eMedevents
  • 146,609+ Medical Conferences
  • 284 Specialties
  • 10,922 Organizers
  • 154,749 Speakers
  • 156 Countries
  • 4,686 Cities
48,870+
CME Conference Registrations Sold
Home  >  Conferences  >  Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors (Feb, 2020)
CE Credits : 14 | CME : 14

Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors (Feb, 2020)

Feb 13 - 14, 2020   |   St Pete Beach, Florida  United States Of America
  Register Now
Conference Brochure

Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors is organized by Society of Clinical Research Associates (SOCRA), Inc. and will be held from Feb 13 -14, 2020 at TradeWinds Island Grand Resort, St Pete Beach, Florida, United States of America.

Continuing Education Credit Hours:
SOCRA designates this educational activity for a maximum of 14.0 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 14.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Goal:
The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals. Clinical Research Monitoring is an evolving practice. The purpose of this workshop is to assist Research Site Coordinators, Quality Assurance Auditors, and CRAs/Monitors in improving their skills and their understanding of the roles and responsibilities of the Clinical Research Associate/Monitor. Although designed with all research professionals in mind, this program is ideal for Research Study Coordinators who want to improve the understanding of their responsibilities and interactions with their Clinical Research Monitors, and for Monitors/Auditors/Project Managers with 0-5 years monitoring experience who want to increase their knowledge and understanding of monitoring responsibilities.

Objective:
The goal will be accomplished through lecture and practical application facilitated by clinical research professionals with a combined industry experience of more than 20 years. Information will be presented and discussed regarding monitoring clinical trials according to FDA Regulations and International Conference on Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.

Learning Objectives: 
Upon completion of the workshop, the attendee should be able to:

• Describe the role of monitoring in clinical research
• Discuss the basic principles of Good Clinical Practice; International Conference on Harmonisation GCP guidance; Investigator’s responsibilities; Sponsor’s responsibilities; Monitor’s responsibilities; record retention; and basic requirements for conducting studies in Canada
• Describe the investigator recruitment process, identify key selection criteria, and discuss the conduct of a site selection visit
Within the historical perspective of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, discuss the objectives of regulations pertaining to Institutional Review Boards and fi nancial disclosure
• Discuss regulatory requirements and ethical considerations involved in the informed consent process as well as the informed consent document
• Describe the activities involved in study initiation including budget and contract negotiation; planning and conducting investigator meetings; investigator selection; the conduct of study initiation visits; and preparing the site for study participation
• Assess the collection and evaluation of research data for completeness, compliance, and accuracy through periodic monitoring visits; discuss reporting and follow-up correspondence
• Compare and contrast the auditing and monitoring functions; describe the objectives of auditing; describe FDA inspections and how to prepare for them; review FDA warning letters
• Discuss mechanisms to implement and assure the quality of the processes and deliverables involved in clinical research
• Describe the essential elements of planning and preparing for and conducting a site closeout visit; site follow-up; and final documents for closure
• Describe site management techniques to manage expectations, facilitate site interactions, and improve subject recruitment and study conduct
• Discuss additional investigator responsibilities and monitoring of investigator-initiated studies

Conference Details

Session Brochure : Download Session Brochure
Session url : Click here

Registration Desk

Contact No. : 215-822-8644
Email:
office@socra.org

Registration

Registration Type Last Date Price
Non-Member Conference Fee 12 Feb,2020 USD 685.00
Member Conference Fee 12 Feb,2020 USD 610.00
  • Drive Walk Transit Bicycle

Venue Address

Tradewinds Island Grand Resort
5500 Gulf Blvd
St Pete Beach, Florida, United States Of America

Official Hotel

Tradewinds Island Grand Resort,

5500 Gulf Blvd,

St Pete Beach, Florida, United States of America 33706,

+1 727-367-6461

Plan Your Travel

 
 
 
 

Please Rate this Conference

 0.0
 0.0
 0.0
 0.0
 0.0

Reviews Given by People

No Reviews available. Be the first to write a review.

Hotels Near Venue

The Ritz-Carlton Sarasota
29.78 miles from venue
Price : USD 459.00 Per Night
Art Ovation Hotel, Autograph Collection
29.78 miles from venue
Price : USD 159.00 Per Night
The Sarasota Modern, a Tribute Portfolio Hotel
29.49 miles from venue
Price : USD 191.88 Per Night
Hyatt Regency -Sarasota
29.4 miles from venue
Price : USD 199.00 Per Night
Close

Session Details

Session Topic Start Time End Time Location Speakers
Close

Workshop Details

Title Start Time End Time Workshop Fee

Subscribe to our Newsletter

x

Subscribe to our newsletter and receive updates on medical conferences, board review courses and news