, therefore, this clinical trial is relevant and a response to a healthcare need. My graduate studies focused on the development and set up of the clinical trial Protocol ADE002-2013 Phase I Trial of L-Alanyl-L-Glutamine for the Reduction of Peritoneal Adhesions in Adult Females Undergoing Myomectomy. My thesis is a discussion of general Canadian clinical trial research information followed by an explanation of how we executed the information to design and set up our PI initiated clinical trial. The value of the expanded role of the clinical coordinator as a member of the research team will also be discussed.

Introdução: Os estudos clínicos promovem inovação no âmbito da saúde e podem proporcionar novos tratamentos e benefícios à população. Os estudos de intervenção com medicamentos são fundamentais para demonstrar a eficácia, a toxicidade e a segurança de novas terapias. O uso de medicamentos experimentais na assistência médica é uma realidade observada tanto na continuidade do tratamento pelos participantes após o término da pesquisa, como na possibilidade do uso assistencial destes medicamentos. A Agência Nacional de Vigilância Sanitária (Anvisa) regulamenta, com base na RDC n. 38/2013, três Programas assistenciais com medicamentos experimentais: Acesso Expandido, Uso Compassivo e Fornecimento de Medicamento Pós-Estudo. Mais recentemente, uma nova alternativa está em desenvolvimento no Hospital de Clínicas de Porto Alegre, definida como Uso Assistencial Extraordinário. Objetivos: Propor fluxos e materiais informativos para orientar a prática e a condução de Programas de Acesso Expandido, Uso Compassivo, Fornecimento de Medicamento Pós-Estudo e Uso Assistencial Extraordinário no Hospital de Clínicas de Porto Alegre, assim como em outras instituições de saúde. Métodos: Foram revisadas as publicações acerca do assunto, analisados alguns fluxogramas existentes na condução dos Programas acima citados, bem como realizado questionário aos profissionais que atuam nesta área no CPC-HCPA. Resultados: Foram elaborados fluxos e materiais informativos para a condução destes distintos Programas, considerando as diretrizes éticas, regulatórias e de boas práticas, que visam auxiliar a prática e a educação dos profissionais envolvidos. / Introduction: Clinical research can provide valuable evidence to support to health care system in informed decision making. At the same time, from the patient perspective, trials can the way to gain access to more appropriate treatments. The main goal of intervention studies is to determine safety and efficacy of new therapies. The Agência Nacional de Vigilância Sanitária (Anvisa) regulates, based on RDC n° 38/2013, three care programs with experimental drugs: Expanded Access, Compassionate Use and Post-trial Access. Also, in the Hospital de Clínicas de Porto Alegre, a new alternative program is being explored - defined as Extraordinary Care Use. Objectives: Propose guidelines to Expanded Access, Compassionate Use, Post-trial Access programs and Extraordinary Care Use in the format of flow sheets and informative leaflets at Hospital de Clínicas de Porto Alegre, and perhaps become a benchmarking project to other institutions. Methods: After review of literature and analysis of existing flow sheets on how to conduct the above mentioned programs, we administered a survey questionnaire on challenges encountered by investigators from clinical research center at our institution. Results: Flow sheets and informative materials were developed to support professionals their research groups in conducting clinical interventional initiatives, considering the ethical, regulatory and good practices guidelines.

Introdução: Os estudos clínicos promovem inovação no âmbito da saúde e podem proporcionar novos tratamentos e benefícios à população. Os estudos de intervenção com medicamentos são fundamentais para demonstrar a eficácia, a toxicidade e a segurança de novas terapias. O uso de medicamentos experimentais na assistência médica é uma realidade observada tanto na continuidade do tratamento pelos participantes após o término da pesquisa, como na possibilidade do uso assistencial destes medicamentos. A Agência Nacional de Vigilância Sanitária (Anvisa) regulamenta, com base na RDC n. 38/2013, três Programas assistenciais com medicamentos experimentais: Acesso Expandido, Uso Compassivo e Fornecimento de Medicamento Pós-Estudo. Mais recentemente, uma nova alternativa está em desenvolvimento no Hospital de Clínicas de Porto Alegre, definida como Uso Assistencial Extraordinário. Objetivos: Propor fluxos e materiais informativos para orientar a prática e a condução de Programas de Acesso Expandido, Uso Compassivo, Fornecimento de Medicamento Pós-Estudo e Uso Assistencial Extraordinário no Hospital de Clínicas de Porto Alegre, assim como em outras instituições de saúde. Métodos: Foram revisadas as publicações acerca do assunto, analisados alguns fluxogramas existentes na condução dos Programas acima citados, bem como realizado questionário aos profissionais que atuam nesta área no CPC-HCPA. Resultados: Foram elaborados fluxos e materiais informativos para a condução destes distintos Programas, considerando as diretrizes éticas, regulatórias e de boas práticas, que visam auxiliar a prática e a educação dos profissionais envolvidos. / Introduction: Clinical research can provide valuable evidence to support to health care system in informed decision making. At the same time, from the patient perspective, trials can the way to gain access to more appropriate treatments. The main goal of intervention studies is to determine safety and efficacy of new therapies. The Agência Nacional de Vigilância Sanitária (Anvisa) regulates, based on RDC n° 38/2013, three care programs with experimental drugs: Expanded Access, Compassionate Use and Post-trial Access. Also, in the Hospital de Clínicas de Porto Alegre, a new alternative program is being explored - defined as Extraordinary Care Use. Objectives: Propose guidelines to Expanded Access, Compassionate Use, Post-trial Access programs and Extraordinary Care Use in the format of flow sheets and informative leaflets at Hospital de Clínicas de Porto Alegre, and perhaps become a benchmarking project to other institutions. Methods: After review of literature and analysis of existing flow sheets on how to conduct the above mentioned programs, we administered a survey questionnaire on challenges encountered by investigators from clinical research center at our institution. Results: Flow sheets and informative materials were developed to support professionals their research groups in conducting clinical interventional initiatives, considering the ethical, regulatory and good practices guidelines.

