Investigator Brochure Template Medical Device
The purpose of the investigator s brochure ib is to provide the principal investigator s with sufficient safety or performance data from pre clinical investigation s and or clinical investigation s to justify human exposure to the investigational device specified in the clinical investigational protocol.
Investigator brochure template medical device. The ib must be. This 21 page investigator s brochure template is intended to assist you in the process of drafting an investigator s brochure for devices based on ich topic e 6 r1 guideline for good clinical practice. Investigator s brochure for medical device investigations.
Relate to other indications for use of the investigational device. Determinant of the investigational medical device safety or performance parameters and is usually used to calculate the sample size. Canva s medical brochure templates help you solve that dilemma.
Summary of the medical device and include identification of any features of design that are. Sample investigator s brochure template free download and preview download free printable template samples in pdf. Investigational medical device medical device being assessed for safety or performance in a clinical investigation.
Any hospital staff can learn how to create stunning brochures in minutes so you don t have to hire a graphic designer. The investigator s brochure ib is a multidisciplinary document that summarises the main elements of an entire development programme to date. And with medical devices that have similar characteristics including such characteristics that.
Although the ib also serves other purposes it is primarily written to enable investigators conducting clinical studies to assess the risks and benefits associated with an investigational product. Summary of data and guidance for the investigators. Secondary hypotheses concerning other points of.
The investigator s brochure ib will be produced following the ich guidelines. Different from a previously similar marketed product if relevant. Information supplied by the manufacturer of medical devices 5.
Annex b investigator s brochure ib b 1 general. Download layouts for adobe indesign illustrator microsoft word publisher apple pages. Our online graphic design tool was especially created with ease of use in mind.
Medical health care brochure templates create eye catching medical and health care brochures quickly and easily with our customizable graphic designs. It is however possible to add sub headings within a section as appropriate.
