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Use this form to search course ID, name, description, outline, and objectives. This is a multiple word search. Each word must be 3 characters or more (e.g., GMP, GCP, Clinical, etc). Shorter words and any special characters will be ignored. You can search courses for things such as GMP001S1, GAMP, Pharmacovigilance, Quality Assurance, ALCOA, Validation, Clinical Trials, CFR Part 820, Cleaning Validation, or Drug Safety.
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Searching courses for: Clinical Trials
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Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials RegulationTo conduct a clinical trial in one or more member states (MSs) of the European Economic Area (EEA) a sponsor must first gain the approval of each relevant national regulator and the favorable opinion … |
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Clinical Trials Management (US & EU) Professional Certification ProgramThis Clinical Trials Management (US & EU) Program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. It is also valuable for tho … |
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Clinical Trial Safety Reporting Requirements in the EU and USAThis course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the fou … |
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Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials RegulationThe European Union (EU) Clinical Trials Regulation ensures that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the European Economic Ar … |
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Clinical Trials: Preparation and DesignWorldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical tria … |
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Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EUTo conduct a clinical trial in the European Economic Area the sponsor must apply for authorization from the national competent authority (i.e. medicines regulator), and favorable opinion must be obtai … |
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Clinical Research Associate (CRA) Professional Certification ProgramGCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensur … |
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Clinical Trials and Drug DevelopmentThis course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials are outlined. … |
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Clinical Research Coordinator (CRC) Professional Certification ProgramThe Clinical Research Coordinator (CRC) Professional Certification Program provides a strong foundational understanding of clinical trails and all stakeholder responsibilities. This program emphasizes … |
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The General Data Protection Regulation (GDPR) and Clinical TrialsThe General Data Protection Regulation (GDPR) and Clinical Trials course covers how to exchange personal data during and after study conduct while following the GDPR requirements for data protection. |
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Clinical Trials in Drug Development (Fundamentals)Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. Given the fina … |
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Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)From the EU Clinical Trials Directive to the Clinical Trials Regulation, the content includes an overview of the requirements for the conduct of clinical trials in the European Union, the EU Regulatio … |
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Obtaining Approval for Clinical Trials in US & EU for Regulatory ProfessionalsThe Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals program is designed for regulatory affairs specialists, managers, directors, and project managers. The program may al … |
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Safety Reporting in Clinical Trials (Adverse Event Reporting)This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and h … |
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Clinical Trials: Preparation (Fundamentals)Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. Given the fina … |
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GCP: ICH-GCP Good Clinical PracticeGood Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP … |
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Clinical Trials: Protocol Design (Fundamentals)Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. Given the fina … |
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Clinical Trials: Statistical Elements (Fundamentals)Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. Given the fina … |
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HIPAA Training for Clinical Trial ProfessionalsThis Health Insurance Portability and Accountability Act (HIPAA) training for Clinical Research Professionals covers best practices for sites and |
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Clinical Trials: Endpoints (Fundamentals)Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. Given the fina … |
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Overview of ICH E8(R1): General Considerations for Clinical Studies GuidelineICH E8(R1) is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, an … |
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Clinical Trials: Data Capture (Fundamentals)Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. Given the fina … |
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Clinical Trials: Study Design (Fundamentals)Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. Given the fina … |
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Investigator Initiated Clinical TrialsWhat are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved … |
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GCP: ICH, Harmonization, and Principles (Fundamentals)The drug industry is one of the most heavily regulated in the world. The steady increase in globalization of the industry has motivated efforts to harmonize regulatory requirements – that is, to achie … |
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Drug Safety and Pharmacovigilance Professional Certification ProgramThis training program provides a comprehensive overview of the requirements and concepts necessary to attain a strong understanding of drug safety and pharmacovigilance.Drug safety monitoring and risk … |
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Clinical Trials: Preparing for an Audit or InspectionGood Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the res … |
