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Tuesday, December 11, 2018
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GCP: Clinical Trial Preparation and Design (GCP002)

Certification Training CPD Accredited TrainingCredits: 4 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $145.00

BioPharma Institute LogoTraining Program: GCP: 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.

Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical trials. It is essential to minimize researches’ spiraling costs in order to maintain profitability. So companies need to create measures to improve the effectiveness and efficiency of the process of clinical trial. It is vital, from a scientific perspective, to obtain accurate and sufficient data.

After a general overview, this course topics include: data capture and management, study design, statistical elements, endpoints, clinical trial preparation, protocol design, clinical trials in drug development, and a key point summary at the end.

The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 75% or better is required to immediately launch a certificate of completion in a PDF format. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at BioPharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. The BioPharma Institute can help improve your company’s overall quality of service, maintain training records, and assist in the education of your employees through its automated tracking systems and advanced e-learning training techniques. We have worked with thousands of corporations abroad and throughout the United States. See what the BioPharma Institute can do for you and your company.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


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.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, 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 training: 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
  • 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
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


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


Clinical Trials Management (US & EU) Professional Certification Program: This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates and coordinators with the desire to grow … Learn more

Obtaining Approval for Clinical Trials in US & EU Professional Certification Program: Clinical Trials Management (US & EU) Professional Certification Assures Employee Compliance of GCP Standards This professional certification program is designed for regulatory affairs managers, project 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.


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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