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Advanced Monitoring
GW 403 and 721 – Focusing on how auditors review data, this module provides an overview on detecting fraud and fabrication, advanced monitoring techniques and report writing.
Advancing Medical Device Research
GW 1836 – This module offers a regulatory review and current perspective on medical device research. Also addressed are medical device
Adverse Device Effect Reporting
GW 1836 – This module offers a regulatory review and current perspective on medical device research. Also addressed are medical device challenges ranging from regulatory rigor to subject recruitment and protocol compliance.
Adverse Experience Data Collection & Reporting
GW 1483 – This module offers an overview of adverse events and includes information on AE CRF completion, seriousness vs severity, causality assessments and coding systems.
Clinical Trial Execution
GW 670 – This module discusses the basics of clinical trial execution and includes clinical research SOPs, documentation, investigational product accountability, confidentiality of records and record storage.
Clinical Trial Management Activities
GW 671 – From a clinical trial management perspective, this module offers information on clinical laboratories, regulatory files, investigational product accountability and site management, communication and documentation.
Clinical Trials Preparation
GW 648 – This module discusses preparing for a clinical trial. It includes topics on protocol development, clinical supplies, source documents, CRFs, financial disclosure and Form FDA 1572.
Closeout Visits
GW 622 – This module includes a basic overview on closeout visits as well as clinical supplies and files, record retention, report obligations and closeout visit checklists.
Conducting Monitoring Visits
GW 734 – This module offers information on conducting monitoring visits as well as how to set up data tracking sheets, scheduling and preparing for the monitoring visit, reviewing study progress and CRFs, verifying source document data and how to monitor efficiently, timing and travel tips.
CRA Survival Techniques
GW 855 – This module offers an informative course for CRAs on how to survive their tough job. It includes office organization, time management, stress management, career management and travel savvy.
Device Dynamics: Successful Management of the Medical Device Trial
GW 1841 – This modules offers information on how to successfully manage a medical device trial. It includes a GCP and regulatory review, pharmaceutical research vs medical device research, challenges in medical device trials, common regulatory deficiencies found in medical device trials, future trends and informative exercises.
Drug Development Process
GW 735 – This module offers a basic overview of the drug development process from conception through application for marketing. It offers a GCP as well as historical and regulatory review of clinical research and the phases of the drug development process.
Electronic Data Capture
GW 933 – This module offers a full review of electronic data capture. It includes information on how it relates to 21 CFR 11, electronic data management, electronic signatures, record retention requirements and auditing EDC systems.
Ethics Review and the Protection of Human Subjects
GW 857 – This module offers a basic ethics review in the protection of human subjects. It includes
GCP and Investigative Site Responsibilities
GW 316 – Geared toward the investigative site personnel, this module offers a review of ethics in research, protection of vulnerable populations, principles and elements of informed consent, financial disclosure, regulatory documents and device accountability.
GCP Compliance
GW 352 – This module offers a basic overview of GCPs and includes information on sponsor responsibilities, informed consent, financial disclosure, delegation of authority, device accountability and FDA audits at investigational sites.
GCP and Coordinating Medical Device Trials
GW 2365 – This module contains information on the coordination of medical device trials. It includes information in investigational device exemption, off-label and humanitarian use of devices, medical device trial challenges and adverse device effect reporting.
GCP and the Protection of Human Subjects
GW 389 – This course offers a review of GCPs and how they relate to the protection of human subjects. It includes information on regulatory documents, drug accountability, ethics in clinical research, protection of vulnerable populations, principles and elements of informed consent as well as financial disclosure
Good Clinical Practice for Clinical Research
GW 416 – This one day course offers an introduction to clinical research, information on ethics, research and the law, clinical research team roles and responsibilities, clinical trial preparation and clinical trial execution.
Good Clinical Practices Applications (Devices)
GW 1071 – This module offers a practical look at GCPs and includes information on the clinical research team, regulatory documents, device accountability and common FDA audit findings.
Good Clinical Practices Applications (Drugs)
GW 897 - This module offers a practical look at GCPs and includes information on the clinical research team, regulatory documents, drug accountability and common FDA audit findings.
Informed Consent
GW 665 – This module offers a basic overview of the informed consent process and includes principles and elements of informed consent, writing the consent document and administering informed consent.
Initiation Visit
GW 650 This module includes a basic overview of initiation visits as well as preparing for an initiation visit, initiation checklists, ensuring compliance with investigator responsibilities, reviewing the protocol and CRFs, checking facilities, equipment, verifying anticipated enrollment and checking supplies and fees.
