SAS Clinical
Course Overview
Course Curriculum
Week-1: Foundations of Clinical Domain and SAS Programming
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Overview of Clinical Domain: Understanding the significance of clinical research in healthcare and pharmaceutical industries.
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Clinical Trial Phases: Exploring the sequential stages of clinical trials, from initial testing to post-market surveillance.
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Clinical Trial Designs: Delving into various methodologies employed in clinical research, such as randomized controlled trials and cross-over trials.
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Regulatory Guidelines: Getting acquainted with regulatory standards set by bodies like the International Council for Harmonisation (ICH)and the importance of adherence to Good Clinical Practice (GCP) guidelines.
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Study Documentation: An introduction to essential documents like annotated Case Report Forms (aCRF), Protocols, Statistical Analysis Plans (SAP), and Specifications.
Week-2: CDISC Standards and Safety Domains
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CDISC Standards Introduction: Understanding the Clinical Data Interchange Standards Consortium (CDISC) and its significance in data standardization.
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SDTM (Study Data Tabulation Model): Learning the structure and classification of SDTM domains, with a focus on safety domains.
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Safety Domains: Understanding the intricacies of safety-related data domains and their importance in clinical research.
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Specification Development: Hands-on experience in developing specifications for safety model domains.
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Project Work: Engaging in a case study to apply knowledge in real-world scenarios, including working with Demographics, Adverse Events, Concomitant Medication, and Vital Signs data.
Week-3: ADAM Model Implementation and Dataset Development
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Introduction to ADAM: Understanding the purpose and structure of the Analysis Data Model.
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ADAM Model Domains: Implementing ADAM model domains, including ADSL (Analysis Data Specification) domain.
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Assignment and Project Work: Engaging in hands-on assignments focusing on ADSL specification and dataset development.
Week-4: Advanced ADAM Implementation and Dataset Development
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Advanced ADAM Overview: Delving deeper into the intricacies of ADAM model domains.
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Implementation of Additional Domains: Hands-on practice in implementing ADVS, ADCM, and ADAE domains.
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Assignment Work: Undertaking assignments focused on ADVS, ADCM, and ADAE dataset development.
Week-5: Report Generation and TLFs Development
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Overview of SDTM & ADAM: Understanding the relationship between SDTM and ADAM and their role in report generation.
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Report Generation: Learning to generate summary tables, adverse event listings, and develop figures.
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Assignments: Hands-on assignments to practice TLF development using clinical data.
Week-6: Review, Discussion, and Mock Interviews
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Assignment Review: Reviewing and discussing assignments from previous weeks.
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Group Discussion: Engaging in discussions on various aspects of clinical SAS programming.
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Interview Preparation: Preparing for technical and domain-specific interview questions.
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Mock Interviews: Participating in mock interviews to simulate real-world interview scenarios and receive feedback.
About This Course:
- Free IT Training
- Free Certification
- Free Interview Support
- Free Project Support
- Contact & Address
$1,000.00
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