Syllabus of CR Module is described below:
In this CR module we will cover entire lifecycle of clinical research starting drug discovery to drug development. I have 7 years of experience in clinical data management; experienced in handling multiple protocols starting from study set up with study conduct to study closeout phase for global clients in therapeutic areas like oncology, neurology, hematology, and Immunology. I will give you real time example and dataset to practice whih will help you to crack interviews and make you confidence. Post enrolling this course I will make sure you have enough knowledge and experience, same a 2+ years person in clinical research industry. Below are the topics to be covered in this module:
1- Introduction to Clinical Research & Phases in CR
2-Screening, Randomization & Blinding in Clinical Research
3-Clinical Research Design
4-ICH-GCP & Drug Regulation
5-Protocol & PubMed search
6-Responsibilities of Investigator & CRA
7-Responsibilities of Sponsor & CRO
8-Responsibilities of Ethics Committee
9- SAE Reporting
10-Data curation of Clinical trials and Health outcome data from PubMed ClinicalTrials.gov, EU registry & Clinical study report.