CURRENT STUDY INFORMATION / PRINCIPAL INVESTIGATOR
Sponsor / Protocol Number(s)
Principal Investigator / Quorum Review Number
Site / Center Name / Phone
Name of Person Completing Form / Date
TYPE OF CHANGE REQUESTED
Check all change requests that apply.
See G-038, Change to Site Information Guidelines for information that is requiredto complete this form.
Submit this page along with the following:
- Corresponding completed sections
- Required attachments or explanations
Section 1 Principal Investigator (PI)
Section 2 Primary Facility
Section 3 Primary Facility Business Name
Section 4 Additional Research Facility Information
Section 5 Business and Emergency Phone Numbers
Section 6 Communication with Quorum
Section 7 OnQ Client Portal Account Access
Section 8 Shipping Preferences
Section 9 Translated Consent Form (Request or Removal)
Section 10 Compensation of Study Participants
Section 11 Request to Use Unique Consent Form(s)
Section 12 Facility Address Cited on the Consent Form
Section 13 Institutional Jurisdiction Waiver And Institutional Authorization Agreement
SECTION 1 PRINCIPAL INVESTIGATOR
(a)Departing Principal Investigator
First Name / Middle Initial / Last Name / Suffix:
Medical License #(s) / State(s) / Provinces(s) / Expiration Date(s)
Sponsor / Protocol Number / QR#
(b)Attach a letter of explanation regarding circumstances of transfer of responsibility.
(c)New Principal Investigator
Check this box if you do notwant to include the investigator or study information in Quorum’s site directory.
First Name / Middle Initial / Last Name / Suffix
Medical License #(s) / State(s) / Provinces(s) / Expiration Date(s)
Principal Investigator Email
(d)Information About the New Principal Investigator
Has the Principal Investigator been audited or received disciplinary action by a sponsor, Ethics Review Board, Institution, or other entity?
NOSkip to “(h) Potential Conflict of Interest.”
YESPlease answer the questions below.
(e)Has the FDA, OHRP, the Canadian Ministry of Health, or other regulatory agency audited this study’s Principal Investigator only within the last 3 years?
NO
YESAudit(s) have occurred.
Copies of all audit documentation (such as Establishment Inspection Reports, Form FDA 483s, warning letters and corresponding investigator responses) issued within the last 3 years must be included with this submission.
Check all that apply.
Documentation is attached for audit(s).
Documentation is not yet available and will be submitted to Quorum as soon as available.
Documentation has been previously submitted for audit(s) dated: (MM/DD/YY)
(f)Has the FDA, OHRP, the Canadian Ministry of Health, or other local licensing authority ever taken action against the Principal Investigator, including issuing a reprimand, restricting his/her ability to conduct research, or placing conditions on or otherwise limiting his/her license?
NO
YES Attach a letter of explanation or explain here:
(g)Has research under the Principal Investigator’s oversight been suspended or terminated by a sponsor, Ethics Review Board, Institution, or other entity?
NO
YES Attach a letter of explanation or explain here:
(h)Potential Conflict Of Interest
Does the Principal Investigator, the Principal Investigator’s immediate family, the research staff, or the research staff’s immediate family have any financial or other relationship with the sponsor or other study-related entities that present or appear to present a conflict of interest?
NO
YES Attachcompleted F-031, Conflict of Interest Statement, Disclosure of Financial Interests and Mgmt Plan.
SECTION 1 PRINCIPAL INVESTIGATOR (CONTINUED)
(i)Human Research Participant Protection Training
New Principal Investigator Experience
Does the new Principal Investigator have clinical research experience with human subjects?
NO
YES
(j)Principal Investigator Training
Indicate the human research participant protection training the new PI has completed within the past 3 years.
Check all that apply.
Review of all the FDA Information Sheets, GCP Guidelines, and The Belmont Report.
Completion of the CITI Program: Course in the Protection of Human Research Subjects (available through Quorum Review).
Completion of the National Institutes of Health (NIH) Training: NIH Clinical Center Clinical Research Training or NIH Office of Extramural Research Protecting Human Research Participants Training.
Completion of other seminar or on-line training specific to human research participant protection.
Completion of self-study specific to human research participant protection (check all that apply):
Investigators Meeting
Clinic/CRO/SMO Training
Other. Describe or identify course/title, e.g., web Based HRPP training:
(k)The new PI has not completed any training on human research participant protection.
This will be addressed through the following.Check all that apply.
Investigators Meeting
Clinic/CRO/SMO Training
Other. Describe or identify course/title, e.g., web Based HRPP training:
(l)Staff Training
Quorum requires that research staff and key personnel at this facility have been trained and are aware of their obligations with regard to human research participant protection regulations.
