Investigator Brochure Template Medical Device

2 3 rationale for design.

Investigator brochure template medical device. E6 good clinical practice. Determinant of the investigational medical device safety or performance parameters and is usually used to calculate the sample size. B 2 investigational device information. Information supplied by the manufacturer of medical devices 5.

Example investigator s brochure for medical device investigations. 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. Summary of the medical device and include identification of any features of design that are. 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.

Clinical protocol s refer to clinical components. Consolidated guidance pdf 262kb. Different from a previously similar marketed product if relevant. Sample investigator s brochure template free download and preview download free printable template samples in pdf.

Clinical investigations of medical devices guidance for investigators november 2013 5 10 5 humanitarian use of non ce marked devices the use of an individual non ce marked device falling within the scope of the active implantable medical devices directive or the medical devices directive may be authorised by the mhra on. 2 5 explanation of how device functions. Annex b investigator s brochure ib b 1 general. To describe the procedures related to investigator s brochure content design amendments filing and distribution for mcri developed products used in clinical trials of investigational medicinal products imps and investigational medical devices imds sponsored by mcri.

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. The investigator s brochure ib is a multidisciplinary document that summarises the main elements of an entire development programme to date. 2 6 intended performance of device.