Module 5 Presentations

18/07/2024

Docs for CTN in Japan

Described in next slide

CTN Form

Protocol

English + Japanese translation

CRF sample

Japanese

Informed Consent (IC) form

Japanese

Scientific Justification

Japanese. Justify based on the available preclinical/clinical data

Investigator’s brochure (IB)

Japanese

Distribution to third parties is not allowed

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CTN Review Period

- 30-day review is required for initial clinical trials of Japanese clinical development programs for new active ingredients, new administration routes, new combinations, new indications, and new dosage and administrations. - For active ingredients already approved for a particular indication (expansion of indication, route of indication or dosage) there is two- week review period. In such cases, there are no major questions from the agency, unless there are serious safety issues. If there is no contact from the agency 2 weeks after the submission, the sponsor can start the trial (sponsor can proceed with the contracts with clinical sites).

Distribution to third parties is not allowed

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