|Duration: 2 hours (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.
Training Program: GCP: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. Once a trial is initiated, the crucial role of the clinical research associate (CRA) is to monitor the conduct of the trial and the integrity of the data recorded. This online course introduces areas such as monitoring of case report forms (CRFs), source document verification and the review and maintenance of essential documents. The responsibilities and procedures associated with monitoring processes and close-out visits are also explained.
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:
The GCP: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure course is found in the following professional certification program(s):
Overview: This session briefly describes the legislative guidelines used to conduct clinical trials.
Students completing this course should be able to: Outline the monitoring activities conducted on a site visit. Identify the requirements for accurate and consistent CRF completion by site staff. Define the CRA’s responsibilities for the monitoring and review of CRFs. Define source documents and the procedures for source document verification. Identify the essential documents which must be available prior to the commencement of a clinical trial at each investigational site, during the conduct of a clinical trial, and after completion or termination of a clinical trial to comply with ICH Good Clinical Practice (GCP) guidelines. Describe the procedures to be conducted to close a trial at each investigational site, when the requirements of the protocol have been fulfilled, or if continuation of the trial is considered inappropriate. Explain the importance of sponsor site audits. Summarize the role of the monitor in preparation for a site audit. Identify the responsibilities of the CRA in identifying and reporting scientific misconduct.
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.