Advanced Coordinating Techniques
GW 1066 and 1064. This module offers an advanced overview of clinical trial coordination, with an emphasis on resource utilization, time management and coordinating mechanics.

Advancing Medical Device Research
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.

Building Study Budgets
GW 1044 – This module offers a basic overview of study budgets including identification of budget items, estimating per-patient costs and activity based training.

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.

Device Dynamics: Successful Management of the Medical Device Trial
GW 1841 – This module 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 the role of the IRB review and approval, communication and reports, record keeping and principles of informed consent.

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.

GCPs 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.

GCPs 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 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.

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 deficiences.

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.

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.

Patient Recruitment
GW 377 – This module offers strategies for successful patient recruitment. It includes rules for recruitment, making the most of the local media, challenges in recruitment, techniques and confidentiality.

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.

Preparation for Medical Device Trials
GW 2768 – This module includes an overview for preparing for medical device trials. Also included are protocol development, clinical supplies, CRFs, source documents, regulatory documents, responsibilities of the investigator and financial disclosure.

Recruiting Strategies and Hazards
GW 664 - This module offers strategies for successful patient recruitment and reviews potential hazards. It includes rules for recruitment, making the most of the local media, challenges in recruitment, techniques and confidentiality.

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.

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 tables, time lines and tools.

Test Article Accountability
GW 1660 – This module includes basic information of test article accountability and includes product accountability, storage and handling, randomization, preparation and dispensation, reconciliation, return and disposition.

Course Registration and Pricing