Indicates whether a clinical study allows people who do not have the condition or related conditions or symptoms being studied to participate in that study. (See also Accepts Healthy Volunteers data e [..]

A group of participants that receives an intervention that is considered to be effective. One of several Arm Types.

The clinical study is ongoing (that is, participants are receiving an intervention or being examined), but potential participants are not currently being recruited or enrolled. A type of Recruitment S [..]

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This chang [..]

A clinical trial design strategy used to assign participants to an arm of a study. Types of Allocations include randomized and nonrandomized. (See also Allocation data element on ClinicalTrials.gov.)

A group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.

A general description of the clinical study arm. It identifies the role of the intervention that participants will receive. Types of arms include Experimental, Active Comparator, Placebo Comparator, S [..]

Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and gender, and study-specific measures (for [..]

See Masking (or Blinding).

As required by Section 801 of the Food and Drug Administration Amendments Act, in general, a description of any agreement between the Sponsor of a clinical study and the Principal Investigator (PI) th [..]