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 |
---|---|
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. For valid values, refer to Primary Purpose Value Definitions. 2. If the primary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided. The text field is displayed only after you have selected Other. |
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. For valid values, refer to Trial Phase Value Definitions. |
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. |