Clinical data sharing with researchers
Grünenthal will share clinical information, i.e., clinical study reports and clinical data from interventional clinical trials with suitably qualified scientific and medical researchers as necessary for conducting legitimate research.
Requests for Access to Clinical Study Reports
Clinical study reports refer to reports following the ICH E3 format. All protected personal data in these reports will be irreversibly masked before sharing.
Requests for access to clinical study reports (or parts thereof) will be accepted for reports for clinical trials with first protocol approval from 2003 onwards.
Requests for access must be submitted by e-mail using the Grünenthal Research Proposal Form. Requestors will be required to sign a confidentiality agreement and to provide evidence of their qualifications and experience before receiving the clinical study reports.
For the outcomes of past requests for access to Clinical Study Reports, see the list Outcomes of Requests for Access to Clinical Study Reports and Clinical Data.
Requests for Access to Clinical Data
Grünenthal will share clinical data from clinical trials conducted in patients that had first clinical study protocol approval after 15 July 2014, in support of authorized treatments in the EU and US only (unless submission is planned for only one of the two regions) and for which Grünenthal is responsible for the data. The data of these trials includes anonymized individual patient-level data only.
Further, Grünenthal will share redacted clinical study reports for clinical trials conducted in patients in support of authorized treatments in the EU and the US (unless submission is planned for only one of the two regions), that had first clinical study report approval from 2003 onwards and for which Grünenthal is responsible for the data.
See the List of Trials Accessible for Data Sharing for a list of clinical trials meeting these criteria.
There is no appeal process for rejected research proposals.
Documents and data of investigator initiated trials (IIT) will not be shared.
For clinical trials performed as part of programs together with development partners, deviations from the data sharing processes may be implemented if the following requirements are met:
- These deviations do not result in non-compliance with legal/regulatory requirements or requirements arising from data privacy laws.
- These deviations do not result in non-compliance with the EFPIA Principles for Responsible Clinical Trial Data Sharing.
All requests for access must be submitted through ClinicalStudyDataRequest.com where they will be evaluated.