Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact — you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates.
In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided. NOTE: This course is for individual registrants only and does not allow for group training. The breadth of knowledge and experience of the trainers was impressive.
The overview of quality systems and regulatory expectations will surely have a place in my daily monitoring activities. It gave me a true guideline as I manage expectations of all parties and what to look out for during visits, as well as how to document findings in a responsible, accurate way. Thank you so much. I plan to make use of all the monitoring tools provided to achieve success and utilize EDC for ease of CRF collection.
When in doubt, I will always refer back to modules for guidance. Great course, thanks! Click here for complete trainer biographies. Clinical Research Associate. Learning: hours online and self-paced, 8 Modules, Final Exam. Duration: weeks. Prerequisites: ideally life science education or first work experience. More than a Course. A Flexible Online Setup Our setup enables you to complete this program either next to a full-time job or in a focused effort.
Access to all Academy Services. Global Clinical Research Jobs. Course Program. You will complete each module by: taking your e-learning submitting your assignment work reviewing pre-recorded webinars completing your module test.
Selecting and Initiating Clinical Trial Sites. Monitoring and Closing Clinical Trial Sites. Investigational Medicinal Product Management. Data Management for Clinical Research Associates. The streamlined course content, challenging homework assignments, and live instruction create a training format that I found engaging, thorough, and dynamic. As a result of completing this program, I feel much more prepared to succeed as a clinical research professional. Start today.
Your expert instructors. Eric Klaver. Gabriele Disselhoff. The importance of good documentation practice needs to be stressed to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This module provides an overview of clinical operations in the study start-up phase of a clinical trial. From final protocol to first patient visit, a Study Start-Up Team must be formed, vendors and sites selected and activated, processes established for data collection and reporting, and regulatory approvals obtained.
This module provides focused training on areas such as feasibility assessment, site selection, pre-study visit, site initiation, subject recruitment and retention, trial master file TMF and clinical trials budgeting. Study monitors must have a thorough understanding of the Code of Federal Regulations, local laws, guidelines and their assigned study protocols.
Monitors serve both as communication conduits between sites and sponsors, and as managers for individual research projects. This module provides comprehensive training in areas such as routine site monitoring, CRF review and source data verification, drug accountability and compliance, site close out, writing effective monitoring reports and follow-up visit letters, and document archival and maintenance.
One of the most important responsibilities of the CRA is to ensure that clinical investigators are fully aware of, and are in compliance with their responsibilities for adverse event reporting. To achieve this, the CRA must often teach the adverse event reporting requirements to investigators. As a result, the CRA must be knowledgeable about both the regulatory and sponsor-specific requirements for reporting serious and non- serious adverse events in clinical trials.
This includes the correct use and completion of the adverse event forms, and definitions and terms of reporting adverse events that may extend beyond the regulatory requirements. This module provides training on documenting and reporting adverse and serious adverse events in clinical trials. Certification Examination:. Proctored exams are a required component of the certification programs at CRS.
Scheduling of examinations with proctorU will not incur any additional cost unless the exam is scheduled within 3 days of the date of scheduling. The certification examination will be of 2 hour duration. ProctorU allows individuals all over the world to take their exams online while ensuring academic integrity for the institution. ProctorU uses a three-step process to replicate the face-to-face proctoring experience over the Internet.
Through this process, proctors can see the student, observe their computers, and know whom they are monitoring. ProctorU does this while adhering to the highest accreditation standards in the industry.
ProctorU is a pioneer in the industry and serves close to partnership institutions including Northwestern University, the University of Florida and the University of Illinois. You can find more information on ProctorU here.
0コメント