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The Food and Drug Administration (FDA) publishes many helpful guidance documents, which represents the Agency's current interpretation on a particular subject. Links to the guidance documents from the following centers are listed below:
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The FDA also publishes Information Sheets that provide guidance and recommendations for IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects who participate in FDA-regulated research.
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The OHRP's website provides multiple guidance documents which represents their current thinking on a topic. These documents should be viewed as recommendations.
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The OHRP website also has a 'Frequently Asked Questions' section that serves as a good reference for IRBs, sponsors and investigators.
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OHRP: significant findings and concerns noted in compliance oversight determination letters over the last several years are outlined in the following document.
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FDA: examples of common non-compliance issues noted during routine FDA audits of investigators and sponsors are highlighted in these selected determination letters.
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- Failure to obtain informed consent
- Failure to ensure investigation is conducted according to the signed agreement, investigational plan and FDA regulations
- Failure to maintain accurate, complete and current subject records
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Example 1
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- Failure to obtain signed and dated informed consent documents
- Failure to maintain device accountability records
- Failure to conduct study in accordance with the investigational plan
- Failure to maintain accurate, complete, and current subject records
- Failure to submit progress reports to the sponsor and reviewing IRB
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Example 2
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- Failure to conduct the study according to signed investigator agreement, investigational plan, applicable FDA regulations and any conditions of approval imposed by FDA or the IRB
- Failure to maintain accurate and complete records for each subject's case history and their exposure to the device
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Example 3
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- Failure to ensure investigations were conducted according to the signed investigator statement
- Failure to maintain adequate and accurate case histories that record all observations and other pertinent data
- Failure to obtain informed consent in accordance with the provisions of 21CFR50
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Example 4
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- Failure to ensure that a compliant IRB was responsible for the continuing review and approval
- Failure to adequately document informed consent
- Failure to promplty report to the IRB all unanticipated problems involving risk to human subjects
- Failure to conduct the study according to the investigational plan
- Failure to maintain adequate records of the disposition of the investigational new drug
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Example 5
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