Research Roadmap

For clinical trials involving medicinal products, the European Clinical Trial Regulation (CTR) is applicable. Specific information is required in both the study protocol and the standard research file for submission to the Medical Research Ethics Committee (MREC).

What is a medicinal product?

A medicinal product is defined as:

• Any substance or combination of substances presented for treating or preventing disease in human beings;
• Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.

Kenniscentrum Geneesmiddelenonderzoek

If the medicinal product is a medicine or placebo, Amsterdam UMC researchers must contact the Kenniscentrum Geneesmiddelenonderzoek to arrange necessary agreements and documentation via the designated application form.

The Kenniscentrum Geneesmiddelenonderzoek provides comprehensive support services for clinical trials, such as:

• Pharmacological advice for clinical trial design and study protocols;
• Drafting necessary documentation for medicinal products in clinical trials;
• Storage, distribution and drug accountability (at study level) before, during and after the study;
• Packaging, labelling and importing medicines;
• Professional advice when developing medicinal products for clinical trials, such as drug administration methods and product composition suitable for the study design.

If the medicinal product is already on the market or registered, the Summary of Product Characteristics (SPC) from the product leaflet is sufficient to submit to the MREC.

If the medicinal product is not yet registered or will be used for a different medical indication or administered in a different way than its registration, an Investigator’s Brochure (IB) and/or an Investigational Medicinal Product Dossier (IMPD) must be submitted to the MREC. The Kenniscentrum Geneesmiddelenonderzoek can help researchers with these documents.

Investigator’s Brochure (IB)

The IB provides insight into potential health risks, side effects, and necessary (preventative) measures when administering the medicinal product to participants. It must be based on the product's physical, chemical, pharmaceutical, pharmacological, toxicological and clinical data.

Manufacturers typically prepare the IB for their products. However, for registered medicinal products with well-known pharmacological properties, a SPC may suffice - provided it contains all clinical and preclinical data that the researcher needs.

The website of the Medicines Evaluation Board contains SPCs for many medicinal products.

Investigational Medicinal Product Dossier (IMPD)

For clinical trials involving non-registered medicinal products, an IMPD is required. This document outlines the quality, production and testing specifications of the product for the study. The IMPD also contains a summary of clinical and non-clinical study data, which may reference the IB where applicable.

Researchers preparing to conduct a clinical trial with a non-registered medicinal product must contact the Kenniscentrum Geneesmiddelenonderzoek in advance.