IB and IMPD Writing
Before a clinical trial can commence, the sponsor should submit a clinical trial application (CTA) to obtain approval from the competent authority and ethics committee.
An investigator’s brochure (IB) is one of the essential documents related to a clinical trial. It provides a summary of the available clinical and non clinical data on the investigational medicinal product (IMP) which are relevant to the study of the IMP in human subjects (Regulation (EU) No 536/2014). Its aim is to provide the investigators with information to facilitate the understanding of the rationale and the compliance with many key features of the protocol (such as dose, frequency/interval, method of administration and safety monitoring procedures).
The information should be in a concise, simple, impartial and non-promotional form that enables a clinician or potential investigator to understand it and make their own unbiased risk-benefit assessment and determine the relevance of the proposed trial. The available non-clinical and clinical information on an IMP should be adequate to support the proposed clinical trial. The Reference Safety Information (RSI) must be included. The IB must be validated and updated by the sponsor at least once a year.
When the IMP is already authorised in any EU Member State (MS), and the product is to be used in accordance with the terms of the marketing authorisation (MA), the Summary of Product Characteristics (SmPC) may be used instead of an extensive IB.
Investigational Medicinal Product Dossier
An investigational medicinal product dossier (IMPD) provides supporting scientific data on the investigational medicinal product and, where applicable, for placebos and active comparator products. A full IMPD must be submitted unless the conditions for a simplified IMPD can be justified.
A full IMPD will include quality data, summaries of non-clinical pharmacology and toxicology data and previous clinical trial and human experience data. An overall brief integrated summary must be provided that critically analyses the non-clinical and clinical data in relation to the potential risks and benefits of the proposed trial unless this information is already provided in the protocol. The format of the dossier should follow the standard headings of the Common Technical Document (CTD) and applicable European guidelines.
The information in the IMPD should be concise. Data can be presented in tabular form along with a brief narrative highlighting the main essential points. The above information may be replaced by other documentation that may be submitted alone or with a simplified IMPD.
A simplified IMPD may be submitted if information related to the IMP has been previously assessed as part of a MA in any EU MS or as part of a CTA to the concerned competent authority.