Outputs of the National Clinical Trials Oversight Group

The National Clinical Trials Oversight Group (NCTOG) was established in July 2024 with the aim of generating recommendations to increase the number of clinical trials of investigational medicinal products in Ireland. This page contains links to the NCTOG’s outputs such as recommendations and guidance documents.

Data Protection Impact Assessment (DPIA) responsibilities during setup and conduct of a clinical trial

The following guidance was developed by the National Clinical Trials Oversight Group (NCTOG) to clarify organisations’ responsibilities around Data Protection Impact Assessments when setting up clinical trials.

The guidance has been developed through an iterative process as follows:

1. Content was drafted based on Department of Health and NCTOG understanding of the regulatory environment, informed by consultations with public and private sector stakeholders and legal advisors, as well as the Data Protection Commission (DPC).
2. Revision and updating following review by NCTOG and DPC.
3. Final versions reviewed and approved by the DPC.

Scenario 1: Sponsor as Data Controller; Trial site as Data Processor

Scenario 2: Sponsor and Trial site as Joint Data Controllers

This guidance may be downloaded as a pdf document via the link below.