1. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions.

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

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

• Ancillary-Correlative. A trial that is secondary to another trial, or a type of trial that tests for a relationship between a condition and a potential causal factor of the condition.

  • Ancillary. Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Report only those studies that can be linked to individual patient or participant data.
  • Correlative. Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Report only those studies that can be linked to individual patient or participant data.
    
• Other.  Any purpose other than Ancillary-Correlative.

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

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.

Is this a Pilot?

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. Ancillary-Correlative. A trial that is secondary to another trial, or a type of trial that tests for a relationship between a condition and a potential causal factor of the condition.

   • Ancillary. Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Report only those studies that can be linked to individual patient or participant data.
   • Correlative. Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Report only those studies that can be linked to individual patient or participant data.
     

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.

1. Select the primary strategy for subject identification and follow-up. The following list provides valid values.

• Cohort. Group of individuals, initially defined and composed, with common characteristics (e.g., condition, birth year), who are examined or traced over a given time period
• Case-control. Group of individuals with specific characteristics (e.g., conditions or exposures) compared to group(s) with different characteristics, but otherwise similar
• Case-only. Single group of individuals with specific characteristics
• Case-crossover. Characteristics of case immediately prior to disease onset (sometimes called the hazard period) compared to characteristics of same case at a prior time (i.e., control period)
• Ecologic or community studies. Geographically defined populations, such as countries or regions within a country, compared on a variety of environmental (e.g., air pollution intensity, hours of sunlight) and/or global measures not reducible to individual level characteristics (e.g., health care system, laws or policies median income, average fat intake, disease rate)
• Family-based. Studies conducted among family members, such as genetic studies within families or twin studies and studies of family environment
• Other. Any model not described above

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

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.

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.

Is this a Pilot?