Fairplay Consultants, Inc. - CCRP Foundations of Clinical Research 5 Day Workshop

CCRP Foundations of Clinical Research 5 Day Workshop

Description:

Comprehensive five day training course geared for the entry-level CRA &/or CRC

Course Level:

Beginner

Overview:

Foundations of Clinical Research provides comprehensive good clinical practice (GCP) instruction. This course incorporates a blended learning approach combining computer lab work, classroom lecture, realistic case studies, work-related scenarios, role-playing, and group discussions to teach the basic principles and practices of clinical trials. Participants can conclude the one-week workshop with an on-the-job training experience at a mock investigator site.

Who Should Attend:

Everyone interested in an introductory course to clinical trial research conduct according to Good Clinical Practices (GCPs will find this course a MUST. This course is well-suited for the entry-level clinical research associate (CRA) and the clinical research coordinator (CRC) at the study site. Transitioning industry employees and research staff seeking professional growth will benefit from this course information. Members of the Institional Review Board will gain a better understanding of the overall clinical trial process by participating in these course activities. This exciting week of training is especially well-suited for:

CRA monitors CRC study coordinators Study site research staff IRB members

Objectives:

Explain the FDA phases and application process for drugs

Describe the Drug Development Process

Discuss the Informed Consent Process

Discuss the need for Sponsor SOPs and Site SOPs

Review the preparation and follow-up process related to a FDA audit

Outline the CRC/CRA roles during the clinical trial at the Investigator Site

Agenda:

Phases of Clinical Research

* The Preclinical Phase of Drug Development: From Assays to Animals * Animal Models * Clinical Studies: The First Step in Human Exposure

Regulation of Clinical Research

* Early Regulation: Up to 1938 * Regulation from 1938-1980 * Current Legislation and Regulation: 1980-Present * From Laws to Regulations

Medical Device Regulations and Clinical Research

* The Federal Food, Drug, and Cosmetic Act of 1938 and Medical Devices * The Medical Device Amendments of 1976 * Devices by Class and Category * Premarketing Approval * Investigational Devices * Significant and Nonsignificant Risk Device Studies * The Safe Medical Devices Act of 1990

Protecting Human Subjects

* Standards of Ethical Behavior * The Institutional Review Board * IRB Review: Requirements for Approval * The Informed Consent Form

Protecting Privacy and Confidentiality of Research Subjects

* The Concepts of Privacy and Confidentiality in the Context of Research * Existing Regulations and Statues * Privacy Provisions of HIPPA of 1996 * Highlights Pertaining to Research * Applying the Privacy Rule to Clinical Research * Privacy Rule Enforcement and Guidance

Roles and Responsibilities

* Sponsor/CRO Roles and Responsibilities * Investigative Site Roles and Responsibilities * Role of the IRB * Roles and Responsibilities of FDA

The Clinical Protocol & Investigator Brochure

* Research Theory * Protocol Design * Investigator Brochure

Clinical Trials Management/ Site-Sponsor Interactions

* Study Planning * Site Initiation * Ongoing Through Completion * Study Termination

Federalwide Assurance and Federally Funded Research

* Federal Regulations and Institutional Responsibilities * Investigator Responsibilities and Informed Consent * Human Protections Program Administration and IRB Responsibilities

Accreditation of Human Research Protection Programs

* Need for Reform and Accountability * Human Research Participant Protection Program (HRPPP) * Accreditation Bodies: AAHRPP and PHRP

Please note:

If you would like to see this course offered in your area, please contact us for scheduling opportunities and fees.

For further training in this subject area, please consider:

Advanced Training for CRAs and CRCs

Notes:

The next step in the learning curve is case study scenarios, writing standard operating procedures, and resolving real-life daily situations encountered in clinical trials.