Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Danish GCP Inspectors Get Full Access To Electronic Patient Data

Executive Summary

Changes to the Danish clinical trials legislation will ensure that GCP inspectors, who were earlier denied direct access with their own username and password to electronic health records of trial subjects, now have full access to this information while inspecting studies.

You may also be interested in...



Phase I Studies Drive 16% Rise In Danish Clinical Trial Applications

Clinical trial applications in Denmark rose by just under 16% in 2015, driven partly by a doubling in the number of Phase I studies, which the medicines agency attributes to the work of a new public-private partnership aimed at boosting Denmark’s attractiveness as a location for early-phase trials.

Global Pharma Guidance Tracker – March 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

EU Regulators Explain How To Ensure Transitioned Trials Align With CTR

Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS118971

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel