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.
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.
When you specify trial data in CTRP, the system requires you to specify the phase of investigation, as defined by the US FDA for trials involving investigational new drugs. The following table provides a definition of each phase and maps the ClinicalTrials.gov values to the CTRP values:CTRP Phase Value ClinicalTrials.gov Phase Value Definition Early Phase I Early Phase 1 (Formerly listed as "Phase 0") Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). See FDA guidance on exploratory IND studies for more information. I Phase 1 Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. I/II Phase 1/Phase 2 Trials that are a combination of phases 1 and 2. II Phase 2 Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks. II/III Phase 2/Phase 3 Trials that are a combination of phases 2 and 3. III Phase 3 Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. IV Phase 4 Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. NA N/A Trials without phases (for example, studies of devices or behavioral interventions). 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.
CTRP allows you to choose one of the following values when specifying the main reason for conducting the trial.CTRP Primary Purpose Value Definition Treatment Protocol is designed to evaluate one or more interventions for treating a disease, syndrome, or condition. Prevention Protocol is designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition. Supportive Care Protocol is designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease. Screening Protocol is designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). Diagnostic Protocol is designed to evaluate one or more interventions aimed at identifying a disease or health condition. Health Services Research Protocol is designed to evaluate the delivery, processes, management, organization, or financing of health care. Basic Science Protocol is designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. Device Feasibility An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
Other Any purpose not described above. - Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose 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.
Secondary Purpose 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.
- If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
Accrual Disease Terminology*
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:
- Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. The participants in the study may receive diagnostic, therapeutic, or other interventions but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study.
- 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.
Primary Purpose*
Select the primary reason for conducting the trial. The following list provides valid values.
CTRP allows you to choose one of the following values when specifying the main reason for conducting the trial.CTRP Primary Purpose Value Definition Treatment Protocol is designed to evaluate one or more interventions for treating a disease, syndrome, or condition. Prevention Protocol is designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition. Supportive Care Protocol is designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease. Screening Protocol is designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). Diagnostic Protocol is designed to evaluate one or more interventions aimed at identifying a disease or health condition. Health Services Research Protocol is designed to evaluate the delivery, processes, management, organization, or financing of health care. Basic Science Protocol is designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. Device Feasibility An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
Other Any purpose not described above. - 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.
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.
- 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
- 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*
Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values.
- Prospective - Look forward using periodic observations collected predominantly following subject enrollment
- Retrospective - Look back using observations collected predominantly prior to subject selection and enrollment
- Cross-sectional - Observations or measurements made at a single point in time, usually at subject enrollment
- Other - Any time perspective not described above
- 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.
Site Principal Investigator*
Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons .
