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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. (Limit 4000 characters) | ||||||||
Trial Type* | Select Interventional (the default). | ||||||||
Primary Purpose* | 1. Select the primary reason for conducting the trial. The following list provides valid values.
2. If the primary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
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Secondary Purpose | 1. Select one of the following reasons for conducting the trial.
2. If the secondary purpose is Other, enter a detailed description of the trial’s secondary purpose in the text field provided. | ||||||||
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 follow the instructions in Looking Up Registered Persons to select the site principal investigator. |