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Content: Although the NIAID ClinRegs website contains information of a legal nature, it is intended for informational purposes only. It does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction, including the United States. The Federal Register and the Code of Federal Regulations remain the official sources for regulatory information published by the United States. While every effort is made to provide accurate and complete information, the laws, regulations, and guidelines referenced are often complex and may provide more details than are provided on this site. Also, since new standards are issued on a continuing basis, NIAID cannot guarantee that this site is free of inaccuracies and reflects the most current information available. Users should check with local authorities and/or research ethics committees before commencing research activities.

When a country’s regulatory requirements are not available in English, the content provided is developed using unofficial sources or automated translation services.

Occasionally this site houses country-specific regulatory documents when they are otherwise not available online. Though we strive to provide the most current information available, these documents cannot be guaranteed to be the most up-to-date versions. Also, they may not be Section 508 compliant, in which case users should contact the documents' authors to request accessible versions.

Links to External Websites and Documents: This site primarily contains links to non-U.S. Government websites and documents, which are provided for the convenience of the user. Such use does not constitute an official endorsement or approval by NIAID of any external website, document, product, or service. Users are subject to the external site's privacy policy when leaving this site. We are not responsible for Section 508 compliance on other federal or private websites or documents.

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Google Translate Disclaimer: ClinRegs content is published in English. ClinRegs offers translations of the content through Google Translate, which is an external translation service. ClinRegs does not control the quality or accuracy of translated content and may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages.

Use the symbols below to refine your search
SymbolExplanation
No symbol At least one of the keywords must be present
Search example: serious adverse event
Result: Will contain serious and/or adverse and/or event
+ Leading plus sign indicates that the word must be present
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Result: Will contain adverse and may contain serious and/or event
- Leading minus sign indicates that the word must not be present
Search example: serious adverse -event
Result: Will contain serious and/or adverse but won’t contain event
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Search example: “serious adverse event”
Result: Will contain the phrase serious adverse event
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ClinRegs content is published in English. ClinRegs offers translations of the content through Google Translate, which is an external translation service. ClinRegs does not control the quality or accuracy of translated content and may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages.