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Explore the world of clinical data management with the best Clinical Data Management Course Online at Sulekha. Our specialized Clinical Data Management Training with Certification equips freshers and professionals alike with comprehensive knowledge and practical skills essential for excelling in clinical research.
Understanding the Clinical Trial Process
Gain a deep insight into:
• Drug Development Phases: Preclinical trials, clinical trials (Phases I-IV), and post-market surveillance.
• Regulatory Guidelines: Compliance with FDA, EMA, and ICH-GCP standards.
• Clinical Trial Design: Study objectives, endpoints, randomization, and blinding techniques.
Data Collection and Management
Master essential techniques in:
• Data Sources: Identifying and utilizing relevant clinical data.
• Case Report Forms (CRFs): Designing efficient CRFs for accurate data collection.
• Electronic Data Capture (EDC) Systems: Implementing and managing electronic systems effectively.
• Data Validation and Cleaning: Ensuring accuracy through validation techniques and systematic cleaning.
• Data Integrity: Maintaining the reliability and accuracy of data throughout the trial.
Data Analysis and Reporting
Leverage essential tools and practices:
• Statistical Software: Employing software like SAS, SPSS, and R for precise analysis.
• Data Management Plans: Developing comprehensive data handling and analysis protocols.
• Database Lock and Archiving: Finalizing databases securely and archiving data appropriately.
Core Processes & Lifecycle
Dive deep into the comprehensive clinical trial lifecycle:
• Data Management Process: Detailed understanding of data workflows.
• Clinical Trial Phases: Managing data throughout different trial phases.
• Study Setup: Preparing for trial initiation.
• Study Conduct: Efficient trial management and data handling.
• Study Closeout: Closing out trials and managing data effectively.
Understand roles and responsibilities clearly:
• Project Supervisor/Lead Data Manager
• Data Management Assistant
• Database Programmer/Designer
• Medical Coder
• Clinical Data Coordinator
• Quality Control Associate
Essential Skills & Tools
Enhance your skill set:
• Data Validation: Ensuring quality and correctness.
• Edit Checks: Implementing checks for error-free data entry.
• EDC Systems: Proficiency in electronic data capture systems.
• Data Management Plans: Crafting robust and detailed plans.
• Regulatory Guidelines: Compliance with international regulatory standards.
• Communication & Teamwork: Building strong collaboration skills.
Key Activities
Get hands-on training:
• CRF Design: Creating user-friendly and accurate CRFs.
• Database Design: Structuring databases efficiently.
• Data Entry: Accurate and efficient data capturing methods.
• Discrepancy Management: Identifying and resolving data inconsistencies.
• Quality Control: Maintaining high data quality standards.
• SAE Reconciliation: Managing serious adverse event data.
• Data Archiving: Securely archiving data post-trial.
Other Important Concepts
Broaden your knowledge:
• Data Quality Assurance: Ensuring overall data quality.
• Adverse Event Reporting: Accurate and timely reporting processes.
• Patient Recruitment and Retention: Strategies for effective recruitment and retention.
• Emerging Trends: Staying informed about new technologies and methodologies.
Join Sulekha’s Clinical Trial Data Management Training, the best clinical data management course, specially crafted for freshers aspiring to build a rewarding career in clinical research. Start your journey today!
12 to 15 weeks- Based on the mode of learning duration will change
In our clinical data management training, you will learn core concepts like planning, collection, preparation, storage, performance, and reporting clinical trials.
• You will learn to collect and manage data for clinical research studies
• Learn to build an Electronic Data Capture (EDC) instrument using REDCap software
• Understand the entire CDM process from study initiation to database closure for efficient data handling.
• Apply best practices in CDM to ensure consistency and quality throughout the clinical trial.
• Develop a comprehensive data management plan detailing tasks, roles, and protocols.
• Ensure CDM processes comply with FDA and ICH regulations to maintain data integrity.
• Implement key principles to safeguard data security and confidentiality.
• Define deliverables and collaborate effectively with CROs for smooth data management.
Completing the Clinical Data Management course opens up numerous career opportunities in the healthcare and pharmaceutical industries. Potential job roles include:
• Clinical Data Manager
• Clinical Research Associate
• Data Analyst
• SAS Programmer
• Data Coordinator
• Clinical Data Reviewer
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Clinical Research Training Program and placement assistance through online and live Instructor-led classes near you for a bright career as Clinical Research Associate, Clinical Research Coordinator, Clinical Research Manager. Clinical Research course provides in-depth instruction in the skills, methodology, theories, and conceptual framework needed by independent, clinical investigators. Clinical research associates are among the most paid professionals in the job market with a salary of more than $113,814.
“Clinical Data Management Courses – you will learn with hands on practice, in-class seminars, training and certification from the list of World’s finest trainers”. Below listed Education Institutes provides you course materials, tutorial curriculum, demo videos, sample questions, books, tips and tricks. Get ~object.primarytag lectures by experts and practical lessons by instructors to improve your technical skills. Students will benefit with job placements and visa assistance in the United States.
SAS Clinical Training Program and Course is a comprehensive training program designed to equip individuals with the knowledge and skills to analyze and manage clinical data using SAS software. Our Program aims to provide participants with a solid foundation in SAS programming, data manipulation, statistical analysis, and reporting techniques tailored explicitly for clinical trials and research studies.
Our Clinical Data Management (CDM) certification equips professionals with the skills to manage and ensure the integrity of clinical trial data. The program covers essential industry standards like GCP and CDISC, alongside hands-on training in Oracle Clinical and Medidata Rave tools. Participants will gain expertise in data collection, validation, and regulatory compliance with bodies like the FDA and EMA. This certification enhances career opportunities in pharmaceuticals, biotechnology, and healthcare. It prepares individuals to contribute effectively to clinical trials and data-driven healthcare advancements.
Certifications from the Society for Clinical Data Management (SCDM):
Certifications from the Association of Clinical Research Professionals (ACRP):
Clinical Data Interchange Standards Consortium (CDISC) Training:
Certifications from the Regulatory Affairs Professionals Society (RAPS):
Project Management Institute (PMI) Certifications:
Remember that each certification has different requirements for who can get it, such as work experience and education. Reviewing the requirements and choosing the certifications to help you reach your career goals and get the jobs you want is essential.
Our Clinical Data Management course offers an excellent opportunity for aspiring professionals to gain hands-on knowledge and insights into the core principles of clinical data management. The course is designed to cater to the demands of the industry, providing you with the necessary skills to navigate this fast-paced field.
This comprehensive training program encompasses all aspects of Clinical Data Management, taking a deep dive into the world of data quality, validation, cleaning, and database locking. You'll understand the role of Clinical Data Manager and learn the best practices and strategies to excel in this field.
This course is designed to equip you with the necessary skills and knowledge to manage and analyze clinical data effectively. You'll develop a solid understanding of the data management process, ensuring data integrity, and complying with regulatory standards.
This course is suitable for beginners as well as professionals looking to upskill. The course duration is flexible, allowing you to learn at your own pace. While there are no prerequisites, a basic understanding of data analysis will be beneficial. Upon successful completion of the course, you will be awarded a certification in Clinical Data Management.
Our Clinical Data Management Training covers a variety of modules, including:
Take our FREE Skill Assessment Test to discover your strengths and earn a certificate upon completion.
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