Introdução: Os estudos clínicos promovem inovação no âmbito da saúde e podem proporcionar novos tratamentos e benefícios à população. Os estudos de intervenção com medicamentos são fundamentais para demonstrar a eficácia, a toxicidade e a segurança de novas terapias. O uso de medicamentos experimentais na assistência médica é uma realidade observada tanto na continuidade do tratamento pelos participantes após o término da pesquisa, como na possibilidade do uso assistencial destes medicamentos. A Agência Nacional de Vigilância Sanitária (Anvisa) regulamenta, com base na RDC n. 38/2013, três Programas assistenciais com medicamentos experimentais: Acesso Expandido, Uso Compassivo e Fornecimento de Medicamento Pós-Estudo. Mais recentemente, uma nova alternativa está em desenvolvimento no Hospital de Clínicas de Porto Alegre, definida como Uso Assistencial Extraordinário. Objetivos: Propor fluxos e materiais informativos para orientar a prática e a condução de Programas de Acesso Expandido, Uso Compassivo, Fornecimento de Medicamento Pós-Estudo e Uso Assistencial Extraordinário no Hospital de Clínicas de Porto Alegre, assim como em outras instituições de saúde. Métodos: Foram revisadas as publicações acerca do assunto, analisados alguns fluxogramas existentes na condução dos Programas acima citados, bem como realizado questionário aos profissionais que atuam nesta área no CPC-HCPA. Resultados: Foram elaborados fluxos e materiais informativos para a condução destes distintos Programas, considerando as diretrizes éticas, regulatórias e de boas práticas, que visam auxiliar a prática e a educação dos profissionais envolvidos. / Introduction: Clinical research can provide valuable evidence to support to health care system in informed decision making. At the same time, from the patient perspective, trials can the way to gain access to more appropriate treatments. The main goal of intervention studies is to determine safety and efficacy of new therapies. The Agência Nacional de Vigilância Sanitária (Anvisa) regulates, based on RDC n° 38/2013, three care programs with experimental drugs: Expanded Access, Compassionate Use and Post-trial Access. Also, in the Hospital de Clínicas de Porto Alegre, a new alternative program is being explored - defined as Extraordinary Care Use. Objectives: Propose guidelines to Expanded Access, Compassionate Use, Post-trial Access programs and Extraordinary Care Use in the format of flow sheets and informative leaflets at Hospital de Clínicas de Porto Alegre, and perhaps become a benchmarking project to other institutions. Methods: After review of literature and analysis of existing flow sheets on how to conduct the above mentioned programs, we administered a survey questionnaire on challenges encountered by investigators from clinical research center at our institution. Results: Flow sheets and informative materials were developed to support professionals their research groups in conducting clinical interventional initiatives, considering the ethical, regulatory and good practices guidelines.

The subject of my dissertation is fraud in clinical trials in terms of ethics and law. The aim of my research was to analyze the frequency of fraud in clinical trials of a given sample of data collected, identify the main fraudsters and to analyze the causes that led participants in clinical trials to commit fraud. In the theoretical part of my dissertation I defined the concepts of clinical trials, deception, ethical issues and the relevant legal framework. The practical part contains the results of the data analysis of the incidence and causes of fraud, the main actors of fraud and conception of recommendations, which appears to be essential for the prevention of fraud in clinical trials. The data analysis and participant observation show that during 107 GCP (Good Glinical Practice) audits conducted during the period of 2008-2013 in 22 countries, 14 revelations of fraud in clinical trials were identified, which represents 13.1 %. Most often fraud was committed by investigators, a total of 47.6 % of all observed groups of cheating clinical trial participants. The main causes that led investigators to commit fraud represent a lack of eligible patients, financial gain and personality traits. Based on the results obtained during my research I highlighted in the practical part of my dissertation the ethical...

The subject of my dissertation is fraud in clinical trials in terms of ethics and law. The aim of my research was to analyze the frequency of fraud in clinical trials of a given sample of data collected, identify the main fraudsters and to analyze the causes that led participants in clinical trials to commit fraud. In the theoretical part of my dissertation I defined the concepts of clinical trials, deception, ethical issues and the relevant legal framework. The practical part contains the results of the data analysis of the incidence and causes of fraud, the main actors of fraud and conception of recommendations, which appears to be essential for the prevention of fraud in clinical trials. The data analysis and participant observation show that during 107 GCP (Good Glinical Practice) audits conducted during the period of 2008-2013 in 22 countries, 14 revelations of fraud in clinical trials were identified, which represents 13.1 %. Most often fraud was committed by investigators, a total of 47.6 % of all observed groups of cheating clinical trial participants. The main causes that led investigators to commit fraud represent a lack of eligible patients, financial gain and personality traits. Based on the results obtained during my research I highlighted in the practical part of my dissertation the ethical...