welcome back to the gcp mindset channel as you may know the essential documents are the study protocol watch your video about the study protocol here the investigator's brochure and finally the case report form today we will take a deeper look at the investigator's brochure more after the intro [Music] the investigator's brochure is one of the essential documents but what is it about the investigator's brochure contains a title page with the current version number a summary an introduction and a complete overview of physical chemical and pharmaceutical properties and basic approaches please note that all investigators must always use the latest version of the investigator's brochure to obtain information so stay up to date if you work as an investigator it's absolutely essential the investigator's brochure contains an introduction a description of non-clinical pharmacology and product metabolism in animals as well as toxicology the investigator needs to examine this information precisely especially in early phases for example a phase one clinical trial because there is mostly only very little information and experience of human application if the drug or investigational product has already been tested on humans you will of course also find information in the investigator's brochure on pharmacokinetics and on product metabolism in humans as well as information on safety the mode of use and marketing experience plus a data summary and a manual for investigators the longer the drug has already been tested the more information about it can be found in the investigator's brochure guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous human experience and on the pharmacology of the investigational product the purpose of the investigator's brochure is to provide the investigator with all available scientific background information on the study drug against the backdrop of this information the underlying causalities between adverse events or new side effects can be evaluated more effectively and safely therefore it is vital that all people at the trial site making medical decisions are familiar with the content of the investigator's brochure in order that they are able to make sensible medical decisions as a study nurse for example you should make sure that the monitor does not just file the current investigator's brochure to the investigator site file but rather gets himself or herself informed about any innovations moreover the investigators of your site should confirm the receipt of this relevant information signing the ib receipt form as part of its guidance on good clinical practice or gcp the international conference on harmonization or ich has prepared a detailed guidance for the contents of the ib in the european union japan and the united states and finally who's responsible for the ib the sponsor is responsible for keeping the information in the ib up to date the ib should be reviewed annually and must be updated when any new or important information becomes available such as when a drug has received marketing approval and can be prescribed for use commercially hey thanks for watching next time we will talk about the third essential document the crf or the case report form see you on the gcp mindset channel and don't forget it's all about mindset gcp mindset take care hey there don't forget like and subscribe but most importantly click that bell so you never miss another video