Clinical trials involving medicinal products
For clinical trials involving IMP's (investigational medicinal products) specific information is needed in the research protocol and also in the MREC standard research file for submission.
If the investigational product is a medicine or placebo, Amsterdam UMC researchers must always get in touch with the Kenniscentrum Geneesmiddelenonderzoek to arrange for necessary agreements and documentation. Make use of their application form.
The Kenniscentrum Geneesmiddelenonderzoek also offers a full range of support services for clinical trials, such as:
- pharmacological advice when setting up clinical trials and drawing up research protocols;
- drafting the necessary documentation for medicinal products in clinical trials;
- taking care of storing, distribution and checking correct usage of medications before, during and after the study (drug accountability at the study level);
- packaging, labelling and importing medicines;
- professional advice when developing medicinal products for clinical trials, such as the right method of administering the drug or the composition of the research product suitable to the design of the study.
If the research product is a medicine that is already on the market (or is already registered), you can use the Summary of Product Characteristics (SPC text) from the product leaflet to inform the MREC about the medicine.
If the research product is not yet registered, or if a registered product will be used for a different medical indication or administered a different way than that for which it has been registered, then you must supply an Investigator’s Brochure (IB) and/or an Investigational Medicinal Product Dossier (IMPD). The Kenniscentrum Geneesmiddelenonderzoek can help you with this.
Investigator’s Brochure (IB)
The main purpose of the Investigator’s Brochure (IB) is to provide insight into the possible health risks and side effects posed by the research product, and which measures (including preventive measures) are necessary to take when studying the effects of the product in human subjects. These insights must be based on accessible physical, chemical, pharmaceutical, pharmacological, toxicological and clinical information about the research product.
Usually, an IB is drawn up by the manufacturer who developed the product.
For registered products whose pharmacological properties are known to the investigators, a Summary of Product Characteristics (SPC text) may suffice, on the condition that it contains all clinical and preclinical information that the investigator needs.
The website of the Medicines Evaluation Board has the SPC text for many medicinal products.
Investigational Medicinal Product Dossier (IMPD)
For use of non-registered products in research, you must have an IMPD. An IMPD has specifications about the quality, production and testing of the product for the study. The IMPD also contains a summary of the details from all clinical and non-clinical studies. For that section you can make reference to the Investigator’s Brochure.
If you will be conducting a trial with a non-registered medicine, contact the Kenniscentrum Geneesmiddelenonderzoek in advance.