Introduction to Clinical Research
GW 643 – As an introductory course for clinical research, this course offers information on historical and regulatory perspectives, GCPs, the drug and device development processes and industry vs. NIH sponsored trials.
Investigational Product Accountability (Devices)
GW 684 – This module contains information on investigational product accountability for devices and includes product accountability, storage and handling, randomization/preparation/dispensation, reconciliation and return/disposition.
Investigational Product Accountability (Drugs)
GW 686 – This module contains information on investigational product accountability for drugs and includes product accountability, storage and handling, randomization/preparation/dispensation, reconciliation and return/disposition.
Investigational Product Development Process
GW 645 – This 2 hour module contains information on the investigational product development process. It includes a historical and regulatory perspective, basic GCPs and the drug and device development process.
Managing Medical Device Trial Challenges
GW 687 – This module offers basic information on medical device trial challenges and includes information on patient recruitment, informed consent, product accountability, protocol compliance and common regulatory deficiencies.
Managing Site Performance Problems
GW 626 – This module offers comprehensive training on how to manage site performance problems. It includes how to analyze performance problems, practical tips on how to handle sites and sponsors and real world case studies.
Medical Device GCP Overview
GW 1075 – This one hour course provides a basic overview of GCPs as they relate to medical devices. It includes a historical and global regulatory perspective, a review of the Code of Federal Regulations, role of the FDA, sponsor and investigator obligations.
Medical Device Regulatory Review
GW 688 – This module offers a regulatory review as it relates to medical device research. It includes historical & global perspectives, a review of the Code of Federal Regulations, International Conference on Harmonization (ICH) Consolidated Guidance, comparison of ICH and U.S. CFR, current regulatory options for medical device development and common regulatory terminology.
Monitoring Applications
GW 690 – This module contains information on essential information on monitoring. It includes a regulatory document review, CRF review, document verification and fraud detection.
Monitoring Essentials
GW 661 – This module focuses on the basic essentials for monitors: purpose, preparation, conduct and reports.
Monitoring for GCP Compliance
GW 1577 – This module offers an overview of monitoring for GCP compliance. It includes a clinical research team overview, regulatory document management and clinical trial material overview.
Monitoring Report Writing
GW 774 – This module focuses on the basics of writing a monitoring report. It includes topics such as purpose of monitoring reports, format of the report, content of the report and the entire report writing process.
Monitoring Visits
GW 621 – This module includes a basic overview of monitoring visits including preparing for the visit, reviewing study progress, CRF review, source document verification, visit reports and tools and tracking systems.
Overview of Clinical Research
GW 1040 – This module offers a broad overview of clinical research and includes overall goals of the sponsor, investigator and regulatory bodies, how to fully integrate these goals together and how to differentiate between medicine and research.
Practical Applications of GCPs
GW 653 – This module contains multiple real world examples and class exercises with GCP in mind.
Practical Applications of GCPS II
GW 2986 – As a continuation of Practical Applications of GCPS I, this module offers a basic review of GCPs, then reviews real world examples and class exercises.
Pre-Study Visits
GW 649 – This module includes a basic overview of pre-study visits including evaluating an investigators' experience, qualifications and capabilities, evaluating investigators' staff and facilities, evaluating interest and availability and a pre-study checklist.
Principles of Documentation for Field Monitors
GW 1664 – This module includes basic documentation principles for field monitors and includes information on effective writing of reports and letters, how to present data and the Who, What, When, Where and Why of monitoring reports.
Query Management
GW 1061 – This module offers an overview of query management and topics that include the data management process, query resolution strategies and obligations for queries from sites and sponsors.
Regulatory Overview
GW 1076 – This module offers a regulatory overview and contains information on GCPs and CFRs as well as the role of the FDA in clinical research.
Regulatory Update
GW 692 – This module offers an up-to-date review of current regulatory happenings.
Research Fundamentals
GW 693 – This one hour session covers the basics of clinical research and includes an introduction to the scientific method, differentiating between medicine and research and investigational plan vs. protocol.
Sponsor Visits
GW 898 – This module includes a basic overview of all forms of sponsor visits including pre-study, initiation, monitoring and close-out.
Study Management Guidelines and Techniques
GW 700 – This module offers tips on study management guidelines and visits. It includes pre-study, initiation, monitoring and close-out visits as well as coordinating strategies for successful trials.
Supplemental Study Specific Documents
GW 2772 – This module offers information on specific regulatory documents required for clinical research. It includes informed consent documents, issues in CRF designs and study table, time lines and tools.
Course Registration and Pricing
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