1) 加拿大税务局, cCRA certification

2 Weeks
Maximum Allowed Duration: 3 Months
Expected Effort: 12 hours/week

A Clinical Research Associate (加拿大税务局) is a professional who monitors clinical trials and research studies.

Benefits of Certified Clinical Research Associate Training & 认证:

赞助商, 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.

介绍:

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.

Drug Development:

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 (我).

Regulations in Clinical Research:

This module provides training in FDA regulations such as 21 CFR Parts 11, 50, 54, 56, 312,812, 和 814.

Roles & 职责:

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).

必要文件:

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, IND & NDA Requirements and the Clinical Study Report (CSR).

Study Start-Up:

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.

Safety Reporting:

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. 因此, 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 (质量保证) audits and testing, electronic data and signatures, information management and biostatistics..

2) 面向研究者和 CRA 的 GCP 课程

3) 审核员 GCP 课程

(请参阅下文或单击了解详细信息 这里) 

GCP培训课程

(1) GCP培训

ICH-GCP international guidelines

 1: 介绍

1.1 背景

1.2 什么是GCP

1.3 新 GCP 指南

1.4 ICH GCP 原则

1.5 一些一般观点

1.6 文档和版本控制

1.7 质量保证

2: 主管部门 (CA) 和独立道德委员会 (IE)

2.1 Responsibilities of the CA

2.2 Responsibility of the IE

2.3 受试者知情同意书 (ICF)

2.4 作品, 功能, 运营, Procedures and Record

3: Investigat

3.1 研究者的职责

3.2 研究者资格和协议

3.3 充足的资源

3.4 试验对象的医疗保健

3.5 Communication with IRB/IE

3.6 遵守议定书

3.7 Investigational Medicinal Produc

3.8 随机化程序和揭盲

3.9 试验对象知情同意书

3.10 记录和报告

3.11 提前终止或暂停试验

3.12 进度报告和最终报告(s) 由调查人员提供

3.13 归档

3.14 在临床试验管理中使用电子系统的注意事项

3.15 有关电子记录和 EMR 在临床研究中的使用的最新信息.

4: 赞助商的责任

4.1 质量保证和质量控制

4.2 合同研究组织

4.3 试验设计

4.4 试验管理, 数据处理和记录保存

4.5 研究者选择

4.6 融资

4.7 Notification/ Submission to Regulatory Authoritie

4.8 Gaining CA approval in the

4.9 Confirmation of Review by IRB

4.10 即时通讯信息

4.11 制造业, 包装, Labelling and Coding Investigational Product

4.12 Supplying and Handling Investigational Product

4.13 记录访问

4.14 审核与检查

4.15 不合规

4.16 提前终止或暂停试验

4.17 临床试验/研究报告

4.18 多中心试验

5: 监察员的职责

5.1 关于本章

5.2 介绍

5.3 监控

6: 安全 & 不良事件报告

6.1 药品不良反应报告

7: 临床试验方案及修正案

7.1 试验目的和目的

7.2 试验设计

7.3 受试者的选择和撤回

7.4 对象的治疗

7.5 疗效评估

7.6 安全评估

7.7 统计数据

7.8 直接访问源数据/文档

7.9 伦理

7.10 融资与保险

7.11 出版政策

8: 研究者手册

9: 必要文件

9.1 归档

9.2 学习前须提供的文件

9.3 研究期间需添加的文件

9.4 研究后要添加的文件

10  例子

10.1 好的实际例子 (和穷人!) 与进行临床试验相关的实践

I-GCP (E6-R2) 国际准则