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Application reassessment of clinical research involving gene therapeutics in the Netherlands Viral vectors November 2018Application reassessment of clinical study involving genetically modified virusesPart
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A clinical trial application (CTA) is submitted to regulatory authorities to seek permission to conduct a clinical trial involving human participants.
Sponsors of a clinical trial, which can include pharmaceutical companies, biotechnology firms, or academic institutions, are required to file a clinical trial application.
To fill out a clinical trial application, sponsors must provide detailed information regarding the trial design, objectives, methodology, informed consent process, and safety measures, among other requirements.
The purpose of a clinical trial application is to ensure the safety and rights of trial participants, as well as to outline the scientific validity of the proposed study.
Information that must be reported includes trial design, objectives, participant eligibility criteria, recruitment strategies, safety monitoring plans, and potential risks and benefits.
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