Skip to main content

What goes into the Investigator’s Brochure?

BayBiotech.NET
As per ICH guidelines, the overall aim of an Investigator’s Brochure is to provide the investigator with a clear understanding of the possible risks and adverse reactions, and of specific tests, observations and precautions that may be needed to conduct a clinical trial maintaining the safety of the patients enrolled for the study. This information must be based on scientific data produced by performed physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information of the investigational drug or device. Based on the scientific studies, the Investigator’s Brochure is intended to provide the Investigator with necessary management of study subjects throughout the clinical trial. Main focus must be given to the following measures:
A. Dose
B. Frequency of the dose
C. Method of administration
D. Safety monitoring procedures
E. List of abbreviations and acronyms
F. Description of the formulation of the drug
G. Instructions for the storage

Reference:
ICH Topic E 6 (R1) Guideline for Good Clinical Practice

Comments

Post a Comment

Popular posts from this blog

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...
Post a Comment
Read more

Available Total Quality Management Tools

BayBiotech.NET Total Quality Management (or TQM) is a management concept coined by W. Edwards Deming. One of the principal aims of TQM is to limit errors to 1 per 1 million units produced. There are several TQM tools available today to analyze and assess qualitative and quantitative data. These tools can be examined and used to enhance the overall quality of the procedures, products or the work environment. Some of the most common TQM tools in use today are Pie Charts and Bar Graphs, Histograms, Run charts, Pareto Charts, Force Field Analysis, Ishikawa or Fishbone Diagrams, Tree Diagrams, Brainstorming, Flow Charts, Plan-Do-Check-Act cycle and Scatter Diagrams. Proper integration and use of these tools ultimately assist in processing data such as identifying collecting policies, enhancing work flows, ensuring client satisfaction by surveying their needs and analyzing them accordingly and creating an overall high level of quality in all areas of your organization. Use and choice...
Post a Comment
Read more

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of...
1 comment
Read more