Office of IRB Administration (OIA) Multi-Site Study Communication Plan Version Date: 09/06/2023
Detailed instructions are included for each section. All italicized instructions must be removed, and all sections completed. This document can be used when the UCSD IRB serves as the single IRB (sIRB) of record or as a template for studies using another IRB as the sIRB of record.
STUDY TITLE
Enter the project title here. Be sure it matches the title in Kuali IRB.
2. NAME OF IRB THAT WILL BE sIRB OF RECORD
Include the name of the IRB that will serve as the sIRB of record for this study and review for all US sites engaged in the research.
3. PARTICIPATING SITE AGREEMENT(S) FOR sIRB REVIEW
Indicate whether all participating sites in the study will rely on the above-named IRB as the sIRB of record. Indicate if there are any local legal requirements for review by more than one IRB (e.g. tribal law) or if the federal funding entity has granted an exception to the cooperative research requirement of the Common Rule for this study.
4. ROLE DEFINITIONS
There are four different point of contact (POC) roles. Depending on the size of the study, one person may fulfill more than one role. The following roles apply to this multi-site communication plan: REVIEWING IRB POC: Lead site contact person responsible for addressing questions from the reviewing IRB (i.e. sIRB of record) related to the reviewing IRB’s policies, procedures and review requirements for the study (e.g. lead site regulatory coordinator). LEAD STUDY TEAM POC: Lead site contact person responsible for facilitating communications between relying site study team POC and the reviewing IRB POC regarding this study. RELYING SITE POC: Relying site contact person responsible for communicating with the reviewing IRB POC, and relying site study team POC regarding this study (e.g. personnel in the local IRB office at the relying site). RELYING SITE STUDY TEAM POC: Relying site contact person responsible for communication with the lead study team POC regarding this study.
5. REVIEWING IRB POC NAME AND CONTACT INFORMATION
Include the name and contact information for the Reviewing IRB POC. Contact information should include at minimum a phone number and email address. Mailing address and fax number can be provided as applicable.
6. LEAD STUDY TEAM POC NAME AND CONTACT INFORMATION
Include the name and contact information for the Lead Study Team POC. Contact information should include at minimum a phone number and email address. Mailing address and fax number can be provided as applicable. ☐Lead Study Team POC is the same as the Reviewing IRB POC
7. COMMUNICATION TASK DEFINITIONS AND RESPONSIBLE POC
Use the table below to indicate which individual(s) will be responsible for defined communications. Any boxes with an * indicate boxes that must be checked if the UCSD IRB will be the sIRB of record for the study.
Communication Task	Responsible Point of Contact (POC)	Comments/Clarification
Closure report submissions: Providing the reviewing IRB with required information when a study is closed	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site ☐ Relying Site Study Team
Conflict of interest (COI): Providing applicable COI management plans for relying site study teams to the reviewing IRB	☐ Reviewing IRB ☐ Lead Study Team* ☐ Relying Site ☐ Relying Site Study Team
Consent form language: Incorporating site specific language into consent form(s) and providing these consent form(s) to the reviewing IRB	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site ☐ Relying Site Study Team
Consent form template: Providing the consent form template to relying site study teams	☐ Reviewing IRB ☐ Lead Study Team* ☐ Relying Site ☐ Relying Site Study Team
Continuing review information: Obtaining and collating study-wide continuing review information to the reviewing IRB	☐ Reviewing IRB ☐ Lead Study Team* ☐ Relying Site ☐ Relying Site Study Team
Continuing review submission: Submitting continuing review progress report to the reviewing IRB	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site ☐ Relying Site Study Team
IRB application – site specific: Preparing and submitting to reviewing IRB the site-specific applications and site-specific amendments that address site variations in study conduct, informed consent language, HIPAA privacy rule requirements, subject identification and recruitment processes (including recruitment materials), and any other applicable components of the research	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site ☐ Relying Site Study Team
IRB application – study wide: Preparing and submitting to the reviewing IRB the study-wide application, for initial IRB review, and subsequent study-wide amendments	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site ☐ Relying Site Study Team
IRB-approved documents: Providing copies of IRB-approved materials to the lead study team	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site ☐ Relying Site Study Team
IRB-approved documents – relying sites: Providing copies of the most current versions of IRB-approved materials to relying site study teams in a timely manner	☐ Reviewing IRB ☐ Lead Study Team* ☐ Relying Site ☐ Relying Site Study Team
IRB determinations: Providing documentation of IRB determinations to relying site study teams	☐ Reviewing IRB ☐ Lead Study Team* ☐ Relying Site ☐ Relying Site Study Team
Local context information: Providing local context information to the reviewing IRB regarding state laws and institutional requirements that pertain to the review of the ceded study	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site* ☐ Relying Site Study Team
Reportable event information: Obtaining and collating study-wide and site information for reportable events to the reviewing IRB POC	☐ Reviewing IRB ☐ Lead Study Team* ☐ Relying Site ☐ Relying Site Study Team
Reportable event submissions: Reporting reportable events to the reviewing IRB (e.g., unanticipated problem involving risks to subjects or others/unanticipated problem report (UPR), non-compliance, subject complaints)	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site ☐ Relying Site Study Team
Reviewing IRB policies: Providing relevant reviewing IRB policies to the lead study team	☐ Reviewing IRB* ☐ Lead Study Team ☐ Relying Site ☐ Relying Site Study Team
Study team training & qualifications: Providing confirmation to the reviewing IRB that relying site study teams have completed relevant training and are qualified to conduct the proposed research	☐ Reviewing IRB ☐ Lead Study Team* ☐ Relying Site ☐ Relying Site Study Team