How to Complete the Trial Details Section
In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Instructions for recording Trial Details
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. Unable to render {include} The included page could not be found. 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. The text box is displayed only after you have selected Other. | |||||||||||||||||||||||||||
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. The text field is displayed only after you have selected Other. | |||||||||||||||||||||||||||
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. The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts down the character numbers as you type. | |||||||||||||||||||||||||||
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. Select N/A for observational and ancillary-correlative trials. When you specify trial data in CTRP, the system requires you to specify the phase of investigation, as defined by the US FDA for trials involving investigational new drugs. The following table provides a definition of each phase and maps the ClinicalTrials.gov values to the CTRP 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. |