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Home » GCP: An Introduction to Clinical Trial Preparation and Design

GCP: An Introduction to Clinical Trial Preparation and Design (GCP02)

Certification Training
Duration: 2 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: GCP: An Introduction to Clinical Trial Preparation and Design
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute ReviewsWorldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. To maintain profitability, it is essential to minimize the spiraling costs of research. Therefore, companies need to introduce measures to improve the efficiency and effectiveness of the clinical trial process. From a scientific perspective it is vital to obtain sufficient and accurate data.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The GCP: An Introduction to Clinical Trial Preparation and Design course is found in the following professional certification program(s):


Professional Designation in Clinical Trials Management: For Clinical Research Associates, Project Managers, and Clinical Managers. ... Learn more

Professional Designation in Good Clinical Practice: For Clinical Research Associates, Project Managers, and Clinical Managers. ... Learn more

COURSE OUTLINE:


Overview: This session briefly describes the relevant legal documents and guidelines relating to clinical trial design.

Clinical trials in drug development: The crucial role of clinical trials in the drug development cycle is examined. Regulatory requirements and financial pressures, and their interaction with trial design, are discussed.

Protocol design: This session provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.

Clinical trial preparation: This session provides an overview of the role of the sponsor in supporting and improving quality in the conduct of clinical trials.

Endpoints: This session focuses on clinical trial endpoints. The purpose of endpoints and the types are discussed in this part.

Statistical elements: This session covers the role of statistics in clinical trial design and analysis, as acknowledged in the International Conference on Harmonization (ICH) guideline for Good Clinical Practice (GCP).

Study design: This session provides an overview of the main types of study design.

Data capture and management: This session describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.

Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points.

COURSE OBJECTIVES:


Students completing this course should be able to: Outline the role of clinical trial design in clinical research. Identify the relevant legal documents and guidelines relating to clinical trial design. Recognize the essential statistical components for clinical trial design and how these affect design choice. Define the general principles and concepts for trial design, and describe the implications of design choice on regulatory acceptance. Identify the strategies to improve data capture and management. Describe how electronic data capture can improve clinical trial development.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization

For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.

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