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Select or enter In the various fields, specify the appropriate information in the following fields. 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. The following list provides valid values.
Include Page Trial Phase Values - Include 20170406 Trial Phase Values - Include 20170406 Info 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.
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*
Select the primary reason for conducting the trial. The following list provides valid values.
Include Page Primary Purpose Values Value Definitions - Include 20170406 Primary Purpose Values Value Definitions - Include 20170406 - Optionally, if the primary purpose is Other, type 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. The limit is 200 characters; the system counts down the character numbers as you type.
Secondary Purpose Select one of the following reasons for conducting the trial.
Include Page Secondary Purpose Values - Include v4.4 Secondary Purpose Values - Include v4.4 - If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
Accrual Disease Terminology*Anchor 7316 7316 Click to select the disease terminology used to report subject accruals for this trial.
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:
Include Page Observational Study Definition - Include v4.4 Observational Study Definition - Include v4.4 Include Page Ancillary-Correlative Definition - Include v4.4 Ancillary-Correlative Definition - Include v4.4
Primary Purpose*
Select the primary reason for conducting the trial. The following list provides valid values.
Include Page Primary Purpose Values Value Definitions - Include 20170406 Primary Purpose Values Value Definitions - Include 20170406 - If none of the values is appropriate, select Other, and then enter the same Non-Interventional Study Type you selected earlier, either
ObservationalorAncillary -Correlative, in the text field.
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.
Study Model Code*
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 - 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*
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 - 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.
Site Principal Investigator*
Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons .
