Research Roadmap

For clinical trials involving medicinal products, the European Clinical Trial Regulation (CTR) is applicable. Specific information is required in both the research 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.

Clinical Trial Pharmacy

If your study involves a medicinal product (including placebos), Amsterdam UMC researchers must contact the Clinical Trial Pharmacy (in Dutch: subdepartment Klinisch Geneesmiddelenonderzoek, KGO) via the official application form to arrange all required documentation and pharmacy support.

KGO provides comprehensive services for clinical trials, including:

• Pharmacological advice for trial design and research protocols;
• Drafting required documentation;
• Encapsulation, packaging, and labeling of investigational medicinal products (GMP-compliant);
• Storage, distribution and drug accountability;
• Support during monitoring, audits, and study close-out;
• Preliminary pharmacy budgets for funding applications (request at least 1 month in advance).

If the investigational medicinal product is authorized and used according to its label, the Summary of Product Characteristics (SmPC) is sufficient for submission to the MREC. If not, an Investigator’s Brochure (IB) and/or an Investigational Medicinal Product Dossier (IMPD) is required. KGO can assist in preparing 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 SmPC may suffice - provided it contains all clinical and preclinical data that the researcher needs.

The website of the Medicines Evaluation Board contains SmPCs 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 KGO in advance.