Training Program Title

Clinical Investigator GCP & Trials Management Program for Clinical Investigators and Key Research Staff

CTSA Hub Administered

no

Contact Information

Contact us by email at office@socra.org or by phone at 215-822-8644.

Training Program Description

The purpose of this workshop is to assist Clinical Investigators and key research staff in improving their skills and their understanding of the responsibilities of the clinical research site. This program is intended to share information and create opportunity for dialogue among clinical investigators, key research staff and program faculty. The specific goal is to enhance the participants’ ability to perform quality clinical research according to existing regulations and guidelines. This program is designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines). The goal will be accomplished through lecture and practical application facilitated by clinical research professionals. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Council on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.

Competency Keywords

Study design, IRB, Research participants, Best practice, Research study management, Protocol, Regulation, Billing, Audits, Communication, Investigational products

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

yes

Competency Domains

Clinical Trials Operations; Study and Site Management

Learning Objectives

Learning Objectives: Upon completion of this course the attendee should be able to:

  • Describe the Drug Development Process
  • Discuss Investigator and investigational site responsibilities related to regulations and ethics
  • Describe the Protocol Development Process
  • Describe the Research Grant Proposal Development Process
  • Discuss the Informed Consent Process
  • Explain Development of Informed Consent Forms: Rights, Rites, and Rewrites
  • Describe Investigator-Initiated Research Projects
  • Discuss Safety Reporting and Adverse Events / Serious Adverse Events
  • Explain Source Documentation and Research Record Management
  • Discuss the Financial Management of Study Funds
  • Discuss the Elements Related to Successful Successful Clinical Study Agreements
  • Describe the Basic Requirements of Monitoring Visits and Audits
  • Discuss the Development and Implementation of Standard Operating Procedures

Delivery Method

In-person

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level

Skilled

Onboarding

no

Frequency

Annually

Time Needed

2 Day Conference (13.25 hours of CE credit available)

Associated Assessment

yes

Assessment Methods

Overall satisfaction

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