Investigator Brochure Template Pdf
In the absence of detailed guidance or a template for the content of the investigator s brochure ib for advanced therapeutic medicinal product atmp development quality this document has been created as an authoring guide.
Investigator brochure template pdf. 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. Download and create your own document with the investigator s brochure 32kb 48 page s for free. 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 s brochure for atmp introduction. Blank investigator s brochure template free download and preview download free printable template samples in pdf word and excel formats. 3 investigator brochure template free download.
Free download investigator brochure pdf 527kb and customize with our editable templates waivers and forms for your needs. Maps investigator s brochure mdma page 5 symptom profiles and to reports from anecdotal research maps is conducting a protocol investigating changes in social anxiety experienced by autistic adults when using two sessions of mdma assisted therapy interspersed with biweekly non drug integration sessions. Non clinical studies the study design and animal species or tests systems used should be stated.
Ucl jro ib template v1 0 14th february 2019 confidential page 6 of 13 4.
