Making clinical research crystal clear
KL-CR01: Clinical Research Basics
This course covers the fundamental principles of clinical research for beginners or professionals seeking to enhance their knowledge on the topic.
KL-MW01: Regulatory Medical Writing
A comprehensive course on regulatory medical writing covering regulatory guidelines and standards as well as the best practices for effective writing.
KL-MW02: Medical Communication
A medical communication course focused on the strategies and skills needed to effectively convey medical information to diverse audiences.
KL-MW03: Clinical Trial Transparency
The perfect course for anyone who wants to gain a deep understanding of the complex and ever-changing world of clinical trial transparency.
KL-CR01: Clinical Research Basics
The course is designed for beginners who are interested in pursuing a career in clinical research or for professionals seeking to enhance their knowledge in this field. It provides an in-depth introduction to the fundamental principles of clinical research and covers the entire process from study design to regulatory and ethical considerations.
Course Duration:Individual participants can select either of the two models below
- Mentor-led (12 hours, to be covered over 6 weeks)
- Self-paced (Access to course material for 3 months)
Upon completion of this course, participants will be able to:
- Understand the basic concepts and terminology of clinical research
- Evaluate different clinical trial designs
- Navigate the regulatory and ethical landscape of clinical research
- Communicate clinical research findings effectively with different stakeholders
Module 1: Basics of Clinical Research (4 h)
- History and Evolution of Clinical Research
- Different Phases of Clinical Research
- Clinical Research Ethics
- Clinical Research Design
- Good Clinical Practices
- Institutional Review Boards/Ethics Committees
- Clinical Trial Monitoring and Quality Assurance
- Adverse Event Reporting and Management
- Overview of Regulatory Authorities (FDA, EMA, CDSCO) and ICH Guidelines
- Communication with Regulatory Agencies, Sponsors, Investigators, and Participants
- Overview of submission documents
KL-MW01: Regulatory Medical Writing
This comprehensive course on regulatory medical writing is designed to equip participants with the knowledge and skills to create high-quality documents that comply with relevant regulatory guidelines and standards. In this course, participants will learn about the types of regulatory documents, the processes involved in their creation, and best practices for effective writing.
This course is ideal for aspiring medical writers, regulatory affairs professionals, and anyone interested in the regulatory aspects of medical writing.
Individual participants can select either of the two models below.
- Mentor-led (18 hours, to be covered over 12 weeks)
- Self-paced (Access to course material for 6 months)
Upon completion of this course, participants will be able to:
- Understand the role and importance of regulatory medical writing in the pharmaceutical industry
- Identify and describe the different types of regulatory documents
- Apply regulatory guidelines and standards in the creation of documents
- Develop skills in writing clear, concise, and accurate regulatory documents
- Collaborate effectively with cross-functional teams in the preparation of regulatory submissions
Module 1: Introduction to Regulatory Medical Writing (2 h)
- Introduction and scope of regulatory medical writing
- Overview of regulatory authorities and processes (FDA, EMA, CDSCO)
- Types of regulatory documents
- ICH E6: Good Clinical Practices
- ICH E3: Clinical Study Reports
- ICH M4E and M4S: Efficacy and Safety Summaries
- Writing a Protocol and its Amendments
- Writing an Informed Consent Document (ICD)
- Best Practices in Protocol and ICD Writing
- Writing an IB
- Updating an IB
- Best Practices in Writing and Updating an IB
- Types of CSRs
- Structure of a Full CSR
- Writing Standalone and In-text Narratives
- Presentation of Data – Tables and Figures
- Best Practices in CSR Writing
- Overview of the CTD structure (Modules 1-5)
- Writing Non-clinical Summaries and Overview
- Writing Clinical Summaries and Overview
- Differences Between Regional Requirements
- Best Practices in Preparing a Coherent CTD Dossier
- Peer Review and Quality Control
- Proofreading Techniques
- Responses to Reviewers’ Comments and Revisions
- Ensuring Compliance with Regulatory Requirement
- Working in a Cross-functional Team
- Communication with Stakeholders
- Conflict Resolution and Negotiations
- Timeline Management
KL-MW02: Medical Communication
This course offers a comprehensive introduction to medical communications, focusing on the strategies and skills needed to effectively convey medical information to diverse audiences. Participants will learn to create clear, accurate, and impactful medical content for different purposes and formats, including scientific publications, educational materials, promotional content, and patient communications. This course is ideal for medical writers, healthcare professionals, and anyone interested in the field of medical communications.
Course DurationIndividual participants can select either of the two models below
- Mentor-led (14 hours, to be covered over 8 weeks)
- Self-paced (Access to course material for 4 months)
Upon completion of this course, participants will be able to:
- Understand the key principles of medical communications
- Create and edit high-quality medical content for various audiences and formats
- Apply ethical standards and regulatory guidelines in medical communications
- Develop effective communication strategies for scientific, educational, promotional, and patient-centred content
- Utilize various tools and techniques to enhance the clarity and impact of medical communications
Module 1: Introduction to Medical Communications (2 h)
- Scope of Medical Communications
- Importance of Effective Medical Communications
- Types of Medical Communications (Scientific, Educational, Promotional, Patient-centred)
- Medical Communications with Different Stakeholders (Healthcare Professionals, Patients, Regulatory Authorities)
- Publication Ethics
- Structure of a Scientific Manuscript
- Selecting Journals for a Manuscript
- Writing Abstracts and Titles
- Literature Review and Organising Content
- Different Referencing Styles
- Preparing manuscripts for Submission
- The Peer Review Process
- Addressing Editor’s Comment
- Best Practices in Preparing a Manuscript
- Medical Information: Standard Response Documents
- Communicating Risk and Benefit Information
- Developing Effective Slide Decks and Videos
- Preparing Patient Education Materials (Brochures, Patient Information Leaflets)
- Preparing Visual Aids and Infographics
- Developing Content for Patient Portals and Apps
- Use of Artificial Intelligence in Creating Content
- Principles of Clear and Concise Writing
- Common Grammatical and Stylistic Errors
- Techniques for Improving Readability and Engagement
- Use of Tables, Figures, and Graphics
- Editing and Proofreading Strategies
KL-MW03: Clinical Trial Transparency
This comprehensive course on Clinical Trial Transparency is designed to equip participants with the knowledge and skills needed to ensure transparency and ethical disclosure in clinical trials. The course covers regulatory requirements, best practices for data sharing, ethical considerations, and practical tools for implementing transparency in clinical research.
This course is ideal for clinical researchers, regulatory professionals, medical writers, and anyone involved in the conduct or oversight of clinical trials.
Individual participants can select either of the two models below
- Mentor-led (14 hours, to be covered over 8 weeks)
- Self-paced (Access to course material for 4 months)
By the end of this course, participants will be able to:
- Understand the importance of clinical trial transparency and its impact on public trust and scientific integrity
- Navigate regulatory requirements and guidelines related to clinical trial disclosure, data sharing, and plain language summaries
- Develop and implement strategies for ensuring transparency in clinical trial reporting
- Utilize platforms and tools for clinical trial registration, results reporting, and data sharing
- Address ethical and practical challenges associated with clinical trial transparency
Module 1: Introduction to Clinical Trial Transparency (CTT) (2 h)
- History and Development of CTT Requirements
- Scope of CTT
- Importance of CTT in Clinical Research
- Regulatory Requirements with a Focus on ClinicalTrials.gov, EU CTR 536/2014, and WHO
- Differences in Requirements Across Regions (USA and Europe)
- Introduction to Regional Registries
- Protocol Registration
- NIH Review Criteria for Protocol Registrations
- Results Disclosure
- NIH Review Criteria for Results Disclosure
- Clinical Trial Application Submission in Clinical Trial Information System (CTIS)
- EMA Policy 0070 and 0043
- Health Canada Public Release of Clinical Information
- Basics of Clinical Trial Data Sharing
- Basics of Plain Language Summaries
- Ethical principles in CTT; Data Protection Requirements
- Balancing Transparency with Patient Privacy
- Managing Commercially Confidential Information
