Change in Research Submission Form

CHANGE IN RESEARCH SUBMISSION FORM ► HANDWRITTEN FORMS WILL NOT BE ACCEPTED ◄

Please indicate the source or type of submission. Sponsor or CRO: Protocol level Investigator-initiated study: Amendment Study Site / SMO amendment or modification and/or modification GENERAL STUDY INFORMATION

Sponsor: Protocol Number: Indicate the name(s) of the Principal Investigator for whom you are submitting this change. If you are submitting this on behalf of multiple investigators, provide a complete listing of their names or indicate “ALL.”

Protocol Amendment or Modification N/A Indicate the type(s) of change that you are submitting for review. Select all that apply: Subject Recruitment and Retention Materials Other Subject Materials (diaries, ID cards, etc.) What kind of subject material are you submitting? Revised versions of previously New recruitment materials New or revised screening procedures submitted materials Revised written or verbal New written or verbal New or revised public service screening materials screening materials announcements Planned protocol deviation(s) Administrative Letter to the Protocol

*Protocol (Version ) *Revised Investigator Brochure (or equivalent) *For protocols and revised Investigator Brochures, please submit a redlined version of the revised document or detailed summary description of each change and rationale for the changes, if not included in the revised version itself. **Addition of new consent form(s) **Change to existing consent form(s) – Consent Type: Please make sure that the requested changes are clearly documented on a copy of the most recently approved consent form (such as a REDLINED document). **With which subjects do you intend to use the revised /new consent? All Current and Future Subjects Future Subjects Only Other – please specify:

Other – please specify:

Please provide rationale for this change/modification and/or identify the page(s) within the submitted material where the rational for the change can be located.

Aspire IRB 11491 Woodside Avenue Santee, CA 92071 619.469.0108 (phone) 619.469.4108 (fax) Version Date: 29 June 2016 Page 1 of 4 CHANGE IN RESEARCH SUBMISSION FORM ► HANDWRITTEN FORMS WILL NOT BE ACCEPTED ◄

Site Specific Changes N/A Indicate the type(s) of change that you are submitting for review. Select all that apply: Site Phone Number Previous Phone Number: New Phone Number:

24-hour Site Contact Number Previous Phone Number: New Phone Number: Name of person associated with the new number:

Email Address Previous Email Address: New Email Address: Name of person associated with the new address:

Change of Site Contact Name of New Site Contact: Phone Number: Email Address: Contact Role: Study Coordinator Regulatory Contact Site Contact Does a previous contact need to be removed?: Yes No If yes, please list the name(s) that need to be removed as a study contact:

Change of Mailing Address Previous address Company Name: Address: City: State: Zip Code:

New address Company Name: Address: City: State: Zip Code:

*Additional or Relocated Site *If you have marked this box, please also complete and submit a Site Information Form. A site is being relocated A site is being added Location Name: Address: City: State: Zip Code:

Contact Person for this site: Phone Number: Email address: Contact Role: Study Coordinator Regulatory Contact Site Contact What is the approximate distance from this site to the main site? 49 miles (79 kilometers) or less 50 miles (80 kilometers) or more Would you like your Informed Consent(s) revised to include this new location? Yes No Will staff be added to the study team to cover the sites? Yes No

Change of Principal Investigator (PI) If you are submitting for a Change of PI, the new PI must be taking over the responsibilities at the same location as the current PI. Please also submit an Initial Study Application with the new PI’s information. Please also include a current, signed/dated (within the last two years) Curriculum Vitae (CV) and any relevant medical licenses. Currently Approved PI’s Name: Proposed New PI’s Name:

Translations N/A Indicate the type(s) of change that you are submitting for review. Select all that apply: Do you need any of these changed documents translated? Yes No List the documents that need translation: What language is needed: If you are enrolling non-English Speaking subjects, you must have plans for 1) conducting the consent discussion in the language understandable to the subject, and for 2) ongoing communications with the subject throughout the research and in case of emergency. Select all that apply. At least one member of the research team is fluent in the language that will be used for communication, and the research staff member(s) will be available during emergencies The research team has 24-hour access to a translation service with sufficient medical expertise to discuss the research in this study Other - specify:

PERSON COMPLETING THIS FORM Name: Company: Title: Phone No.: Email address:

Aspire IRB 11491 Woodside Avenue Santee, CA 92071 619.469.0108 (phone) 619.469.4108 (fax) Version Date: 29 June 2016 Page 4 of 4