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. Many documents included within clinical trial applications (CTA) need to be redacted for PPD and CCI as part of the initial submission process.
Documents requiring redaction for CTAs under EU-CTR
These include, but are not limited to, protocols, protocol synopses and protocol amendments, IMPDs, DSMB charters, scientific advice, PIP decisions, insurance documents, investigator’s brochures, informed consent documents, investigators’ CVs, site suitability documents.
Krystelis EU CTR Services
Krystelis has already successfully completed redaction of documents to support CTAs under EU-CTR 536/2014 for several sponsors. All redaction deliverables 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.
We have also developed and delivered in depth training on aspects of EU-CTR 536/2014 for sponsor teams. This includes in depth training to support the efficient and consistent identification of CCI.
A VP of Clinical Operations we recently worked with said: “Working with Krystelis was really very easy and I will recommend your team to anyone needing redaction support.”
Get in touch with us for your EU CTR-related requirements…
Contact us at: [email protected]
