Final answer:
In addition to clinical trial management, data handling, and record keeping, ICH E6 Section 5.5.3 mandates sponsors to ensure participant safety and informed consent.
FDA regulations may also require additional trials or risk management plans post-approval. IRBs critically evaluate the ethical considerations of human trials to protect subjects.
Step-by-step explanation:
ICH E6 Section 5.5 stipulates that the sponsor is responsible for the management, data handling, and record keeping of a clinical trial.
Additionally, ICH E6 Section 5.5.3 requires sponsors to ensure the protection of human subjects participating in the trials. This includes ensuring the safety of participants and obtaining fully informed consent before the start of the trial.
Sponsors may need to follow specific FDA regulations, such as conducting Phase IV trials post-approval or implementing risk management plans, including safety surveillance activities.
The FDA's Center for Drug Evaluation and Research (CDER) oversees the review of an Investigational New Drug (IND) application before human clinical trials can begin. If a therapy proves to be effective and safe during clinical trials, sponsors reach the stage where they may submit a New Drug Application (NDA).
The clinical trial process also involves other roles, such as a clinical trial coordinator who manages trial proceedings, coordinates patient schedules, maintains records, and assists in the publication of results.
Sponsors must collaborate with institutional review boards (IRBs), which review and approve the study's ethical aspects and participant safeguards.