
Clinical research determines safety and efficacy of medications, devices, and diagnostic products for human use. It includes drug trials, genetic and epidemiological studies, and four-phase drug development.
Learn how the clinical trial protocol guides preclinical design to regulatory approval, detailing amendments, objectives, design, IND and FDA review, eligibility criteria, endpoints, blinding, and adverse events.
Explains the IND as the sponsor's regulatory application with preclinical animal studies, pharmacology, toxicology, and manufacturing data, guiding phase 1–3 trials toward NDA marketing approval.
Learn how the ICH GCP harmonizes ethical and scientific standards for clinical trials, rooted in the Declaration of Helsinki, guided by ethics committees, informed consent, protocols, data integrity, GMP.
Understand the clinical research associate's role as the sponsor’s communication bridge, conducting site selection, initiation, routine monitoring, and close-out to ensure protocol compliance and patient safety.
Ethics committee independently reviews all proposals to protect participants and ensure informed consent, upholding the Declaration of Helsinki with a multidisciplinary five-member composition.
Learn how informed consent upholds ethics, autonomy, justice, and participant welfare in clinical trials. Examine the consent process, screening, and inclusion and exclusion criteria to enable informed decisions.
This program will help participants to learn Clinical Trial Process/ Clinical Operations. Program starts with an Introduction followed by Phases in Clinical Trial Process, ICH- GCP guidelines, Stakeholders in Clinical Research and their responsibilities in Clinical Trial. Program gives and overview rather an in-depth details. If you are looking to get first hand information about clinical research, this program can be the right fit.