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. For valid values, refer to Primary Purpose Value Definitions - Include 20170406.

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.

Field LabelDescription/Instructions

Title*

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

Trial Type*

Select Non-Interventional.

Non-Interventional Trial Type*

Select one of the following trial types:

  1. Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants.
  2. Include Page
    ancillary-correlative Definition - Include v4.4
    ancillary-correlative Definition - Include v4.4

Primary Purpose*

1. Select the primary reason for conducting the trial from the following values.

Include Page
Primary Purpose Value Definitions - Include 20170406
Info

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.

Include Page
Non-Interventional Study Model - Include v4.4
Non-Interventional Study Model - Include v4.4

2. If the study model is Other, type a detailed description of the trial’s study model in the text field provided.

Info

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.

Include Page
Non-Interventional Time Perspective - Include v4.4
Non-Interventional Time Perspective - Include v4.4

2. If the time perspective is Other, type a detailed description of the trial’s time perspective in the text field provided.

Info

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 For valid values, refer to Trial Phase Value Definitions.

Info

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

Include PageTrial Phase Values - Include 20170406Trial Phase Values - Include 20170406

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.