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ICH E11 1334 12 is a regulatory document related to clinical trials.
The pharmaceutical companies or organizations conducting clinical trials are typically required to file ICH E11 1334 12.
ICH E11 1334 12 should be filled out following the specific guidelines provided by the regulatory authorities.
The purpose of ICH E11 1334 12 is to ensure the proper conduct and reporting of clinical trials in accordance with regulatory standards.
ICH E11 1334 12 typically requires information related to the protocol of the clinical trial, patient data, adverse events, and overall trial results.
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