Important Documents For Researchers

The CRDO supports researchers and to help researchers navigate through the setting up and management of clinical research, resources and advice are available in this area of the website.


GCP guidelines states there should be procedures in place to ensure that clinical trials are conducted, documented and data generated in compliance with the protocol, GCP and the applicable regulatory requirements. 

SOP's will be uploaded to the website soon

2. Policies (e.g. Quality Policy)

Policies will be up uploaded to the website soon

3. Data Protection

Data Protection is the means by which the privacy rights of individuals are safeguarded in relation to the collecting and processing of their personal data. DPIAs are important tools for negating risk, and for demonstrating compliance with the GDPR

A Data Protection Impact Assessment (DPIA) describes a process designed to identify risks arising out of the processing of personal data and to minimise these risks as far and as early as possible.

A DPIA is required to be completed and approved by the applicable DPO/DDPO for each clinical study, prior to the study being approved or opened for recruitment. See links below for HSE and NUIG DPIA/PIA templates.   

The HSE and NUIG approved DPIAs for clinical research data that adheres to the clinical research quality system are located here on Sharepoint. Please refer to the governing SOP on how to use these documents.

4. HPRA Approval

The Health Products Regulatory Authority (HPRA), is Ireland’s competent authority and the state body responsible for regulating medicines, medical devices and other health products.

The decision tree in Annex 1 can be used to identify whether a trial is an interventional/regulated clinical trial in the sense of the directive/regulations:


Please refer to Page 17 of this document

HPRA Publications & Forms are available here

5. EC/NREC Approval

All clinical trial/Investigations must also be pre-approved by an Ethics Committee.  Please click here for submission deadline dates, meeting dates and contact details of the Galway Clinical Research Ethics Committee.

All interventional, regulated clinical trials and investigations must be pre-approved by the National Research Ethics Committee. Please click here for all details/forms and submission dates.