FAQs: Supervise a Clinical Trial Inspection Records: CTIS Training Programme – Module 16

On 6 July 2021 the EMA published the Q&A document regarding module 16 of clinical trial inspection records.

In this document, the common questions regarding Module 16: Supervise a CT – Inspection records are listed. They are categorised into: questions regarding general information of inspection records; questions regarding the creation and submission of an inspection record; questions regarding the upload of inspection outcomes and reports; questions regarding the search, update, and cancel of inspection records; and questions regarding the roles and permissions. The specific learning objectives of this module are:

  • Remember what an inspection record is and when an MSC can create one.
  • Understand how to create and submit an inspection record.
  • Understand how to search, view, update, and cancel an inspection record.
  • Understand which user roles are involved in the inspection record process.
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