1) CRA, certificación cCRA
Maximum Allowed Duration: 3 Months
Expected Effort: 12 hours/week
Un asociado de investigación clínica (CRA) es un profesional que supervisa ensayos clínicos y estudios de investigación.
Beneficios de la formación de asociado certificado en investigación clínica & Certificación:
Patrocinadores, CROs and other agencies involved in the implementation of clinical trials and other forms of medical research are increasingly looking for qualified individuals who have completed formal and approved training and certification in order to be able to rely on them to perform the tasks assigned to them.
CRA Training & Certification Program Structure:
Upon registering for the CRA Training and Certification program, members are granted access to the NBScience learning and certification platform. The online CRA Training & Qualification Program is a 24-hour standardized program that provides core clinical study learning. These are some of the important areas in which training is received after the qualification curriculum has been signed.
This study module, which consists of several lectures and presentations, introduces the participant to the pharmaceutical and clinical research industry.
It also allows for a thorough overview of the clinical research field and the development and developments that have led to the current clinical research environment. The Introductory Module also teaches individuals about clinical research stakeholders and the Principles of Good Clinical Practice (GCP). Technologies in the management of clinical trials are discussed in detail, and comprehensive knowledge of the major clinical research regulatory bodies that exist globally is also provided to individuals.
This program consists of multiple lectures and includes instruction on the pre-clinical development of drugs and biologics, different stages of clinical drug development, design of clinical trials and endpoints in clinical trials.
Ethics in Drug Development:
Each series, consisting of multiple lectures, discusses the concept of ethics in clinical research, the Informed Consent Process, Evidence and HIPAA, and also offers instruction at the International Conference on Harmonization (yo).
Regulations in Clinical Research:
This module provides training in FDA regulations such as 21 CFR Parts 11, 50, 54, 56, 312,812, y 814.
Roles & Responsabilidades:
It is important to identify the roles of all stakeholders in the management of clinical trials so that standards that are realistic can be established. Each section provides a comprehensive overview of the roles of clinical practitioners, sponsors, suppliers and the Institutional Review Boards (IRB).
Essential records are documents which, individually and collectively, make it possible to assess the conduct of the trial and the quality of the data generated. These records provide proof of the investigator’s compliance, support and evaluation with the Good Clinical Practice guidelines and all relevant regulatory requirements.
One of the most important and frequent inspection findings during investigator site inspections is the inadequacy of reliable and accurate source reporting. This is also the most common pitfall found during sponsor audits. To order to ensure that the results of the study are focused on reliable and relevant data, the value of good documentation practice needs to be stressed for the investigator sites. This curriculum focuses on the core principles of good data practice, offers intensive training to key areas such as source documentation, main documents, INDIANA & NDA Requirements and the Clinical Study Report (CSR).
Each section provides an overview of clinical procedures in the start-up phase of a clinical trial. A Study Start-Up Group, vendors and sites identified and activated, procedures established for data collection and reporting, and regulatory approvals obtained shall be established from the final procedure to the first patient visit. The program offers focused instruction in areas such as feasibility evaluation, site selection, pre-study visit, site initiation, recruitment and retention of participants, the TMF (Test Master File) and budgeting of clinical trials.
Study Monitoring & Close Out:
The monitor is responsible for “surveillance the conduct of a research project.” Research monitors must have a thorough understanding of the Code of Federal Regulations, local laws, guidelines and their assigned research protocols. A major part of the reporting duties is to inform and assist sites in compliance with FDA and other local and international regulations and/or recommendations, while also helping them meet the requirements of specific research studies. Monitors act both as communication channels between sites and sponsors and as supervisors for individual research projects. This program offers extensive training in areas such as regular site monitoring, CRF analysis and source data verification, product transparency and compliance, site closure, writing accurate monitoring reports and follow-up visit letters, and record archiving and maintenance.
One of the CRA’s most important priorities is to ensure that clinical inspectors are fully aware of and comply with their responsibility for reporting adverse events. To do it, the CRA must often notify investigators of the criteria for adverse event reporting. Como resultado, the CRA must be aware of both the regulatory and sponsor-specific criteria for reporting significant and non-serious adverse events in clinical trials. It requires the proper use and completion of adverse event forms and criteria and conditions for reporting adverse events that may go further than the regulatory requirements. Each program offers instruction in the identification and monitoring of adverse and serious adverse events in clinical trials.
Role of Quality Assurance & Data Management:
Each program offers relevant training in quality assurance (QA) audits and testing, electronic data and signatures, information management and biostatistics..
2) Curso de GCP para investigadores y CRA
3) Curso de GCP para auditores
(ver abajo o para información detallada haga clic aquí)
Plan de estudios de entrenamiento de GCP
(1) Entrenamiento de GCP
ICH-GCP international guidelines
1.2 ¿Qué es GCP?
1.3 Nueva guía de GCP
1.4 Los principios de ICH GCP
1.5 Some General Point
1.6 Documentación y control de versiones
1.7 Seguro de calidad
2: Las autoridades competentes (ESE) y comité de ética independiente (IE)
2.1 Responsibilities of the CUNA
2.2 Responsibility of the IE
2.3 Asunto Formularios de consentimiento informado (ICF)
2.4 Composición, Las funciones, Operaciones, Procedures and Record
3.1 Responsabilidades del investigador
3.2 Calificaciones y acuerdos del investigador
3.3 Adequate Resource
3.4 Atención médica de sujetos de prueba
3.5 Communication with IRB/IE
3.6 Cumplimiento del protocolo
3.7 Investigational Medicinal Produc
3.8 Procedimientos de aleatorización y desenmascaramiento
3.9 Informed Consent of Trial Subject
3.10 Records and Reports
3.11 Terminación prematura o suspensión de un juicio
3.12 Informes de progreso e informe final(s) by Investigators
3.14 Consideraciones para el uso de sistemas electrónicos en la gestión de ensayos clínicos.
3.15 Updated information on electronic records and use of EMRs in clinical research.
4: Responsabilidades del patrocinador
4.1 Garantía de calidad y control de calidad
4.2 Contract Research Organization
4.3 Diseño de prueba
4.4 Gestión de prueba, Manejo de datos y mantenimiento de registros
4.5 Selección de investigador
4.7 Notification/ Submission to Regulatory Authoritie
4.8 Gaining CA approval in the
4.9 Confirmation of Review by IRB
4.10 Information on IM
4.11 Fabricación, embalaje, Labelling and Coding Investigational Product
4.12 Supplying and Handling Investigational Product
4.13 Acceso de registro
4.14 Auditoria e Inspeccion
4.16 Terminación prematura o suspensión de un juicio
4.17 Clinical Trial/Study Report
4.18 Multicentre Trial
5: Responsabilidades del monitor
5.1 Sobre este capitulo
6: La seguridad & Informe de eventos adversos
6.1 Informe de reacciones adversas a medicamentos
7: Clinical Trial Protocol and Amendment
7.1 Objetivos de prueba y propósito
7.2 Diseño de prueba
7.3 Selection and Withdrawal of Subject
7.4 Treatment of Subject
7.5 Evaluación de eficacia
7.6 Evaluación de seguridad
7.8 Acceso directo a los datos / documentos de origen
7.10 Financiamiento y Seguros
7.11 Política de publicación
8: Folleto del investigador
9: Documentos esenciales
9.2 Documentos para estar presente Pre-estudio
9.3 Documentos que se agregarán durante el estudio
9.4 Documentos que se agregarán después del estudio
10.1 Ejemplos prácticos de bien (y pobre!) practice in relation to conducting clinical trial
ICH-GCP (E6-R2) pautas internacionales