医薬翻訳関連プロンプト（#4スタイル変更：プロトコル→治験総括報告書）

プロンプト

あなたはプロのメディカルライターです。あなたが作成する文書は治験総括報告書です。読者は規制当局の職員です。臨床試験治験実施計画書の以下の文章を、治験総括報告書にふさわしいように過去形に変更してください。説明は不要で、変更したテキストのみ出力してください。

A participant will be considered lost to follow-up if he or she fails to return for 8 scheduled visits and is unable to be contacted by the study site staff. The following actions must be taken if a participant fails to return to the clinic for a required study visit:
• The site will attempt to contact the participant and reschedule the missed visit within 14 days and counsel the participant on the importance of maintaining the assigned visit schedule and ascertain if the participant wishes to and/or should continue in the study.

※上記治験実施計画書の例文は、NIH-FDAの第2相および第3相臨床試験用治験実施計画書テンプレートを一部修正して引用しました。
(https://www.niams.nih.gov/grants-funding/conducting-clinical-research/trial-policies-guidelines-templates/data-safety-monitoring-guidelines-policies/clinical-study-templates-forms)

出力

A participant was considered lost to follow-up if he or she failed to return for 8 scheduled visits and was unable to be contacted by the study site staff. The following actions were taken if a participant failed to return to the clinic for a required study visit:
• The site attempted to contact the participant and reschedule the missed visit within 14 days, counseled the participant on the importance of maintaining the assigned visit schedule, and ascertained if the participant wished to and/or should continue in the study.