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Advanced Quality Monitoring
Coordinating a Clinical Trial
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GCP:Medical Device
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Seminar Title: Coordinating a Clinical Trial
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Course Description

This course is designed to provide a brief overview of clinical research, terminology, and acronyms followed by a comprehensive review of FDA Regulations, FDA Guidance on the Supervisory Role of the Investigator, and ICH GCP (E6) Section 4. It also reviews the fundamental elements involved in coordinating a clinical trial from the investigator’s perspective. It includes, the review of SOPs, strategies on study preparation to prevent non-compliance, subject recruitment / retention, GCP compliant consenting, budget assessments and determining if a protocol is practical for your site. The participant performs the following activities: FDA Form 1572 exercise, source document gap analysis, protocol preparation for subject eligibility, AE drill, ICF documentation exercise, source documentation drill, ad reviewing a mock study budget. MRM provides each participant with a CD-ROM Regulatory Reference.

Course Objectives

  • Discuss the drug/biologic development process.
  • Define GCP and identify its application in clinical research.
  • List the key components of a clinical trial.
  • Determine the GCP requirements for the informed consent, adverse and serious adverse events, source documentation and study drug accountability.

Daily Agenda / Course Topics

Day 1

I. Overview of Clinical Research

  • IDE Studies and IND Studies (Phases & Data Focus)Phases of Research
  • Acronyms, Terminology, & Forms
  • Roles and Responsibilities of the Clinical Research Team

II. FDA GCP & ICH GCP-The Investigator's Perspective

  • FDA Guidance: Investigatory Supervisory Role, October 2009
  • FDA GCP: Investigator Obligations 21 CFR312
  • ICH GCP (E6) Section 4: Investigator
  • FDA Form 1572 "Statement of the Investigator"
    • FDA Form 1572 Completion and Review Activity
  • Electronic Records and Signatures
  • Financial Disclosure by Clinical Investigators
  • IRB Role and Responsibility
  • Informed Consent Requirements & Documentation
    • Exceptions, Assent, and the use of a Legal Authorized Representative
  • ICH GCP (E6) Gap Analysis with FDA GCP: Consent and Drug Accountability
  • HIPAA: Research Authorization Requirements
  • Informed Consent Compliance Exercise

Day 2

III. Clinical Trial Fundamentals

  • Recommended Standard Operating Procedures (SOPs)
  • Study Start up Preparation, Subject Recruitment/Retention, and
  • Source Documentation Strategies
  • Investigational Medicinal Product storage, Documentation, and Potential Issues & Prevention GCP compliance using the 8 R’s of Consent and Documenting using the TAPC Note
  • Source Documentation Strategies Developed after Performing a Source Document Gap Analysis
  • Budget Analysis and Protocol Feasibility Assessments
  • Adverse Event definitions (ICH GCP E2A, and ISO 14155-1:2003)
    • Adverse Device Effects & Serious Adverse Device Effects
    • Serious Adverse Events • Unanticipated Adverse Device Effects
  • AE Drill Exercise

Who Should Take This Course

Clinical Research Professionals interested in obtaining solid knowledge of the GCP and HIPAA requirements, and the fundamentals to running a successful clinical trial at the research site.

Dates / Times / Accommodations

Seminar Dates Seminar Location Seminar Time Seminar Fees
Register by Phone: 877-633-3322
Print Application (pdf) and Fax To: 954-346-2791
Ask About Student Discount (Availability limited)

Contact Hours

Florida State Provider #50-11408, Provider approved by the California Board of Registered Nursing, Provider #CEP 13617 for 11 contact hours. Credits can be applied to ACRP certification.

Cancellations and Substitutions

Cancellations by registrants must be provided in writing prior to the start date of the seminar, such registrants shall receive a credit voucher toward a future MRM seminar. Companies may substitute someone registered with another participant at any time. MRM reserves the right to cancel a seminar due to poor enrollment or acts of nature and shall not be responsible for any airfare, hotel, or other costs. MRM shall offer a credit voucher to a future seminar or a complete refund for MRM Seminar cancellations. Seminar topics and speakers may be subject to change without any prior notice.
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