EU-CTR 536/2014 – publishing clinical trial documents through CTIS

The European Union Clinical Trial Regulation (EU CTR) 536/2014 has increased transparency requirements for sponsors conducting clinical trials in the EU. Documents within clinical trial applications (CTA) need to be redacted for protection of personal data (PPD) and commercially confidential information (CCI), and plain language summaries for protocols (recommended) and results (required) need to be written.

Krystelis runs a quarterly closed forum with sponsor representatives who are involved with managing CTAs under EU CTR. This facilitates an open exchange of ideas on challenges and experiences with EU CTR.

Krystelis EU CTR Services

Krystelis has redacted documents to support CTAs under EU-CTR 536/2014 for many sponsors. All redaction deliverables, including responses to RFIs, have been completed to support each sponsor’s submission timelines. We fully understand the regulatory requirements and can support the identification and validation of CCI through a literature search.

Krystelis also supports sponsors manage the overall submission and can submit CTAs in CTIS on their behalf.

We have developed and delivered in-depth training on EU-CTR 536/2014 to over 400 staff from several sponsors. This includes detailed training on CTIS requirements, disclosure rules, CCI decision tree, the consistent and efficient identification of CCI, European Medicines Agency’s (EMA) guidance on CCI and their rejection rules.

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EU-CTR 536/2014 – publishing clinical trial documents through CTIS

Krystelis EU CTR Services

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