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Field Label | Description/Instructions | ||||||||
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Title* | Enter the official name of the protocol provided by the study principal investigator or sponsor. | ||||||||
Trial Type* | Select Non-Interventional. | ||||||||
Non-Interventional Trial Type* | Select one of the following trial types:
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Primary Purpose* | 1. Select the primary reason for conducting the trial from the following values.
2. If your trial does not fall into one of these categories, select Other, and note the type of trial in the corresponding text box.
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Study Model Code* | 1. Select the primary strategy for subject identification and follow-up. The following list provides valid values.
2. If the study model is Other, type a detailed description of the trial’s study model in the text field provided.
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Time Perspective Code* | 1. Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values.
2. If the time perspective is Other, type a detailed description of the trial’s time perspective in the text field provided.
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Phase* | Select the phase or stage of the clinical trial as defined by the US FDA, from the drop-down list. The following list provides valid values.
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Is this a Pilot? | Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pilot trial. | ||||||||
Site Principal Investigator* | Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons. |