In an effort to clear up sponsor confusion, the European Medicines Agency (EMA) has issued a new question-and-answer document related to the Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR) that sponsors are now required to use and adhere to.

The newly issued guidance contains 82 questions and answers on a number of topics based on inquiries from sponsor groups, such as the Association of Clinical Research Organizations (ACRO), the European Federation of Pharmaceutical Industries (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and the European Clinical Research Organization Federation (EUCROF). Topics include:

• Clinical trial applications under the CTR;
• CTIS implementation;
• The General Data Protection Regulation (GDPR);
• Master data sources;
• Safety event reporting;
• Transparency;
• Training and support;
• The CTIS transition period; and
• User management.

For example, one of the transparency questions asks what information needs to be provided when uploading a document and how document properties are handled in CTIS.

The EMA clarifies that sponsors should consider that, because the “for publication” versions of documents will be shared with the public, they are responsible for adhering to GDPR to protect personal data when necessary. Further, the agency explains that any personal information included in the document content or properties falls under protection of personal data rules.

The guidance also includes a references section that links to a number of documents, training resources, services and other items for navigating the CTIS and CTR.

Read the full Q&A guidance here: https://bit.ly/3kvaDhs.