If this training has not occurred, attach a letter of explanation or explain here:
(m)Research Resources
Enter 0 (zero) as applicable.
Indicate the number of research staff the new PI will supervise for this study.
- Number of sub-investigators:
- Number of Clinical Research Coordinators:
- Number of Other staff (such as RNs, regulatory specialists, technicians):
Indicate the number of research studies the new PI is currently conducting:
- Number of research staff the Principal Investigator currently supervises:
- Number of research facilities the Principal Investigator currently supervises:
- Approximate number of active research participants from all studies:
SECTION 1 PRINCIPAL INVESTIGATOR (CONTINUED)
(n)Check all that apply and attach applicable form(s).
Local Jurisdiction Issue / Attachment (forms available at quorumreview.com)
One or more of the study activities will be conducted in a facility that is under the jurisdiction of another Ethics Review Board (for example, an MRI performed at a local university). / If not previously submitted:
- Quorum Review Institutional Jurisdiction WaiverForm OR Institutional Cover Page (if available)
- Completed F-038, Additional Facility SIQ
Another Ethics Review Board or Institution (hospital, university, or other institution) maintains jurisdiction over the Principal Investigator and this research (for example, the PI is on the faculty of a local university). /
- Quorum Review Institutional Jurisdiction Waiver Form OR Institutional Cover Page (if available)
I am aware that this protocol has been previously submitted by this Principal Investigator or by this facility to any other Ethics Review Board for review. /
- Transfer of Jurisdiction Form – Site Level OR letter of explanation
I am aware of State, provincial, or other local laws governing research that impose obligations that Quorum should be aware of. /
- Description
- Copies of the applicable laws, if available
I am aware of local issues of note that may adversely impact the research conducted at this facility (recent or historic events related to research in this community, institutional features, etc.). /
- Letter of explanation
(o)PRINCIPAL INVESTIGATOR SIGNATURE*
By signing and/or submitting ting this form, I am confirming that the information is accurate and that I am the Principal Investigator (PI) or the PI’s designee. I am authorized to submit this form on behalf of the PI and the PI is aware of the information contained in this submission.
Principal Investigator (or Designee) Printed Name:
Title (For Designee):
Principal Investigator (or Designee) Signature / Date:
*A signature is not required if your site is submitting this form through the OnQ™ Portal.
SECTION 2 PRIMARY FACILITY
(a)Current Study Information / Principal Investigator
First Name / Middle Initial / Last Name / Suffix
Sponsor / Protocol Number / QR#
(b)Previous Primary Facility:
Address:
City: / State/Province: / ZIP/Postal Code:
Phone:
(c)New Primary Facility:
The phone number shown below will appear on your site Consent Form.
Address
City / State/Province / ZIP/Postal Code
Phone / Website if available
(d)Address(es) on Consent Form(s)
Use the primary facility address on the Information and Consent Form? / YES NO
(e)Information about the New Primary Research Facility. Check all that apply.
Administrative/regulatory activity / Informed consent discussion
Screening visit / Ongoing study visits
Specific procedures associated with study / Other (please specify):
(f)Describe this facility. Check all that apply.
Private/Group Practice / Hospital or hospital-affiliated
University or university-affiliated / Research-dedicated facility
Residential facility (please describe): / Other (please specify):
(g)Product Storage
Not applicable. This study does not include a study product.
I agree to put the following measures in place if the study involves study products (including placebo, approved drugs, or approved comparators):
- All study product(s) will be stored in a secure area; and
- Access to the study product(s) will be limited to authorized research personnel.
I will be deviating from these expectations. Attach a letter of explanation or explain here:
(h)Emergency Measures
Participant Emergency/After Hours Phone Number:
SECTION 2 PRIMARY FACILITY (CONTINUED)
(i)Indicate all emergency equipment/staff available at the primary research facility for a participant in need of emergency care. Check all that apply.
Crash cart / CPR certified staff / Emergency medications / Oxygen
Defibrillator / Access to 911 / N/A or Other (Please describe.):
(j) I agree to adhere to the following expectations in relation to emergency measures:
- A member of the study team or the PI will be available for participants 24 hours a day for any research involving a test article; and
- An individual that is not part of the research will be able to obtain information pertaining to the study when providing emergency care to participants.
(k)Privacy of Study Participants
I agreeto adhere to the following practices to safeguard the privacy of study participants:
- The site will consent participants in a private setting away from the public (if applicable);
- The site will provide barriers or a private setting if/when participants are required to disrobe;
- The site will not collect sensitive or personal information about a participant that is not necessary for the research.
