Course Overview
This course addresses clinical trial management issues and skills needed to effectively conduct clinical trials. Key course factors include investigator selection and responsibilities, clinical research protocol, data management and adverse event reporting. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.
You should expect to spend approximately 4 hours of study time to complete the course.
Course Details
2-Month Access
Course Rate: $320.00
Please have your credit card ready in order to complete registration.
Key Topics
- Sponsor Obligations
- Protocol Development and Content
- Data Management
- Adverse Event Reporting
- Investigator Responsibilities
Educational Objectives
- Identify the sponsor’s responsibilities in a clinical trial.
- Discuss key considerations when selecting a Principal Investigator.
- Describe the key elements for protocol development.
- Discuss issues central to data management in a clinical trial.
- Identify actions that must be taken when an adverse event is reported.
- Explain the FDA inspection process and identify areas of common deficiencies.
Who Should Attend
- Study site investigators
- Site monitors and auditors
- Research nurses
- Regulatory affairs associates
- Data management personnel
- Pharmacists
Continuing Education Credits
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit.
Continuing Medical Education (CME)
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Pharmacy Education (CPE)
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Initial Release Date: 06/19/2020; Expiration Date: 06/19/2023. This is a knowledge based CPE activity.