Clinical Study Monitor certificate program primarily focuses on the regulatory and scientific rationale of designing, conducting, monitoring and successfully completing a clinical trial. The students will learn how to create documents, especially forms. Critical issues are to be considered, while designing a study protocol for clinical trial.
This program is designed to provide training in ICH / GCP guidelines, clinical trial monitoring, investigation site coordination, knowledge and understanding of FDA regulations and finally the knowledge how to apply the principles and practices for designing and conducting a clinical research program. Upon completion of this training program and passing the related tests, the student will demonstrate a proficiency in both theoretical as well as practical aspect of clinical study monitor, that will attest to their qualification ad expertise. Graduates will be able to pass the national exam as SOCRA /ACRP, so that any pharmaceutical company/CRO, hospital, diagnostic center in the US territory can formally accept them for a career.
Course Duration: 90 Hours