Relevant links

Below are the most relevant links related to conducting clinical research in The Netherlands as well as outside The Netherlands.

International resources

1. European Medicines Agency
https://www.ema.europa.eu/en

2. European Commission Directives & Regulations
https://ec.europa.eu/health/human-use/clinical-trials_en

3. EudraLex - Volume 10 Clinical trials (GCP) guidelines
https://ec.europa.eu/health/documents/eudralex/vol-10_en

4. EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
https://ec.europa.eu/health/documents/eudralex/vol-4_en

5. ICH official website
https://www.ich.org/

6. ICH Q9: Quality Risk Management
https://www.ema.europa.eu/en/ich-q9-quality-risk-management

7. U.S. Food & Drug Administration
https://www.fda.gov/

8. The Association of Clinical Research Professionals
https://acrpnet.org/

9. TransCelerate BioPharma Inc.
https://transceleratebiopharmainc.com/

10. Research Quality Association (RQA, UK)
https://www.therqa.com/

11. WHO International Clinical Trials Registry Platform (ICTRP)
https://www.who.int/ictrp/en/

12. Clinical Trials Registry
https://www.clinicaltrials.gov/

National (Dutch) resources

1. General Information on Applicable Laws and Acts in The Netherlands
https://www.rijksoverheid.nl/

2. Inspectie Gezondheidszorg en Jeugd
https://www.igj.nl/

3. Centrale Comissie Mensgebonden Onderzoek (CCMO)
https://www.ccmo.nl/

4. Autoriteit Persoonsgegevens
https://autoriteitpersoonsgegevens.nl/

5. College ter beoordeling van Geneesmiddelen
https://www.cbg-meb.nl/

6. Nederlandse Vereniging voor Klinische Chemie en Laboratoriumgeneeskunde
https://www.nvkc.nl/kwaliteitrichtlijnen/cckl

7. Dutch Association of Research Quality Assurance (DARQA)
https://www.darqa.org/index.php

8. GCP central
https://gcpcentral.com/

9. Nederlands Trial Register
https://www.trialregister.nl/trialreg/index.asp

10. Nederlandse Vereniging voor Farmaceutische Geneeskunde
https://www.nvfg.nl/

11. NFU Guidelines
https://www.nfu.nl/