D1. Investigator’s Brochure (IB)

Evaluation

The IB must be evaluated at least annually and revised where needed. More frequent revision may be required depending on the developmental stage and availability of new information. Relevant new information may be of such importance, however, that it must be submitted to the WMO reviewing committee and the competent authority before it is integrated into a revised IB, as required by GCP rules. Therefore, the IB may not be older than 1 year, unless annual evaluation has shown revision was not required. It must also be clear that the IB was evaluated less than one year ago.

SUSARs

Additionally, all relevant information regarding the safety of the product that has not yet been included in the IB must be submitted. At this time, this information is limited to a line- listing of the SUSARs that have occurred. This line listing must be accompanied by a review by the sponsor which clearly indicates whether this information has any consequences for the safety of the research subjects. If each SUSAR has been evaluated individually by the sponsor, a declaration must be given in the cover letter indicating whether these SUSARs have any consequences for the human subjects participating in the study in question.

Authorised products

An extensive IB is not always required for authorised products for which the pharmacological aspects are known to the doctor/investigators. An SPC (summary of product characteristics) may suffice, as long as it contains all information relevant to the investigator. This exception does not apply to authorised products used in a research setting for uses other than the authorised use or with another route of administration.