(l)Confidentiality of Study Data
I agree to adhere to the following practices to maintain the confidentiality of study data:
- Paper study records will be physically secured (e.g., locked filing cabinets or rooms);
- Electronic study records will be protected with electronic safeguards (e.g., computer passwords, access privileges, firewalls, etc.);
- Participant identifying information will be protected from improper use and disclosure (e.g., coding/anonymizing practices);
- Confidentiality statements will be required of research staff;
- Access to study records will be limited only to research staff;
- The site will not use collected information for purposes other than the research purposes the participant has specifically consented to and authorized.
(m)Check all that apply and attach applicable form(s).
Local Jurisdiction Issue / Attachment (forms available at quorumreview.com)
One or more of the study activities will be conducted in a facility that is under the jurisdiction of another Ethics Review Board (for example, an MRI performed at a local university). / If not previously submitted:
- Quorum Review Institutional Jurisdiction WaiverForm OR Institutional Cover Page (if available)
- Completed F-038, Additional Facility SIQ
Another Ethics Review Board or Institution (hospital, university, or other institution) maintains jurisdiction over the Principal Investigator and this research (for example, the PI is on the faculty of a local university). /
- Quorum Review Institutional Jurisdiction Waiver Form OR Institutional Cover Page (if available)
SECTION 2 PRIMARY FACILITY (CONTINUED)
I am aware that this protocol has been previously submitted by this Principal Investigator or by this facility to any other Ethics Review Board for review. /
- Transfer of Jurisdiction Form – Site Level OR letter of explanation
I am aware of State, provincial, or other local laws governing research that impose obligations that Quorum should be aware of. /
- Description
- Copies of the applicable laws, if available
I am aware of local issues of note that may adversely impact the research conducted at this facility (recent or historic events related to research in this community, institutional features, etc.). /
- Letter of explanation
(n)PRINCIPAL INVESTIGATOR SIGNATURE*
By signing and/or submitting ting this form, I am confirming that the information is accurate and that I am the Principal Investigator (PI) or the PI’s designee. I am authorized to submit this form on behalf of the PI and the PI is aware of the information contained in this submission.
Principal Investigator (or Designee) Printed Name:
Title (For Designee):
Principal Investigator (or Designee) Signature / Date:
*A signature is not required if your site is submitting this form through the OnQ™ Portal.
SECTION 3 PRIMARY FACILITY BUSINESS NAME
(a)Previous Primary Facility or Business Name:
(b)New (Current) Primary Facility or Business Name:
SECTION 4 ADDITIONAL RESEARCH FACILITY INFORMATION
If needed, attach a separate sheet to remove or to change the business name or phone number of additional research facilities. (Please use the format below.)
(a)Add an additional research facility(new research facility or change of address).
Complete and submit F-038, Additional Facility Site Information Questionnaire (AFSIQ) for each site.
(b)Remove (existing) additional research facility. Facility is no longer in use.
This address will be removed from the Consent Form if currently cited.
Facility or Business Name:
Address
City / State/Province / ZIP/Postal Code
Phone
(c) Change the business name or phone number of a current additional research facility.
Previous Name of Research Facility or Business:
Address
City / State/Province / ZIP/Postal Code
Phone
Current Name of Research Facility or Business
Phone
SECTION 5 BUSINESS AND EMERGENCY PHONE NUMBERS
(a)Business hours phone number
(b)Emergency / After-hours phone number
SECTION 6 COMMUNICATION WITH QUORUM
(a) Primary Contact Name
Primary Contact E-mail
(b) Business Name for Mailing Address
Mailing Address / Fax
City / State/Province / ZIP/Postal Code
Phone
(c)PrincipalInvestigator E-mail
SECTION 7 ONQ CLIENT PORTAL ACCOUNT ACCESS
(a)Please provide access to the OnQ Client Portal:
For this Protocol.
For additional protocols at this site. Attach a separate sheet with Protocol and QR numbers. / Name
(b) Please remove access to the OnQ Client Portal:
Staff member is still employed by our company, however NO longer requires access for this Protocol
Staff member is still employed by our company, however NO longer requires access for additional protocols at this site.
Staff member has departed from our company.
Staff will be removed from the OnQ Client Portal for all Quorum Approved protocols for your company. / Name
SECTION 8 SHIPPING PREFERENCES
We request to receive all future documents from Quorum:
(a)Via the OnQ Portal at no cost.
Primary contact email
Via USPS standard mail or alternative shipper (as determined by the Sponsor).
Facility info below
Facility or Business Name
Address
City / State/Province / ZIP/Postal Code
(b)Please apply this change to:
Only this protocol.
Additional protocols at this site. Attach a separate sheet with the Protocol and QR numbers.
SECTION 9 TRANSLATED CONSENT FORM (REQUEST OR REMOVAL)
(a)We request to enroll non-English speaking participants in this study. / YES Language/Dialect
(b)Will you follow the expected safeguards noted below?
