Length of Course: Approximate time to complete this course is 1.5 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 Monitoring: Site Evaluation and Set-up
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
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, and has access to the required patient population. This course will furnish the student with a better concept of required training for CRAs (Clinical Research Associates) and will include methods through which the student will become more familiar with study documentation. Described in detail, with particular attention paid to the site qualification visit, will be the procedures needed before an investigational site can be initiated. The procedures and responsibilities associated with preparation and conducting of initiation visits will also be discussed at length.
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. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certificate of completion is immediately available.
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 offers proven methods that can help you, your company, and your colleagues to further your education or simply refresh your existing knowledge. Many of our courses bring to light important changes which have recently taken effect and been applied in various areas of the healthcare, pharmaceutical, and clinical research industries.
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 Monitoring: Site Evaluation and Set-up course is found in the following professional certification program(s):
This session briefly describes the legislative guidelines that apply to the conduct of clinical trials.
CRA training: This session outlines the training requirements for site monitoring according to International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. The study documentation with which a CRA should be familiar prior to commencing work on a clinical trial is also discussed.
Site qualification visit: This session outlines the preparation, conduct and follow-up of a site qualification visit.
Groundwork: This short session provides an overview of the site related activities which will occur between the site qualification and initiation visit. Although a CRA might not be actively involved, groundwork activities are integral to successful site initiation. Initiation visit This session outlines the preparation, conduct and follow-up of an initiation visit.
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:
--Describe the evaluation and qualification process at an investigational site.
--Identify the study documentation required prior to commencing work on a clinical trial.
--Describe what is required of a study site to conduct a clinical trial successfully.
--Outline the procedures to be conducted prior to the initiation of a study site.
--Describe the measures taken during site evaluation, set-up and initiation to ensure that the conduct of clinical trials complies with the protocol.
--Describe the initiation process at an investigational site.
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.