Clinical Investigator Brochure Template
Investigator s brochure guideline 10 july 2002 3 introduction the investigator s brochure ib is a compilation of all relevant nonclinical and clinical data for a drug undergoing clinical investigation.
Clinical investigator brochure template. It is an important source of information for clinical investigators institutional review boards irbs. Investigator brochure or imp dossier development sop. This ib focuses on research and information relevant to researchers and regulators engaged in clinical trials with mdma.
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. The investigator must provide the hrec with a current copy of the investigator s brochure at the time of ethics submission. Essential documents checklist investigator site file master file set up and maintenance sop.
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. Budget monitoring tool. The amended regulations si 2006 1928 state that the sponsor of a clinical trial is responsible for the investigator brochure ib and shall ensure that the trial ib presents the information it contains in a concise simple objective balanced and non promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk benefit.
Non clinical studies the study design and animal species or tests systems used should be stated. Budget monitoring tool with example data. Trial master file contents list.
5 9 agreement s 5 10 labelling. The dcsi is an integral part of the investigator s brochure and documents the adverse events which based on the information available so far could be reasonably assumed to be associated with enter compound number and therefore considered expected for the purposes of expedited reporting to regulatory authorities and investigators. Procedure 5 1 content of the investigator s brochure the sponsor investigator delegate is responsible for creating and maintaining the ib in accordance with this sop.
Ucl jro ib template v1 0 14th february 2019 confidential page 6 of 13 4. Systematic independent examination of activities and documents related to clinical investigation to determine whether these activities were conducted and the data recorded analysed and. 5 5 investigator s brochure ib 5 6 case report forms crfs 5 7 monitoring plan.
