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MAYO CLINIC CANCER CENTER Eligibility Checklist 2/5/2015-Page 1 of 4 MC1382: Phase 1/2 trial of MLN9708 in combination with and in patients with previously untreated symptomatic multiple myeloma Phase
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Start by identifying the phase i patients within your dataset or patient records. This can be done by reviewing their medical history or any relevant criteria that determines their inclusion in phase i.
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Ensure that you have all the necessary forms or documents required for collecting data on phase i patients. This may include consent forms, questionnaires, or specific data collection sheets.
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Who needs phase i patients only:

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Researchers conducting phase i clinical trials require phase i patients only. These trials are usually the first step in a drug development process, aiming to assess the safety and dosage of a new medication in a small group of human participants.
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Pharmaceutical companies or biotech firms involved in drug development rely on phase i patients to collect crucial data and evaluate the initial effectiveness and safety of their investigational products.
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Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), also require data from phase i patients to assess the potential risks and benefits associated with new drugs before granting approval for further clinical trials or market release.
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Phase I patients only refers to a group of patients who are in the initial stage of a clinical trial to test the safety and dosage levels of a new medication or treatment.
Healthcare professionals conducting the clinical trial are required to file phase I patients only reports.
Phase I patients only reports can be filled out electronically using the designated form provided by the regulatory body overseeing the clinical trial.
The purpose of phase I patients only reports is to monitor and track the progress, safety, and efficacy of new medications or treatments being tested in clinical trials.
Phase I patients only reports typically include patient demographics, medical history, treatment regimen, adverse reactions, and other relevant data.
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