Protocol requirements and documentation in clinical trials
報名期間:從 即日起 到 無限期
上課期間:從 2022-01-01 到 2030-12-31
學 分 數 :1



Most of clinical trial staff may have questions as below: - What the mandatory requirements in protocol if you need to draft the protocol for EC/RA submission? - Which documents do you need to keep once you conduct the clinical research? The arm for this training is to give the concept for all attendees regarding to protocol contents and essential documents of clinical research per ICH-GCP. This training is suitable for new staff to conduct clinical trials, the investigator who needs to draft the study protocol or experienced members to refresh the knowledge of related requirements. Then it will be helped you to reduce the EC/RA submission cycle time for your studies and avoid any critical or major findings during the inspection or audit of your studies. The objectives for this course are including as following agenda: a. Definition of Protocol and Protocol Amendment(s); b. Contents of Protocol; c. Concept for Essential Documents
台灣愛康恩研究有限公司 林姿妙 臨床研究管理總監資深/臨床研究經理
  • 前測
  • 課程
  • 後測
  • 問卷-Protocol requirements and documentation in clinical trials


醫療器材 GCP查核準備與經驗分享