NUMBER / DATE / PAGE
HRP-213 / 12/27/2012 / 1 of 2
Use to request a modification to previously approved research
IRB Number:
Protocol Name:
Investigator:
Primary Contact:
Does this modification include a change in research personnel? Yes; No
If yes,
· If any contact information has changed or any study personnel has been added and do not have a Contact Information form on file with IRB, the Contact Information form must be completed and included with this submission.
· The Application for Human Research must be updated and included with this submission showing changes in staff.
· If the addition/deletion of staff impacts the information provided on the protocol summary, an updated protocol summary must be provided
Study Status as a Result of this Modification (check all that apply)
Enrollment is suspended. Effective Date: If not previously reported, please provide explanation on separate sheet.
Enrollment is suspended. Request to re-open upon approval of this revision/addition.
Enrollment is open. Actively enrolling subjects.
Enrollment is permanently closed. Effective Date:
Are any subjects receiving active intervention? Yes; No; N/A
Are any subjects on long-term follow-up? Yes; No; N/A
Summarize the Modification or Attach a Summary:
Explain what the plan is for communicating these changes to the participant(s):
Provide copies of the following materials when they have been modified or are now applicable (new) with your modification form.
ApplicationApplication for Human Research Note: If any of the modifications impact the content of your application form, you must revise it to be reflective of these changes and submit a current version. Highlight/bold any changes made from the previous version
Appendix A: Internal Departmental Approvals
Appendix B: External Site Approvals
Appendix C: Children
Appendix D: Drugs/Biologics
Appendix E: Devices
Documents
Protocol
Investigator Protocol Summary (Note: If any of the modifications impact the content of this form, you must revise it to be reflective of these changes and submit a current version.) Highlight/bold any changes made from the previous version
Data Collection Instruments (if investigator initiated research)
Contact Information Form (for any research staff members who do not already have a form on file in the IRB Office and any existing staff members with updated information)
COI Screening Form (for any research staff member who do not already have a form on file with the IRB Office and any staff members with updated disclosure information)
All written material to be provided to or meant to be seen or heard by subjects, including:
Evaluation Instruments (to be completed by subjects) and Surveys
Advertisements (printed, audio, and video)
Recruitment Materials (letters, phone scripts, posters)
Consent Documents or Information Sheets (Note: include tracked changes and clean versions.)
Foreign language version of any written material to be provided to or meant to be seen or heard by subjects.
If consent will not be documented in writing, a script of information to be provided orally
Provide the following documents when they exist:
Investigator’s brochure for each investigational drug/biologic
Package insert for each marketed drug/biologic
Product information for each investigational device
Other:
Investigator Acknowledgement
I agree to conduct this Human Research in accordance with applicable regulations and the organization’s policies and procedures.
Investigator Signature / Date
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