International Online Master in Clinical Trial Monitoring
Madrid, Spain
DURATION
1 Years
LANGUAGES
Spanish
PACE
Full time
APPLICATION DEADLINE
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EARLIEST START DATE
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TUITION FEES
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STUDY FORMAT
Distance Learning
Key Summary
Introduction
The International Online Master's Degree in Clinical Trial Monitoring has been designed with the aim of enabling students to develop a solid knowledge base in matters of international clinical research in humans, as well as master the requirements inherent to the successive phases and processes in this field.
Students are prepared to assume responsibilities for monitoring and controlling clinical research under current quality requirements during this analysis period.
Specialized training in this field provides students with access to new opportunities for professional development, due to the growing demand for professionals who are experts in the implementation and monitoring of R&D projects.
- Practical and applied ONLINE methodology: The development of knowledge through active methodologies applied to online training models allows students to combine their studies with the rest of their professional and personal life obligations.
- Personalized monitoring: In addition to the teaching staff, students will have a group of tutors at their disposal who will personally monitor their progress, to guide the student at each stage and resolve any difficulties they may face during the course.
- Connection with the reality of the sector: Both the role of the Program Manager of the course, who has designed and directs its delivery, and the teaching faculty are made up of active professionals, guaranteeing the connection with the working reality of all students and the direct application of the knowledge they acquire during the course to their workplace.
Technical Sheet
General information
- Duration: 1 academic year
- Equivalence: 60 ECTS
- Methodology: 100% online
- Continuous assessment of knowledge
Calls
Students have the opportunity to plan their training schedule together with their tutors. In this way, each future student can establish the time when the rest of their responsibilities will allow them to achieve the best academic performance and the time to apply the knowledge acquired during the course in their professional field.
Methodology
This Online Master's program is developed over 1 academic year.
During this period, 2 virtual classes will be activated per week and each student will have the possibility of requesting from their personal tutor the virtual tutorials they deem necessary to resolve any difficulty they may encounter during the study of content.
- 24/7 virtual campus: students can access it 24 hours a day, 7 days a week from any device with an Internet connection.
- Compatible with work and family life: each student decides where, when and how they want/can access the course content, taking into account the rest of the professional and family responsibilities that occupy their daily lives.
- Personalized advice: from the first moment to the end of the training process, students will be accompanied by qualified professionals who they can turn to to resolve any difficulties they may encounter.
- Constantly updated content: To ensure the highest quality of our training, our content is subject to continuous review and updating by our teaching staff, ensuring the direct application of the knowledge acquired during the course in the professional field.
Admissions
Curriculum
The International Online Master's Degree in Clinical Trial Monitoring is made up of the following content blocks:
Scientific bases
- Introduction to pharmaceutical clinical development.
- Pharmacokinetics.
- Pharmacodynamics.
- Toxicology.
- Basic concepts on Clinical Research methodology.
Organizations and actors participating in clinical trials
- Main responsibilities and functions of the actors involved in the development and management of Clinical Trials.
- The environment of the Pharmaceutical Industry.
- Contract Research Organizations- Cros.
- Hospitals and Health Centers. Clinical Research Ethics Committees I.
- Clinical Research Ethics Committees II and Health Agencies.
Design and phases of clinical trials
- Types of studies according to their methodology.
- Types of studies according to their methodology (Continued). Scientific evidence. Meta-analysis.
- Origin of clinical trials. Regulation.
- The biology of medicine. Pharmacogenetics. Pharmacogenomics. Genetic Profiling. Immune Therapy.
- Fundamentals of clinical development. Phase 0 clinical trials.
- Phase I clinical trials.
- Phase II clinical trials.
- Phase III clinical trials.
- Post-Authorization Studies.
- New clinical trial designs and new regulatory pathways.
Regulatory environment
- GCP, ICH, Declaration of Helsinki.
- FDA legislation.
- Regulation of EECC.
- Ehealth and the new EU data protection regulation.
Stages of clinical trials
- Feasibility of clinical trials.
- Identification and selection of centers and researchers.
- Recruitment material and strategies.
- Upm.
- Contracts with research centers.
- Personal data protection.
- Protocol.
- Patient information sheet and informed consent.
- Essential Documents in an EECC.
- Monitoring: Purpose and Responsibilities.
Clinical trial monitoring.
- Pre-study visit.
- Home visit.
- Monitoring visit.
- Closing visit.
- Other monitoring visits.
- Remote monitoring.
- Risk-based monitoring.
- Monitoring visit reports.
- Follow-up and meetings with research teams
- Patient: Screening, Randomization, Dropout.
- Essential documents to review during a monitoring visit.
- Administrative work in clinical trials. Archive.
- Data collection notebook.
- Data processing in clinical trials.
- Sample handling in clinical trials.
- Types and Purpose of Audits.
- Preparation, course and follow-up of audits.
- Key audit findings.
Pharmacovigilance
- Pharmacovigilance in clinical trials. Legal framework, definitions and management of adverse events (European legislation, FDA and in Spain, definitions of adverse events and others, Safety management plan, SMP).
- Adverse event reporting, Eudravigilance. (Notification of adverse events, reporting times and procedures, types of reports CIOMS, Medwatch Report, Eudravigilance and safety databases).
- Periodic safety reports (DSUR, SAES and AES Line Listings, Quarterly and Semi-Annual Reports).
- Pharmacovigilance in other clinical trials: post-authorization studies, clinical trials with medical devices and clinical trials with vaccines and advanced therapies.
- Audits and inspections. Signal detection.
Biometrics and data management
- Classification of statistical studies. Classification axes.
- Types of variables. Measurements.
- Hypothesis testing. Confidence intervals.
- Risks. Relationship between variables.
- Population and sample.
- Queries, Statistical design.
- Statistical analysis plan and statistical report.
- Functions and tasks. Statistics unit.
Medical Affairs in clinical research
- General concepts Medical Affairs
- Most relevant roles in Medical Affairs
- Interactions between Medical Affairs and other departments (Clinical Operations & Commercial Departments).
Professional development
- Professional career: importance, path and professional development after completing the master's degree.
- Career options and structure of the local and international labour market.
- Effectiveness and tools in the job search.
- Job interview: essential elements for success in the selection process.
- Professional life, skills and qualities to develop as a Clinical Trials monitor.
Career Opportunities
The pharmaceutical sector offers a very dynamic job market for positions related to clinical research and medical-scientific activities, both in pharmaceutical laboratories and in companies that carry out contract research (CROs).
Professionals working in this field perform highly qualified tasks and have an attractive and competitive professional development ahead of them. The Master's degree provides access to, among others, the following sectors of activity:
- Pharmaceutical laboratories.
- Contract Research Organization (CRO).
- Hospitals.
Students will have acquired solid specialized knowledge that will allow them to achieve professional career development within the following industrial departments at national and international level:
- Clinical operations department: clinical trials, project coordination and biometrics.
- Scientific department: pharmacovigilance, medical affairs, pharmacoeconomics and medical marketing.