- I will ensure that a non-family member interpreter is available to interpret the informed consent discussion for the participant.
- I will ensure that all study-related materials are provided in a language understandable to the participant.
- I will use the translated consent form issued by Quorum Review.
(c)We are no longer enrolling non-English speaking participants in this study.
Indicate the Language/Dialect you are no longer enrolling and provide a reason.
SECTION 10 COMPENSATION OF STUDY PARTICIPANTS
(a)Will participants be compensated for participation in this study?
NO, participants will not be compensated for their participation in this study.
YES, participants will be compensated for their participation in this study
Check only one.
Fixed Amounts: $ per each completed visit for a total amount of up to $
Varied Amounts: Participant compensation amount varies per visit:
Please attach a schedule specifying:
- Number of visits; Payment for each visit; Total potential compensation
(b)If total compensation is undetermined (e.g., participant total will vary depending on which arm of the study a participant is randomized to), attach a letter of explanation or explain here:
(c)Please include information for any compensation for sub-studies and/or caregivers, if applicable:
(d)When will compensation be given to participants?
Check only one.
At each study visit.
After all participants complete the study.
After a participant’s final visit.
Other. Please specify.
(e)Will reimbursement for costs incurred, gift(s), study equipment(s), or other inducement(s) be given to participants?
NO, participants will not be reimbursed for costs or provided gifts, etc. for their participation in this study.
YES, participants may receive reimbursement for costs incurred, not including the compensation.
Check only one.
Fixed Amounts: $ per each completed visit for travel and parking expenses up to a total amount of $
Varied Amounts: Participants’ reimbursement amount varies per visit:
Please attach a schedule specifying:
- Number of visits; Payment for each visit; Total potential reimbursement.
(f)If total reimbursement is undetermined (e.g., participant total will vary depending on which arm of the study a participant is randomized to), attach a letter of explanation or explain here.
(g)Please also include information for any reimbursement for sub-studies and/or caregivers, if applicable.
(h)YES, participants will be offered gift(s) and/or study equipment(s) that will not be required to be returned upon study completion.
Describe gift(s) and approximate total value $ Description
Describe study equipment(s) and approximate total value $ Description
(i)When will reimbursement for costs, gifts, etc. be given to participants?
Check only one.
At each study visit.
After all participants complete the study.
After a participant’s final visit.
Other. Please specify.:
SECTION 11 REQUEST TO USE UNIQUE CONSENT FORM(S)
(a) Revise the model consent form developed by the Sponsor and approved by the Board. Site will pay the additional fee(s), if not covered by the Sponsor.
SECTION 12 FACILITY ADDRESS CITED ON THE CONSENT FORM
(a)Remove the address citation from the consent form; the facility is still in use.
(b) Add the previously submitted additional facility address citation to the consent form for the facility (below).
Facility or Business Name
Address
City / State/Province / ZIP/Postal Code
SECTION 13 INSTITUTIONAL JURISDICTION WAIVERS AND INSTITUTIONAL AUTHORIZATION AGREEMENTS
(a) New Primary Facility: Complete CRFS Section 2 Change in Primary Facility, submit any applicable document(s), and complete the section.
(b) New Additional Research Facility: Complete CRFS Section 4 Additional Research Facility Information, submit any applicable document(s), and complete the section.
(c) Previously IRB Approved Primary Facility Primary Facility Address
(d) Previously IRB Approved Additional Facility Additional Facility Address
(e)Check all that apply and attach applicable form(s).
Local Jurisdiction Issue / Required Attachment (if box is checked; all forms available at quorumreview.com)
One or more of the study activities will be conducted in a facility that is under the jurisdiction of another Ethics Review Board (for example, an MRI performed at a local university). /
- Quorum Review Institutional Jurisdiction WaiverForm OR Institutional Cover Page (if available)
- Completed F-038, Additional Facility SIQ
Another Ethics Review Board or Institution (hospital, university, or other institution) maintains jurisdiction over the Principal Investigator and this research (for example, the PI is on the faculty of a local university). /
- Quorum Review Institutional Jurisdiction WaiverForm OR Institutional Cover Page (if available)
I am aware that this protocol has been previously submitted by this Principal Investigator or by this facility to any other Ethics Review Board for review. /
- Transfer of Jurisdiction Form – Site Level OR letter of explanation
I am aware of State, provincial, or other local laws governing research that impose obligations that Quorum should be aware of. /
- Description
- Copies of the applicable laws, if available
I am aware of local issues of note that may adversely impact the research conducted at this facility (recent or historic events related to research in this community, institutional features, etc.). /
- Letter of explanation
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