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Home
› Add Study
Add Study
Study Title:
*
Protocol title intended for the lay public, along with any sponsor assigned protocol number.
IRB 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.
Study Summary:
*
Enter brief summary of the study
Detailed Study Description (optional):
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.
Category:
*
-- select one --
Anesthesiology
Arthritis
Cancer, Breast
Cancer, General
Cancer, Prostate
Cardiology
Diabetes, Type 1
Gastroenterology
Healthy Controls
HIV/AIDS
Neurology
Nursing
Other
Radiology
Scleroderma
Study Design:
*
Blinded
Interventional
Observational
Retrospective
Phase of Study:
*
Phase 0
Phase I
Phase I / II
Phase II
Phase II / III
Phase III
Phase IV
n/a
Study Type:
*
-- select one --
Expanded Access
Interventional
Observational
Condition or Study Focus:
*
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.
Intervention Type:
*
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.
Intervention Name:
*
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.
Description of Study:
*
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).
Currently accepting patient participants:
*
-- select one --
Recruiting
Active, not recruiting
Completed
Who can participate:
*
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.
What do I have to do as a participant (optional):
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.
Gender Recruitment:
*
-- select one --
Male
Female
Male and Female
Age Recruitment:
*
Child (birth – 17)
Adult (18-65)
Senior (66+)
Sponsor(s):
*
Specify institutes, organizations, or companies that are conducting or otherwise supporting a trial.
Principal Investigator
First name:
*
Last name:
*
Email:
*
Phone:
*
Phone Ext:
Study Coordinator
First name:
*
Last name:
*
Email:
*
Phone:
*
Phone Ext:
Administrative data
(Will not be made public - for administrative purposes only.)
Involves IND/IDE?:
Yes
No
Indicate if the protocol involves an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) under US Food and Drug Administration regulations.
If yes, IND/IDE Grantor:
-- select one --
CDER - Center for Drug Evaluation and Research
CBER - Center for Biologics Evaluation and Research
CDRH - Center for Devices and Radiological Health
If yes, IND/IDE number:
Number assigned to an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE).
Display on ClinicalTrials.gov site?