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.
Select one of the following trial types:
- Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants.
Primary Purpose*
1. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions.
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.
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.
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. |
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.
Site Principal Investigator*
Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons.