Online CRA Training Program

Welcome to the Online CRA Training Program offered by Bangalore Clinical Research Institute (BCRI). Our live online classes are conducted by experienced CRA professionals and are designed to equip you with the necessary skills and knowledge to pursue a successful career in clinical research.

The program is spread over 1.5 months and is offered in weekday and weekend mode. Weekday classes are conducted for 1 hour per day, while weekend classes are conducted for 3 hours per day. The course covers various topics related to clinical research and drug development, as listed below:

Module 1: Introduction to Clinical Research and Drug Development This module provides an overview of the basics of clinical research and drug development. You will learn about the different phases of clinical trials, their objectives, and the key stakeholders involved in the process.

Module 2: Ethics in Drug Development and Regulations in Clinical Research In this module, you will learn about the ethical considerations involved in conducting clinical trials, including patient safety, informed consent, and confidentiality. You will also gain an understanding of the regulatory framework governing clinical research, including the role of regulatory authorities such as the FDA and EMA.

Module 3: Essential Documents and Trial Master File This module covers the essential documents required for clinical trials and their importance. You will learn about the Trial Master File (TMF), its contents, and the importance of maintaining an up-to-date and accurate TMF.

Module 4: Investigator Site Selection and Assessment In this module, you will learn about the process of selecting and assessing investigator sites for clinical trials. You will gain an understanding of the criteria used for site selection and the importance of conducting site assessments to ensure compliance with protocol requirements.

Module 5: Development of Monitoring Plan This module covers the development of a monitoring plan for clinical trials. You will learn about the different types of monitoring, including on-site monitoring and remote monitoring, and the importance of developing a risk-based monitoring plan.

Module 6: Site Initiation, Review of Trial Documents & Delegation of Duties at Individual Site This module covers the process of site initiation, including the review of trial documents and the delegation of duties at individual sites. You will learn about the importance of ensuring that all trial documents are reviewed and approved prior to site initiation and the importance of clearly defining roles and responsibilities.

Module 7: Clinical Trial Monitoring In this module, you will learn about the role of the Clinical Research Associate (CRA) in monitoring clinical trials. You will gain an understanding of the key activities involved in monitoring, including site visits, source document verification, and query resolution.

Module 8: Inventory Planning and Tracking This module covers the planning and tracking of investigational product inventory for clinical trials. You will learn about the importance of accurate inventory management and the key considerations involved in planning and tracking inventory.

Module 9: Source Document Verification (SDV) In this module, you will learn about source document verification (SDV) and its importance in ensuring the accuracy and integrity of trial data. You will gain an understanding of the different types of SDV and the key considerations involved in conducting SDV.

Module 10: CRF Review, Collection & Coordination of Data Management Activities This module covers the review, collection, and coordination of data management activities for clinical trials. You will learn about the importance of ensuring accurate and complete data collection and the key considerations involved in coordinating data management activities across multiple sites.

Module 11: Serious Adverse Event (SAE) Review & Regulatory Compliance In this module, you will learn about the reporting and review of serious adverse events (SAEs) in clinical trials. You will gain an understanding of the regulatory requirements governing SAE reporting and the importance of ensuring compliance with these requirements.

Module 12: Investigational Product (IP) Accountability & Management This module covers the accountability and management of investigational products (IPs) used in clinical trials. You will learn about the importance of accurate and complete IP accountability and the key considerations involved in managing IPs across multiple sites.

Module 13: Site Closure In this module, you will learn about the process of site closure for clinical trials. You will gain an understanding of the key activities involved in site closure, including the collection and management of trial data, the return of investigational products, and the archiving of trial documents.

Module 14: Role of Quality Assurance & Data Management This module covers the role of quality assurance (QA) and data management in clinical trials. You will learn about the importance of ensuring that trial data is accurate, complete, and reliable and the key considerations involved in QA and data management.

At BCRI, we believe that practical training is the key to success in clinical research. Our experienced trainers will provide you with hands-on training and guidance on best practices in the field. By the end of the program, you will have the knowledge and skills necessary to work as a Clinical Research Associate (CRA) and excel in your career.

Join us today and take the first step towards a successful career in clinical research!