Add Study

Protocol title intended for the lay public, along with any sponsor assigned protocol number.
This is the IRB number assigned by the Clinical Research Program. Multiple studies conducted under the same grant or fund number must have a unique IRB number.
Enter brief summary of the study
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
Refer to the primary disease, disorder, syndrome, illness, condition, or injury being studied. May also include any health issue worth studying, such as lifespan, quality of life, health risks, etc. Diseases or conditions should use the National Library of Medicine's Medical Subject Headings (MeSH) controlled vocabulary when possible.
Interventions refer to the drug, biological, vaccine, procedure, device, Radiation, Behavioral, Genetic, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
For drugs use generic name; for other types of interventions provide a brief descriptive name. For investigational new drugs that do not yet have a generic name, a chemical name, company code or serial number may be used on a temporary basis. As soon as the generic name has been established, update the associated protocol records accordingly.
Displayed on web site. Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators).
Enter a summary description for participant selection. The preferred format includes listing inclusion and exclusion criteria. Please try to limit the text to 300 words and state simply.
Enter a description of the study-specific requirements that may impact retention and continued participation. Please try to limit text to 300 words and state simply.
Specify institutes, organizations, or companies that are conducting or otherwise supporting a trial.
Principal Investigator
Study Coordinator
Administrative data (Will not be made public - for administrative purposes only.)
Indicate if the protocol involves an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) under US Food and Drug Administration regulations.
Number assigned to an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE).