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 amendment or modification / Study Site / SMO / Investigator-initiated study: Amendment 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 submitted materials / New recruitment materials / New or revised screening procedures
Revised written or verbal screening materials / New written or verbal screening materials / New or revised public service 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)
Consent Type: / **Change to existing consent form(s) –
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 rationale for the change can be located.
Will this amendment/revised ICF require an update to the compensation section of the Informed consent document?
Yes- if marked “yes”, please see directions below. / No – if marked “No”, please go to the next section
If your sites will require that the compensation section in their individual ICFs need to be updated, it is the sites responsibility to supply the IRB with their desired language prior to the TEMPLATE being signed-off by the Sponsor/CRO. It is also the Sponsor/CRO’s responsibility to notify the sites that updated compensation needs to be supplied to the IRB within this time frame. Please ensure that if Sponsor/CRO approval is needed for updated budgets, this confirmation is sent to the IRB accompanying the updated compensation language request. In the event the IRB does not receive language/notification that there will be a compensation update, the site(s) will be issued a revised ICF containing the previously approved compensation language. In the event the site identifies they need their compensation updated after the amendment has been issued and released to the site, they will need to fill out a Change in Research form and request review of a revised ICF.
By checking this box, I acknowledge I have read this statement in regards to updated compensation and understand if the Sponsor/CRO/Site does not provide the updated compensation within the above outlined time-frame, it will require a separate review/fee.
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
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
What are the community attitudes towards the conduct of research in the area around this site? / Neutral
Positive
Negative
Are there any state or local laws where the research will be conducted that would impose stricter requirements for research than those posted by the regulations? / *Yes No
*Describe the stricter requirements and cite the law:
Does a local IRB have jurisdiction over the research at this site?
If yes, please have the local IRB provide a completed IRB Reliance Agreement Form. If this site is covered by a Master Services Agreement (MSA) or is a member of our Global Research Network (GRN), you may check “No”. / *Yes No
Which of the following best describes this site’s function?
College/University / Dialysis Center / Hospital / Medical Office
Nursing Home / Psychiatric Institution / Research Clinic / Other
Does this site have all the emergency equipment, personnel, and procedures required by the protocol?
Yes / No / Emergency procedures are not applicable to this research
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
Request To Enroll Vulnerable Populations That Were Not Previously Disclosed/Approved / N/A
Indicate the subject populations that will participate in this research. Select all that apply. Note: Individuals from these populations may not be enrolled unless checked.
Adults unable to consent
Children
Children that are wards of the state
Neonates who are not viable
I confirm the following statements are true:

• Individuals engaged in the research will have no part in determining the viability of the neonate
• Vital functions of the neonate will not be artificially maintained
• The research will not terminate the heartbeat or respiration of the neonate

Neonates of uncertain viability
I confirm the following statements are true:

• Individuals engaged in the research will have no part in determining the viability of the neonate

Pregnant Women
I confirm the following statements are true:

• No inducements, monetary or otherwise, will be offered to terminate a pregnancy
• Individuals engaged in conducting the research will have no part in any decisions as to the timing, methods, or procedures used to terminate a pregnancy
• Individuals engaged in conducting the research will have no part in determining the viability of a neonate.

Prisoners
I confirm the following statements are true:

• Parole Boards will not take into account a prisoner’s participation in the research in making decisions regarding parole.

Other Populations
Limited English Skills
Institutionalized Individuals
Students or employees of Investigators
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: 23 February 2018Page 1 of 5