The Investigators Brochure

As a first step, the sponsor is required to prepare an investigator s brochure (IB). This must be an objective compilation of available clinical and non-clinical data on the 

Physical, Chemical, and Pharmaceutical Properties and Formulation Non-clinical Studies Non-clinical Pharmacology 

Pharmacokinetics and Product Metabolism in Humans Safety and Efficacy Marketing Experience 

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The ultimate expression of a toxicologist s preclinical labours which serves to address these moles are the safety sections of the investigations brochure (IB) and section 8 of the IND. Here are the last chances to guide a potential drug into safe development in humans. 

Supply of the investigator brochure, updates, product and documentation by the sponsor. (CRO may produce study documents such as... 

Review the investigator brochure (IB), safety information, information about payments and compensation to subjects, the investigator s current curriculum vitae, and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may require to fulfill its responsibilities. 

Be thoroughly familiar with the properties of the clinical study medications/devices as described in the investigator brochure... 

Reporting adverse experiences to the sponsor within the specified time Reading and understanding the Investigator Brochure Ensuring that the study staff is informed of their obligations in meeting these requirements... 

The investigator s brochure, the case report forms, the confirmation of insurance of subjects and the documents used to obtain informed consent... 

The Investigator s Brochure is a collection of information prepared and updated by the Sponsor for the Investigator. The information consists of all the data relevant to the drug under investigation, including properties of the drug, the PK and PD, and toxicity results on animals (Exhibit 6.8). 

Clinical Practice Section 7.3 Content of the Investigator s Brochure. London EMEA, 1996. 

The investigator s brochure provides more detail than the protocol in relation to the background of the study, and should help to facilitate a better understanding of the rationale for the protocol and its key features. In an ideal world, the potential investigator will receive the investigator s brochure before deciding to participate in the study. The brochure should provide the investigator with sufficient information to decide if the... 

The IRB is responsible for judging all studies to be conducted at the centre concerned by reviewing protocols, the informed consent sheet, the investigator s brochure and other materials relating to the conduct of clinical trials. The IRB is also responsible for monitoring whether the clinical trials are conducted in compliance with both GCP and IRB s requirements, if any. When the study period of a clinical trial exceeds 1 year the IRB should review the study every year. As the new GCP allows the study sponsor to pay a reasonable amount of money to the study subjects, the IRB is expected to review whether the amount and method of payment is reasonable and does not infringe upon the ethical aspects of the study. Also, the advertisement of a trial for patient recruitment is allowed, but the IRB s approval to implement this at the study centre is required. 

Under the CTN scheme the sponsor of the clinical trial provides detailed information about the proposed trial to the principal investigator who submits an application to conduct the clinical trial to the HREC at the institution or other site at which the trial is proposed to be conducted. The clinical trial application generally includes the protocol, the investigator s brochure, related patient information, supporting data and the CTN form. HRECs usually have their own standard format for applications to conduct a CTN trial at their institution. The HREC evaluates the scientific and ethical validity of the proposed clinical trial and the safety and efficacy of the medicine in the context of its stage of development. The TGA does not evaluate any information about the clinical trial. 

The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator s brochure identifies as not requiring immediate reporting. The immediate report shall be followed by detailed, written reports. The immediate and follow-up reports shall identify subjects by unique code numbers assigned to the latter. 

For CTAs, the Investigator s Brochure (IB) is an important document, as it generally represents all the nonclinical data submitted. Study reports are not routinely included unless the assessor considers... 

It is noteworthy that his letter to attorney Herrmann deliberately describes his relation to Remer incompletely by leaving out both of these events [revisionist gathering in Roding and arranging publication of the brochure Die Zeit liigt ,567]. The chamber is convinced from this that it does not reflect the true relations and the actual opinion of the accused on Remer, but was written expressly for the purpose of misleading the investigation process. ... 

In the event that there are additional documents included in the application, such as the investigator s brochure, provide the document behind a tab, in this case, labeled Investigator s Brochure. ... 

The successful IND is most likely a result of cooperative work with an integrated team represented by Regulatory, Quality Assurance, Clinical, CMC, and others. Quality Assurance, for example, is likely to have valuable input into the design of the Investigator s Brochure Clinical can contribute important direction and focus to the literature review Regulatory may have CMC input of value and so forth. The integrated team is more likely to both produce a smoothly integrated document and assure that the content of that document represents a cohesive and systematic assurance of public safety, which is the primary FDA focus. 

Investigator s Brochure. The Investigator s Brochure and accompanying study description will be carefully reviewed to make certain that the design is appropriate, meets standard criteria for blinding and control, and protects the human subjects (in initial screening, disclosure, administration, and followup). Safety of humans is the key element in the review the Investigator s Brochure should clearly and comprehensively address all relevant safety issues. 

Annual Report Except for the Investigator s Brochure [21 CFR 312.33(d)], you should provide the required information for an annual report as a single PDF hie. You will hnd the items required for the annual report listed in 21 CFR 312.33. As part of the annual report hie, you should provide a TOC listing each item detailed in 21 CFR 312.33. You should bookmark and hyperlink each item in the TOC to its referenced information in the document. Information on providing the Investigator s Brochure is provided below. 

Investigator s Brochure You should provide the Investigator s Brochure as a single PDF file. You should include a TOC in the Investigator s Brochure. You should name the file XXXX investbrochuretoc.pdf. You should bookmark and hypertext link the TOC for this file. 

D Investigator s Brochure Conformity with ICH Good Clinical Practice Guideline for the Investigator s Brochure... 

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