Recording Interventional Trial Details - Include 20170907

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.

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.

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.

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

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

Secondary Purpose

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.

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).

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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