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Clinical Trials: Study Preparation
This eLearning module is part of the Clinical Trial Fundamentals eLearning Program and is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. Using an interactive case study with realistic scenarios designed to illustrate the learning points, the program follows the activities of a fictitious clinical investigator and her staff as they conduct a clinical trial.
Upon completion of this module, learners should be able to:
- Differentiate the roles and responsibilities of the clinical investigator, the study staff, and the sponsor
- Identify the clinical phases of drug development and what is done at each phase
- Discuss the regulations and Good Clinical Practice guidelines on conducting a clinical trial
- Explain the foundations of ethical conduct in clinical research including its impact on clinical research
- Explain the history behind human subject protection
- Explain different study designs and discuss the merits of each
- Explain how to determine a study budget
Introduction to Drug Safety
This module provides a foundation of knowledge required to work day-to-day in clinical safety and pharmacovigilance. It provides information on the legal basis for safety reporting, including a historical perspective; basic definitions and tools; the mechanics of drug safety and pharmacovigilance; reference safety information provided by the Investigator’s Brochure and postmarketing labeling; and evaluation of seriousness, expectedness, and causality of adverse events.
Upon completion of this module, learners should be able to:
- Discuss the history, principles, and regulatory framework for clinical drug safety
- Define terms used in day-to-day pharmacovigilance work
- Describe a typical company drug safety unit and the path of a case from start to finish
- Explain reference safety information provided by the Investigator Brochure and postmarketing labeling
- Explain the assessment of seriousness, expectedness, and causality of adverse events
Overview of Drug Development
This module is part of the DIA Drug Development and Life Cycle Management eLearning Program. The Overview of Drug Development module provides a grounding in the breadth of activities required to move a potential drug candidate from idea to the marketplace, with an emphasis on how various functional areas contribute at each stage of development, and how they are organized. It also discusses the regulatory environment in which these activities occur.
Upon completion of this module, learners should be able to:
- Describe the phases of drug development
- Identify the sources of drug development regulations
- List the functional areas involved in the drug development process
- Describe the workflow for bringing a new drug to market
Database Management and Medical Inquiries
This module is part of the Medical Communications eLearning Program (eight modules) and provides the medical affairs professional with an overview of the utility and application of database management systems in the Medical Communications or Information Department. It will also assist the medical communications professional in fielding questions, retrieving information, and delivering responses verbally.
Upon completion of this module, learners should be able to:
- Describe the role, features, and design of a database management system for the Medical Communications/Information Department
- Explain the process involved in responding to medical information requests and documenting the request in the database management system
- Describe the various types of responses to requests for medical information
- Explain additional functions of a database system
- Identify and evaluate the sources of information available when preparing a response
- State guidelines for developing a response, including when a verbal response versus a written response should be given, and the advantages of a written follow-up
- Differentiate between fair balance and scientific balance
- Describe situations the medical communications professional should be prepared for when delivering a response
- Prepare for issues that may arise due to the type of caller or the type of inquiry
- Describe methods for documenting, storing, and reviewing responses
Informed Consent: Comprehensive Concepts and Components
This comprehensive module provides the key concepts of informed consent. It explains the components of a complete and appropriate consent form as specified by the International Conference on Harmonisation (ICH) and the US Food and Drug Administration (FDA), as well as guidance for the creation and appropriate wording of these components. It also includes a discussion on the benefits and concerns with electronic informed consent, and presents publications and projects that explore the use of eConsent.
Upon completion of this module, learners should be able to:
- Define informed consent and identify the key characteristics of the process
- Identify situations that would require informed consent, and exceptions to consent
- Explain the proper methods of communicating with and gaining consent from various populations of potential study subjects
- Explain the proper use of electronic consent, its benefits, and concerns with its use
- Identify common problems with completed consent forms
- Write a complete and appropriate consent form
- Determine which consent form components are necessary based on the characteristics of the study and potential study subjects
- Analyze completed consent forms for comprehensiveness, appropriateness, and accuracy
- Describe the difference between short and long consent forms, and explain when each is appropriate
- Summarize informed consent requirements under HIPAA