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DIGR-ACT® Solution: Critical Thinking Skills – Including Root Cause Analysis & CAPADIGR-ACT® is a solution that uses critical thinking for issues prevention and management. |
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Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsThe Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical studies with an investigational … |
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Clinical Trial Monitoring: Documentation and ClosureThe sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and … |
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ICH E6(R2) GCP Training for Investigator Site PersonnelThis Investigator Site Personnel Good Clinical Practice (GCP) course covers the requirements of GCP for clinical trials found in ICH E6(R2) related to the role of the investigator and site personnel, … |
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GCP: Clinical Research Teamwork (Fundamentals)A clinical trial, particularly a late-phase commercial study, is a major project requiring collaboration between the sponsor and staff or contractor, on the one hand, and the clinical investigator(s) … |
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GCP: Clinical Trial Sponsors GCP Responsibilities (Fundamentals)The sponsor takes responsibility for the trial’s initiation, management, and/or financing. A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a contract research … |
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GCP Training: ICH E6(R2) – (Refresher Training for Novice)This GCP Training: ICH E6(R2) course covers key components of the GCP requirements for clinical trials, found in ICH E6(R2), and relates to the roles and responsibilities of the investigator, sponsor, … |
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Regulatory Affairs: Registration of Drugs Based on Monoclonal AntibodiesThis course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of … |
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GCP: Clinical Trial Documentation (Fundamentals)Regulatory authorities tend to abide by the maxim that ‘If it isn’t documented, it didn’t happen’. Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of Good Cl … |
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Clinical Trial eSystems Inspection ReadinessThe use of electronic systems to support critical endpoint and safety data continues to increase. A clinical eSystem is an electronic system used to support the clinical trial, such as to collect, han … |
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GCP: Informed Consent in Clinical Trials (Fundamentals)Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference b … |
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GCP: Clinical Trial Investigators GCP Responsibilities (Fundamentals)The investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects … |
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GCP: Clinical Trial Monitors GCP Responsibilities (Fundamentals)A clinical trial monitor acts on behalf of the sponsor to support investigational site personnel, verify the accuracy of data recorded, and ensure that the trial is conducted in compliance with the pr … |
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Clinical Trial Monitoring: Site Evaluation and Set-upThe sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to b … |
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Good Pharmacoepidemiology Practice Professional Certification ProgramThis program provides a comprehensive overview of the requirements and concepts necessary for a strong understanding in good pharmacoepidemiology practice (GPP). The program also includes detailed des … |
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GCP Refresher Training for the Experienced ProfessionalThis Good Clinical Practice (GCP) Refresher course reviews the major requirements of GCP for clinical trials according to the global guideline ICH E6(R2) related to roles and responsibilities. The cou … |
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Structure and Content of Clinical Study Reports (ICH E3)This course covers the ICH E3 Guidance as well as the E3 Questions and Answers complement. Content includes an overview of ICH E3, an overview of the clinical study report or CSR, the body of the clin … |
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Drug Safety: Signal Detection and Management in PharmacovigilanceThe fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then ta … |
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Medical Device vs. Drug: Comparing and ContrastingThis course covers major differences between medical device and drug clinical trials, including key definitions, regulatory approval and application processes, and safety reporting, with a focus on F … |
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CRO OversightCRO and vendor oversight is a topic that is important to all Sponsors that are outsourcing clinical trial duties or activities to support the factors that are critical to success of their product deve … |
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GxP: Good Practices (GxP) in Drug Development and ManufacturingThis short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulat … |
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Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)This course covers an overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA). Content includes 21 CFR Part 312 relatin … |
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Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IECThis course covers an Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC. Content includes key components of human subject protection, definitions and scope for Part … |
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US Pharmaceutical Regulatory Affairs Professional Certification ProgramThe US Pharmaceutical Regulatory Affairs Program describes the essential requirements for obtaining approval to market a new drug in the USA, the ‘NDA Process’.The program describes preparing submissi … |
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Good Documentation Practices and ALCOA-CIn this course, you will learn about Good Documentation Practices, including the ALCOA-C principles, notes to file, and other general documentation procedures. Good Documentation Practices are necessa … |
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Regulatory Affairs: Essentials for Human Medicinal Products – EU and USThis foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in or … |
