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This way, the person will understand what they are agreeing to. The witness will also sign and date the form. An institution is a private or public entity, agency, medical facility, or dental facility where clinical trials have been conducted. 3. A Contract Research Organization (CRO) is an individual or a business that is hired by a sponsor to do some of the work related to a clinical trial. The product being investigated should be packed to avoid contamination and deterioration during storage and transport. An Unexpected Adverse Drug Reaction is a problem that happens during the study that is not normal. E6 has been amended to promote the implementation of advanced and more effective methods to clinical trial design, conduct, supervision, documenting, and reporting. 5.1 Quality Assurance and Quality Control. They also need to make sure that any unused product is disposed of properly according to all applicable laws and regulations. The investigator shouldn't do anything different from what is in the protocol without agreement from the sponsor. The person or their representative should be told about the trial as soon as possible and agree to continue with additional approval if needed. The sponsor must determine, for the investigational product(s), decent storage temperatures, storage requirements (e.g. A protocol amendment is a description of a change or clarification to a protocol. The investigator should also be familiar with the product that is being investigated and how to use it according to the protocol. Any changes must also have the amendment number(s) and date(s). 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