Length of Course: Approximate time to complete this course is 4 hour(s).
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
Training Program: GCP: Clinical Trial Preparation and Design
Training Provided By: BioPharma Institute
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.
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: Clinical Trial Preparation and Design course is found in the following professional certification program(s):
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.
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.
All Courses in the Clinical Trials Management and Monitoring Catalog:
|GCP: ICH Good Clinical Practice (ICH-GCP): Many regulatory changes are happening in the pharmaceutical industry. Those who are particularly affected are individuals involved in research. When carrying out research duties, there is always the risk of bre ... Learn more|
|GCP: Clinical Trial Preparation and Design: 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 ... Learn more|
|GCP: Clinical Trials and Drug Development: This online course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials is outlined. The ... Learn more|
|GCP: Clinical Trial Monitoring: Site Evaluation and Set-up: Site evaluation and the set-up's purpose is to ensure that the site is fully prepared for the conduct of the clinical trial, facilitates to conduct the study, has adequate time and appropriately qualified staff ... Learn more|
|GCP: Clinical Trial Monitoring - Documentation and Closure: Once the initiation of a trial begins, the CRA (clinical research associate) has a crucial role which is to monitor the conduct of the trial, as well as the recorded data's integrity. This online course will fa ... Learn more|
|GCP: Preparing for an Audit or Inspection: In order to ensure compliance with GCP (Good Clinical Practice), clinical trial sites of investigators and sponsors are subject to rigorous inspection by regulatory agencies. In this course, United States and E ... Learn more|
|GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA: The IND (Investigational New Drug) Application is a submission through which the sponsor seeks approval from the FDA (Food And Drug Administration) to conduct clinical studies with an investigational drug. This ... Learn more|
|GCP: How to Obtain Approval to Conduct Clinical Trials in the EU: Before each phase of clinical development, approval must be sought and gained for any sponsor desiring to conduct investigational drug clinical studies in the European Union. This online course enlightens regul ... Learn more|
Online Training: The Benefits of eLearning
- 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
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
- Corporate LMS compatibility: 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 could 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.