Screenshot TBD.

How to Complete the Trial Details Section

  1. In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    Field Label

    Description/Instructions

    Title*

    Enter the official name of the protocol provided by the study principal investigator or sponsor. (Limit 4000 characters)
    For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"

    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.

    Select N/A for observational and ancillary-correlative trials.

    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.

    Trial Type*

    Select the trial type indicated in the protocol. 

  2. If you selected interventional as the trial type, select or enter the appropriate information in the following fields. The following table describes the fields. An asterisk (*) indicates a required field.

    Field Label

    Description/Instructions

    Primary Purpose*

    1. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions.

    2. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose 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.

    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 purpose in the text field provided.
    Accrual Disease Terminology*

    Click to select the disease terminology used to report subject accruals for this trial.

  3. If you selected non-interventional as the trial type, select or enter the appropriate information in the following fields. The following table describes the fields. An asterisk (*) indicates a required field.

    Field Label

    Description/Instructions

    Non-Interventional Trial Type*

    Select one of the following trial types:

    Primary Purpose*

    1. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions.

    2. If none of the values is appropriate, select Other, and then enter the same Non-Interventional Study Type you selected earlier, either Observational or Ancillary -Correlative , in the text field.

    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.

    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.

    Site Principal Investigator*

    Click Look Up Person and search for the principal investigator. For instructions, refer to Looking Up Registered Persons.