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Client Guidance: Change to Site Information
Overview
  • Use these guidelines to complete F-198, Change Request Form for Sites (CRFS). If you have questions, email . You may also call (206) 448-4082 or (877) 472-9883.
  • Please submit all documentation to Quorum Review Independent Review Board (IRB)at least two weeks prior to instituting the site change(s).Any change to the (approved) site study information must be reviewed and approved prior to implementation.
  • An incomplete form may result in delay of IRB review. Quorum may also close a CRFS if the client is unavailable to provide information that is required.
  • A fee may apply to the change request. Contact Quorum for information or review the price lists that are available at

Submission Options
Electronic*
Quorum’s OnQ Portal

*No signature required. / Paper/Hard Copy
Quorum Review, Inc.
1501 Fourth Avenue, Suite 800
Seattle, WA 98101 / Email

What changes are needed?
  • Review each section to identify the change request that you need to make. You may make more than one change request by selecting the check boxes.
  • Remember one change may necessitate changes to other information. For example, if there is a change in the Principal Investigator (PI), the primary facility or site may need to be changed as well.

Additional Forms and Information/ Attachments
For information that is requested by a specific question in a section, attach a letter of explanation or enter the explanation in the space provided on the form.
You may need to use one of more of the following forms to complete your request to change site information:
  • F-016, Institutional Jurisdiction Waiver Form.
  • F-031, Conflict of Interest Statement, Disclosure of Financial Interests and Mgmt Plan.
  • F-038, Additional Facility Site Information Questionnaire (AFSIQ).
  • F-039, Site Information Questionnaire.
  • F-101, Observational Registry SIQ (CV not required).
  • F-209, IBC Questionnaire.

Form Header
Please enter the PI’s name that is associated with the Protocol Number.If you are Completing Section 1 Change in Principal Investigator, use the (departing)PI’s name that is associated with the Protocol Number.
Section 1 Change in Principal Investigator (PI)
Use this section to submit a change in PI. Please provide the following:
  • A letter from the current PI explaining why he/she is no longer able to perform the role of Principal Investigator.
  • The (new) PI’s current dated (within two years) Curriculum Vitae (CV), describing education, and licensure, training, clinical, and research experience relevant to the study.
  • If the PI’s relevant research experience is not included in the CV, attach and submit other documentation.
  • If the PI’s CV (and other relevant documentation) has already been submitted for another study and it is up-to-date, the PI does not need to re-submit the CV/documentation.
  • If the research facility is using Quorum’s IBC services, provide the revised IBC Questionnaire.
As applicable tor audits that have occurred within the last three years, include the following:
  • Copies of all audit documentation issued within the past three years for the incoming PI.
  • Explanation for actions taken against the PI to suspend or terminate the PI’s license or research.
  • Explanation for PI’s suspension of oversight or termination by sponsor, Ethics Review Board, Institution, or other entity.
  • A completed F-031, Conflict of Interest Statement, Disclosure of Financial Interests and Mgmt Plan.
  • Explanation for training that has not occurred for research staff and key personnel at this facility regarding human research participant protection regulations.

Section 2 Change in Primary Facility
Use this section to:
  • Change the Primary Facility.
  • Confirm the Primary Facility address will appear on the Site Information and Consent Form.
  • Acknowledge that the new Primary Facility phone number will appear on the Site Consent Form.
As applicable, provide an explanation for any deviation to the following:
  • Product Storage.
  • Emergency Measures.
  • Privacy of Study Participants.
  • Confidentiality of Study Data.
If the research facility is using Quorum’s IBC services, provide the revised IBC Questionnaire.
Section 3 Primary Facility Business Name
Use this section to submit a change to the Primary Facility Business Name.
Section 4 Additional Research Facility Information
Use this section to submit a change to the following:
  • Add an additional research facility (new research facility or change of address).
  • Remove an (existing) additional research facility.
  • Change the business name or phone number of a current additional research facility.
As applicable, provide the following information:
  • Attach a separate sheet to remove another additional facility or to change the business name or phone number of an additional research facility.
  • F-038, Additional Facility Site Information Questionnaire (AFSIQ) for each additional site. If the research facility is using Quorum’s IBC services, provide the revised IBC Questionnaire.

Section 5 Business and Emergency Phone Numbers
Use this section to submit a change to the business hours telephone number and/or the emergency/after-hours telephone number.These phone numbers are listed on the Consent Form.
Section 6 Communication with Quorum
Use this section to submit a change to the Primary contact information.The Primary contact responds to questions or issues identified by Quorum.
Section 7 OnQ Client Portal Access
Use this section to submit a change to OnQ Portal Access:
  • Grant (provide) access to (name) for the protocol and/or additional Site protocols.
  • Remove access (name) to the OnQ Portal or the protocol.
To provide or remove access to additional protocols at this site, submit a separate sheet for (name) and include the Protocol and QR numbers.
Section 8 Shipping Preferences
Use this section to submit a change to the Shipping Preferences.
A site processing fee is charged if the Sponsor has not elected study-wide hard copy mailing. Contact your Sponsor with questions.
Shipping by USPS standard mail or alternative shipper is renewed at continuing review.
Submit a separate sheet with Protocol and QR numbers for additional Protocols at this site.
Section 9 Translated Consent Form (Request or Removal)
Use this section to submit a change request to enroll non-English speaking participants in a study or to communicate that you are no longer enrolling non-English speaking participants.
If you are no longer enrolling non-English speaking participates, identify (Indicate) the language/dialect and provide a reason.
Quorum contacts the Sponsor to approve a request to translate a Consent Form that has not been previously translated into the language/dialect.
Section 10 Compensation of Study Participants
Use this section to submit a change to compensation or reimbursement for study participants.
As applicable for compensation and/or reimbursement:
  • Participant compensation amount varies per visit: Submit a schedule specifying the number of visits, payment for each visit, and total potential compensation and / or reimbursement.
  • Total compensation is undetermined: Submit a letter of explanation or enter the explanation in the space provided on the form.
  • Participants’ reimbursement amount varies per visit: Submit a schedule specifying the number of visits, payment for each visit, and total potential compensation and / or reimbursement.
  • Total reimbursement is undetermined: Submit a letter of explanation or enter the explanation in the space provided on the form.

Section 11 Request to Use Unique Consent Forms
Use this section to request documentation of a unique Consent Form. The unique Consent Forum is a revision of the Board approved model Consent Form (Sponsor’s Consent Form).
A fee may apply to this change (if not covered by the Sponsor).
Email Quorum to request an electronic copy of the approved Consent Form if needed.
Submit the following:
  • Current Model Consent: Tracked electronic version with unique revisions (in Microsoft Word).
  • Documentation of Sponsor or Contact Research Organization’s (CRO) approval of the proposed unique Consent Form.
  • Rationale for each requested change.

Section 12 Facility Address Cited on the Consent Form
Use this section to add or revise the facility address citation on your Consent Form. All addresses cited on the Consent Form must be approved by the IRB.
Submit a separate a separate sheet to add or remove additional address citations.
Section 13 Institutional Jurisdiction Waivers and Institutional Authorization Agreements
Use this section for Institutional Jurisdiction Waivers and Institutional Authorization Agreements.
As applicable:
  • Complete CRFS Section 2 Change in Primary Facility.
  • Complete CRFS Section 4 Additional Research Facility Information.
  • Submit F-038, Additional Facility Site Information Questionnaire (AFSIQ).
  • Submit F-016, Institutional Jurisdiction Waiver Form.

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