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Screenshot TBD.

How to Complete the Trial Details Section

Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. All fields other than Secondary Purpose are requiredAn 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)
For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"

Trial Type*

Select Interventional (the default).

Primary Purpose*

1. Select the primary reason for conducting the trial. The following list provides valid values.

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	Primary Purpose Values - Include 20170406
	Primary Purpose Values - Include 20170406

2. If the primary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.

Info
The text field is displayed only after you have selected Other.

Secondary Purpose

1. Select one of the following reasons for conducting the trial.

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	Secondary Purpose Values - Include v4.4
	Secondary Purpose Values - Include v4.4

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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	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 follow the instructions in Looking Up Registered Persons to select the site principal investigator.

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	registerdetailsnoninterventional

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Screenshot TBD.

How to Complete the Trial Details Section

Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. All fields are requiredAn 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.
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:

Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants.
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.

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	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.

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	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.

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	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 .

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	Trial Status Mapping - Include 20170331
	Trial Status Mapping - Include 20170331

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Screenshot TBD.

How to Complete the Status/Dates Section

Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. Items with an asterisk are required fieldsAn asterisk (*) indicates a required field.

Instructions for recording Site Recruitment Statuses/Dates

Field Label	Description/Instructions
Site Recruitment Status*	Select the current stage or state of the trial or study.
Site Recruitment Status Date*	Enter the date on which the current trial status became effective. See Trial Status Rules.
Date Opened for Accrual	If appropriate, enter the date on which the trial was opened for accrual.
Date Closed for Accrual	If appropriate, enter the date on which the trial was closed for accrual.

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