Additional Site Location Form

Additional Site Location Form

Submit this form for each additional site. If the additional site is being added after initial approval, also complete the Change of Site Information Form.
SECTION 1.0: Study Information
1. PI/QI Name: / 2. Sponsor: / 3. Protocol No.:
SECTION 2.0: Additional SiteInformation
1.Location & Contact Information:
Site Name: / Address:
City: / State/Province: / Phone:
Postal Code: / Country: / Email:
2.Should theadditional site be listed on the IC?
No / Yes
3.Will theadditional site be utilizedsolely to perform specific, standard of care procedures related to the study?
No Continue to Section 3.0
Yes Complete a. through c.
a.Check here to confirm that the additional site named above will not be utilized to consent subjects, house or administer investigational product, or perform investigational procedures.
b.The following non-investigational study related procedures will be performed at the additional site:
c.An authorized official of the additional site (e.g. IRB Chairperson, Institutional Official, Director, Administrator, or CEO) must be aware that the facility will be used for study related procedures. Provide the name and title of the facility official that has been notified and the date of notification:
Name: / Title: / Date Notified:
If you answered a., b. and c. above, please submit the form now. You do not need to complete Section 3.0.
SECTION 3.0: Additional Site Information – With Research Activities
Complete this section only if research activities will be conducted at the additional site (response to 2.3 above is No).
1.Describe the additional site facility:
Dedicated Research Facility / Surgery Center Submit a Research Oversight Jurisdiction Form
Private Practice / Nursing Care Facility Submit a Research Oversight Jurisdiction Form
Free-standing Psychiatric Facility / Hospice Submit a Research Oversight Jurisdiction Form
Public Health Clinic / Other:
Hospital or Hospital System Owned or Affiliated Submit a Research Oversight Jurisdiction Form
If checked, provide the name of the hospital system or parent organization:
University/Academic Medical Center Owned or Affiliated Research Oversight Jurisdiction Form
If checked, provide the name of the university/academic medical center or parent organization:
2.In addition to access to 911, what resources are available at the additional site for subjects in need of emergency care? Check all that apply:
ACLS certified staff / CPR certified staff
Automatic external defibrillator / On-site paramedics
Crash cart with emergency medications / None
Other:
3. How far is the nearest hospital from the additional site?
Distance: / -OR- / Travel Time:
4.Is the additional site under the jurisdiction of or affiliated with another IRB/REB or human research protection program (HRPP)?
No / Yes Submit a Research Oversight Jurisdiction Form
Version: July 1, 2016 / © 2016 Copyright SCHULMAN / Page 1 of 1