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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 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 Values - Include 20170406
Primary Purpose Values - 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.

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 valid values.

Info

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

Include Page
Trial Phase Values - Include 20170406
Trial 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.