The certificate program in Clinical Trials Management provides a broad overview of key competencies necessary for a successful understanding and conduct of the new product development process in today’s environment. The program covers the logistics of site management, including start up, maintenance, and close out, with the corresponding collection and management of data. The program emphasizes the regulatory, privacy, and compliance issues critical to the successful approval of a new product for launch. The issues that the current environment poses for new product development, both in the U.S. and globally, are discussed and the students, through team simulations and interactions with experts in the field, are challenged to find ways to minimize their impact on new product delivery. The various roles integral to the development process are presented with focus on how they interrelate in a team model. The role of the trial subject/patient is described, with emphasis on safety and benefits potentially achieved in investigative trial participation.
- Offered online—This program is offered in a completely online format and takes 14 weeks to complete.
- Gain a complete perspective of clinical trials management
- Enter this challenging field, advance in your job, or build useful new skills
- Interact with industry and health care professionals
- Prepare for clinical research certification
The curriculum of the Clinical Trials Management Certificate covers core concepts consistent with the Academy of Clinical Research Professionals certification exams, a valuable credentialing opportunity for clinical research professionals.
To earn the Clinical Trials Management Certificate, all three of the following modules must be successfully completed with a grade of “C” or above.
Development: Setting Up the Environment for Success
This module provides an overview of the clinical and pre-clinical processes involved in setting up clinical trials, and the roles and responsibilities of those conducting and administering these processes. Topics include:
- Ensuring that a proposed investigative site is qualified and appropriate for use in a clinical trial
- Recruitment and retention of eligible study patients/participants
- Compliance with U.S. regulatory bodies and ethical considerations: safety, efficacy, privacy
- Comparison of human clinical testing models with animal testing models
- Setting up for collection and delivery of unbiased, concise, and comprehensive scientific data
- Code of conduct governing sponsors, sites, investigative personnel, and other affiliated parties
- Case studies of ethical and safety violations in clinical trials, and their effect on new product development
Implementation: Carrying Through the Plan
This module focuses on the processes involved in conducting safe, thorough, and reliable clinical trials. Topics include:
- Monitoring visits—purpose and importance of monitoring visits from the site and sponsor perspectives; roles and responsibilities of both site and sponsor in a successful outcome; essential points of a comprehensive site visit from both a regulatory and data management perspective; and what makes a highly proficient monitor
- Obtaining valid and reliable data—components of an appropriate database, validation of associated systems, coding principles, and the sequence of events leading to a database lock
- Emerging markets—how they contribute to the challenges of new product development, unique country/region mandates, effect of newly emerging markets in relation to the future of scientific experimentation
- Reporting of safety concerns—how to appropriately report them to regulatory agencies, regulatory timelines for reporting, case studies
Integration: Creating the Package
This module focuses on the steps necessary for completion and evaluation of clinical trials processes. Topics include:
- Ensuring that an investigative site has met all contractual and regulatory obligations
- Follow-up checklist: disposition of outstanding product supplies, report data, etc.
- Evaluation by the sponsor or agency regarding site and sponsor performance
- Audits surrounding an NDA (New Drug Application) filing, random and for-cause
- Introducing a product to health-care practitioners and consumers: market research, advertising principles, governmental rules and regulations, product branding
- Effectively reporting the outcome of clinical trials, including unbiased reporting to potential consumers regarding the results, limitations, and availability of the new product
Who should participate?
This certificate is appropriate for those professionals who have a strong science and/or health-care related background, including, but not limited to, nurses, pharmacists, medical technologists and physicians. Most employment opportunities in the industry require a minimum background of a bachelor’s degree. Two years of college level education is recommended for admission into the certificate program.
New product development requires a broad collaboration among science and technology professionals who keep current in the medical and regulatory arena. The potential opportunities in the field of clinical trials management range from the principal role of investigator to the supportive tasks surrounding regulatory compliance, scientific writing, marketing, and retrieval of accurate and reliable data for submission to regulatory agencies.
The research team collaborates across several business units, starting with the sponsor of the investigative new product, to the clinical site that collects ongoing data from subjects receiving the product, to the sponsor or designee who monitors the quality of the data being collected. Professionals conducting clinical trials primarily come from health-care backgrounds.
A clinical research professional may serve as a clinical investigator, sub-investigator, clinical researcher, research nurse, administrator, coordinator, data manager, project manager, IRB coordinator, quality assurance specialist, regulatory affairs specialist, research pharmacist, consultant, or educator in clinical trials management.
Clinical trials professionals are employed in a variety of settings:
- Pharmaceutical companies
- Biotechnology organizations
- Medical device companies
- Contract research organizations
- Educational institutions
- Independent contractors
It is expected that students entering the certificate will have a strong science and/or health-care related background. In addition, two years of college level coursework is recommended. The certificate provides the fundamental knowledge to enter the field of clinical research.
REQUIRED: laptop or desktop computer
- Required: a PC or Mac, laptop or desktop computer must be used to complete course activities like tests, quizzes, homework, or chats
- Required: high-speed Internet access
- Required: Mozilla Firefox browser, version 10 or newer
- Required: if not already installed on your computer, you may need to install these free plugins: Flash | Adobe Reader
OPTIONAL: mobile device
- Optional: most course video content can be viewed on a mobile device like a tablet, iPad or smart phone
- Mobile devices cannot be used to complete required course components like homework, tests, quizzes, chats
- Click here for details about mobile device compatibility