|Age:||2 years or older|
|Keywords:||Inflammatory Bowel Disease, IBD, Crohn’s disease, CD, ulcerative colitis, UC, Indeterminate Colitis, IBDU, gastrointestinal, GI|
If you agree to take part in this study and qualify to enroll in the study, there will be a Screening/Enrollment Visit and a Follow-Up Period.
Screening/Enrollment Visit (Visit 1) You will enrolld at a regularly-scheduled clinic visit. The following will occur at the visit:
Consent to main observational study
Review study criteria to determine if you are eligible for the study
Complete demographic data form including: o Year of birth o Gender o Race o Ethnicity (Hispanic or non-Hispanic) o Weight o Height o Smoking status o Insurance type
Following the Screening/Enrollment visit, up to three years of your historical medical records may be collected, redacted, and sent to the study sponsor, TARGET PharmaSolutions, Inc.
You may also choose to take part in optional sub-studies beyond the main observational study:
Optional Sub-Study #1: Blood sample collection
Optional Sub-Study #2: Questionnaires
Optional Sub-Study #3: Link of your health information to an external healthcare database
If you consent to Sub-Study #1, a blood sample (approximately 1 tablespoon) will be collected from you. When possible, this sample will be collected during regular clinical bloodwork. If it is not possible to do so, blood will be collected by a separate needlestick.
If you consent to Sub-Study #2, you will complete patient reported outcome (PRO) questionnaires at your initial visit and at up to 3-month intervals on paper.
If you consent to Sub-Study #3, your health information will be linked to an external healthcare database. The details of the optional sub-studies and their respective consent forms are further outlined at the end of this document.
Follow-Up Period (Months 6-60) The Follow-Up period will start at Month 6 (6 months following your initial visit) and will continue for up to 5 years (Month 60). Your medical records will be collected throughout this follow up period, redacted, and sent to the study sponsor. If you consented to the optional patient questionnaires, you will be asked to complete these assessments at up to 3-month intervals. If you consented to the optional blood sample, you will be asked to provide an annual blood sample (approximately 1⁄2 tablespoon). No other study procedures are required during this time. At Month 60, your participation in the study will be complete and no additional medical records will be collected.