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.
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.
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.
Monitoring visit: This session outlines the preparation, conduct and follow-up of a routine monitoring visit.
CRF review: Case Report Forms are crucial in conducting a successful clinical trial. This session discusses the monitoring and review of CRFs.
Source document verification: Inadequate understanding of the process involved in source document verification results in the procedure being ineffective. This session explains the importance of source document verification in clinical trials.
Essential documents: Collection and review The ICH GCP guideline identifies a minimum list of essential documents that are required throughout a trial, including specific details of where each document should be filed during the study, and their purpose. This session summarizes these documents. The contents of the Trial Master File and Investigator Site File are also described.
Close-out visit: This session outlines the preparation, conduct and follow-up of a close-out visit. Sponsor site audits This session will focus on sponsor site audits. The purpose of sponsor audits will be described, as well as the role of the CRA and common audit findings.
Fraud and scientific misconduct: CRAs are sometimes faced with serious situations, namely errors, misconduct and fraud. This session will focus primarily on the CRA's role in these unfortunate events.
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 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.
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.