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This is intended for Applicants to notify the South African Health Products Regulatory Authority (SAHARA) of intention to undertake a phase IV clinical study of an approved medication within its approved
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A clinical trials application (CTA) is a formal request submitted to regulatory authorities to obtain approval to conduct a clinical trial on human subjects. It includes details about the trial's objectives, methodology, and the investigational product.
Typically, the sponsor of the clinical trial, which can be a pharmaceutical company, biotechnology firm, or academic institution, is required to file a clinical trials application.
To fill out a clinical trials application, sponsors must complete specific forms provided by regulatory authorities, detailing trial information, including the study design, risk assessments, participant information, and funding sources.
The purpose of a clinical trials application is to provide regulatory bodies with the necessary information to evaluate the safety, efficacy, and ethical considerations of a proposed trial before it can commence.
Information required in a clinical trials application includes trial design, eligibility criteria for participants, investigational products, monitoring plans, and informed consent procedures.
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