About the Course
Clinical Research Associate (CRA) – 80 hours
This course is designed and offered to the professionals interested to serve as Clinical Research Associates in clinical trials. Clinical Research Associates work under the supervision of Principal Investigator to organize, coordinate and administer clinical research trials. The course includes range of topics such as; foundations of clinical research, research design and data management, ethics, good clinical practices(GCP), site selection and site initiation, patient recruitment, drug development processes, medical terminology, and legal and regulatory compliance. The format will be lecture based but designed to engage in case based discussion and active participation. Students will be assigned a drug development topic which they will research and present during the last session of the course. Students will practice with documentation and data forms.
At the end of the course, students will be able to :
- Discuss the role the CRA plays in the drug development process;
- State the “letter” and the “spirit” of FDA regulations, and ethical considerations pertinent to conducting clinical trials;
- Select qualified investigators;
- Prepare for and conduct Site Selection/Qualification, Site Initiation, Routine Monitoring, and Study Close out Visits;
- Manage and report adverse events (AEs); and
- List study documentation requirements and standards for collecting and reporting clinical trial data.
There are 10 modules, each broken into two parts and covered in 8 contact hours, totaling 80 hours.
|Module 1||Overview of Drug Development, FDA & ICH GCP||8 Hours|
|Module 2||The Clinical Research Team: Roles & Responsibilities||8 Hours|
|Module 3||The Site Selection Process & Site Qualification Visits||8 Hours|
|Module 4||IRB/IECs & The Approval Process||8 Hours|
|Module 5||Study Subject Recruitment, and the Informed Consent Document & Process||8 Hours|
|Module 6||Investigator’s,Meetings & Study Initiation Visits||8 Hours|
|Module 7||Managing & Reporting Adverse Events||8 Hours|
|Module 8||Investigational Product Accountability & Essential Documents||8 Hours|
|Module 9||Routine Monitoring Visits & Source Data Verification||8 Hours|
|Module 10||Clinical Data Management Overview, Trip Reports and,Study Close-out Visits
-Monitoring Simulation Exercise