A S S O C I A T E S I R B
Change ofSite Information Form
1.Submission information: Use this form to submit changes in primary or additional site information that occur after initial approval.2.Submission instructions: Submit viaSecure eSubmission oremail to .
SECTION 1.0: Study & Contact Information
1.Date: / 2.IRB No.:
3. Sponsor: / 4.Protocol No.:
5. PI/QI Name:
6.Contact information for this submission:
Name: / Company:
Phone: / Email:
SECTION 2.0: Change of Site& Investigator Information
Change of Primary Site InformationComplete questions 1. through 3.:
1. Has the primary site changed names?
No / Yes Provide the newprimary site name:
2. Has the phone number that appears on the Informed Consent (IC) changed?
No / Yes Complete a.andb.:
a. How would you like the office phone number (optional) to appear on the IC?
b. How would you like the 24-hour phone number (required) to appear on the IC?
3. Has the primary site location changed?
No / Yes Complete a.throughe.:
a. Provide the new primary site location information:
Site Name: / Address:
City: / State/Province: / Phone:
Postal Code: / Country: / Email:
b. Describe the new primary 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 Submit a Research Oversight Jurisdiction Form
If checked, provide the name of the university/academic medical center or parent organization:
c. Is the new primary site under the jurisdiction of or affiliated with another IRB/REB or human research protection program (HRPP)?
No / YesSubmit a Research Oversight Jurisdiction Form if not previously completed.
d.In addition to access to 911, what resources are available at the new primary 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:
e.How far is the nearest hospital from the new primary site?
Distance: / -OR- / Travel Time:
Change of Additional Site InformationComplete questions 4. through 6.:
4. Has an additional site changed names?
No / Yes Provide the old: and new: additional site name.
5.Are additional site locations for the study being removed?
No / Yes Provide the names of the additional locations being removed:
6.Are new additional site locations for the study being added?
No / Yes Submit an Additional Site Location Form for each new additional site location.
Change of Site Contact InformationComplete question 7.:
7.Is there a change of sitecontact associated with the change of site information?
No / Yes Complete the Contact Change Form
Note: Site contacts receive access to Schulman SiteAccess in order to download IRB documents and review status information.
Change of Investigator Complete question 8.:
8. Is there a change of investigator (PI and/or Sub-I) associated with the change of site information?
No / Yes Submit the Change of Investigator Form
SECTION 3.0: Study Status IC Information
1. What is the status of study enrollment?
Enrollment open / Enrollment closed / Site not yet initiated
2. What is the status of study subjects? Check all that apply:
Subjects active / No subjects active / Subjects in follow-up only (not receiving active intervention [e.g. IP, device])
Other:
Note: A revised IC will not be generated for sites that have closed to enrollment and have no active subjects unless specifically requested by the Sponsor/CRO. If enrollment reopens at your site contact Schulman.
3.Does the change of site information result in the need for change(s) to the current Schulman approved IC(s)?
No / Yes Complete a.throughc.:
a.Indicate one of the following:
Request Schulman apply the appropriate changes to the current Schulman approved IC(s).
Requested changes attached via tracked changes to the MS Word version of the current Schulman approved IC(s).
b.The revised IC is intended to be presented to: Check all that apply.
New enrollees / Only subjects receiving active intervention (e.g. IP, device)
All current subjects / Other:
Provide rationale if requesting not to reconsent all actively enrolled subjects:
Note: The final determination will be made by Schulman upon review of the change(s).
c. Specify one of the following regarding IC translation:
No IC translation is needed.
I will obtain my own translation through a certified translator and provide for Schulman review prior to use.
I authorize Schulman to translate the IC and the associated cost for: All previously translated languages
Only specified languages:
Note: Confirm authorization for translations with the sponsor/CRO prior to submission, if necessary.
Version: April 17, 2015 / © 2015 Copyright SCHULMAN / Page 1 of 2