By Richard Chin, Menghis Bairu
This e-book will discover the good possibilities and demanding situations which exist in carrying out scientific trials in constructing international locations. via exploring a number of the rules particular to the main avid gamers and delivering perception into the logistical demanding situations together with language boundaries, this ebook presents a operating instrument for medical researchers and directors to navigate the intricacies of scientific trials in constructing international locations. very important issues resembling moral matters should be dealt with very conscientiously to focus on the numerous alterations of undertaking this paintings in a number of jurisdictions. total, it's going to current a transparent and entire consultant to the ins-and-outs of medical trials in quite a few nations to aid in layout, improvement, and effectiveness of those trials.
- Contributors comprise high-profile, revered figures who've cleared the path for medical trials in constructing countries
- Provides hands-on instruments for regulatory and felony requisites and qualification, layout, administration, and reporting
- Case reports define successes, disasters, classes discovered and customers for destiny collaboration
- Includes country-specific guidance for the main applied countries
- Foreword via David Feigel, former Head of CDRH at FDA
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Extra resources for Global clinical trials : effective implementation and management
Of these, only half have IRBs, many without the expertise to evaluate protocols . • Of published clinical trials conducted in China in 2004, 90 percent proceeded without a prior ethical review of protocols. Eighteen percent satisfied the requirements for obtaining subjects’ informed consent . • In 1991, the US Department of Health and Human Services issued a set of guidelines (“Federal Policy for the Protection of Human Subjects”), referred to as the “Common Rule”, incorporating standards for IRB membership, function, operations, review, and record-keeping in trials funded or regulated by federal agencies and the FDA.
5. CONTROL AND INSPECTIONS OF FOREIGN SITES In general, most regulatory authorities do not extend jurisdiction over conduct of studies in other countries. That is, the Spanish regulatory agency will not care that patients are being dosed in a clinical trial in Japan. However, almost all regulatory authorities will require sponsors to keep them updated of new safety events that occur anywhere in the world. A few agencies, such as the FDA, will require investigators to follow US laws if they are conducting studies under US investigational new drug (IND) applications.
The sponsor must allow the authority to share data with the WHO. The NRA must have undergone an assessment by the WHO and been found to meet the requirements of the WHO. Once the marketing authorization from the NRA has been approved (except in special cases such as emergencies), the sponsor and the WHO should hold a pre-evaluation meeting. A product summary file is then submitted, with the following content : • Chapter 1: General information • Chapter 2: Personnel • Chapter 3: Premises and equipment • Chapter 4: Vaccine composition • Chapter 5: Production • Chapter 6: Quality control • Chapter 7: Stability • Chapter 8: Clinical experience • Chapter 9: Production and distribution data • Chapter 10: Update of Regulatory Authority actions relevant to the product.
Global clinical trials : effective implementation and management by Richard Chin, Menghis Bairu