Coordinating Centers

Overview

The term ‘Coordinating Center’ (CC) covers a number of very different research-related activities that range from a data center focused on the aggregation, management, and analysis of data from multiple sites, to a study-wide center responsible for overseeing all aspects of a multi-site study, including the development of consent forms, the preparation of a ‘manual of operations’, the coordination of data collection, and the overall governance of all research activities at all sites. Because the nature of these activities may vary from study to study, depending in part on the design of the study and the type of funding mechanism (e.g., cooperative agreements may differ significantly from program projects), it is critically important that investigators accurately describe to the IRB exactly what their responsibilities are – as detailed in the grant application or contract. It is the expectation of the IRB that those serving as a coordinating center will have adequate resources and expertise to carry out these responsibilities and have processes in place to ensure appropriate oversight. Most coordinating center applications receive expedited review but it is possible that a full board review may be needed, depending on the nature of the coordinating center responsibilities. Note that coordinating centers are not interchangeable with single IRB review. If Pitt will be the IRB of Record or if Pitt will cede IRB review to another institution, contact the Reliance Team (irb.reliance@pitt.edu)

Description

Listed below are examples of possible responsibilities that should be considered. Only include those activities in your IRB application for which the PI of the coordinating center is assuming responsibility. As previously stated, review your contractual agreement or grant scope of work to determine which activities are the responsibility of the CC and which are responsibility of the local site, site IRB, or other study-related centers (since large scale multi-site studies may distribute different ‘coordinating’ responsibilities to different programs. The following is not an all-inclusive list, but it provides descriptions of activities most commonly seen in CC applications.

Possible General Coordinating Center Responsibilities

Selecting appropriately qualified study sites and principal investigators, and providing study-specific training to research teams
Collecting and maintaining critical documents from affiliated investigators, e.g. resume/CV, medical license, certification of completion of training, laboratory certifications and laboratory norms, signed COI disclosure forms, etc.
Ascertaining that each protocol is reviewed and approved by the IRB at the collaborating institution prior to enrollment of participants at that site
Ensuring, if the study is federally funded, that each collaborating institution holds an applicable OHRP-approved Federal Wide Assurance (FWA)
Designing and developing the protocol, template informed consent documents, case report forms, manual of operations, etc.
Managing data and statistical analysis
Protecting the confidentiality of data during collection, transmission, and storage
Ensuring informed consent is obtained and documented from each participant in compliance with federal regulations and local IRB approvals
Registering participants, tracking participant enrollment, and coordinating randomization
Tracking, reporting and maintaining documentation of all serious adverse events and unanticipated problems and disseminating the information to sites
Providing periodic updates to affiliated investigators on participant enrollment, general study progress, and relevant scientific advances
Assuring that all relevant IRB correspondence (continuing review and amendments) and study status changes are communicated to all sites
Documenting receipt, shipment and storage of study specimens, drugs and/or devices
Auditing and monitoring, on a periodic basic, at the external sites to assess research study progress and compliance with the IRB approved protocol
Securing compliance at external sites that are not adhering to the current version of the research protocol and/or good clinical research practices
Terminating the involvement, if necessary, of non-compliant investigators and reporting such action to the IRB

Possible Data Coordinating or Statistical Center Responsibilities

This type of application places emphasis on how the PI will assume responsibility for collection, storage, management and statistical analysis of data collected. In most cases, this type of center application can be reviewed through an expedited process.

Designing data forms
Providing instruction on use of the forms
Managing data and statistical analysis
Overseeing secure data transmission and storage
Protecting confidentiality of data and ensuring its integrity

Considerations

If the University of Pittsburgh is acting in the capacity of both a coordinating center and as a site enrolling subjects, two separate protocols must be submitted to the IRB -- an application that outlines the responsibilities of the coordinating center and an application that describes the activities of the University or UPMC site. In general, if only two sites will be participating, the IRB may not require a coordinating center application be submitted (contact the IRB Office before creating the application).

It may not be necessary for a multi-site project to have a coordinating center application associated with it if all research procedures are being conducted by the same University/UPMC investigators. For more information, contact the IRB.

If it is a multi-centered, federally funded study, single IRB review may be required. Contact the IRB Reliance Team (irb.reliance@pitt.edu) immediately. The Pitt IRB can serve as the IRB of Record or will cede IRB review to another institution.

If the study involves a University-based, investigator-initiated IND or IDE clinical investigation at an external site, prior approval is required by IND and IDE Support (IIS).

If the study involves international sites, all documents in a foreign language must also include an English translation.

IRB Application

Coordinating Center Supplement

PittPRO does not have a separate Coordinating Center pathway. Instead, users must complete the Coordinating Center Supplement (A-Z Guidance) in order for the IRB to understand the roles and responsibilities of the coordinating center. The completed Supplement is to be uploaded in PittPRO, Basic Information #8.

Consent Document

If the Pitt PI is responsible for the design and development of the multi-site template, the template must be uploaded into PittPRO, Basic Information #8. If the Pitt PI does not have that responsibility, the consent form should not be included in the Coordinating Center but instead in the site protocol.

Adding New Sites

Once the IRB has approved the Coordinating Center application, you must create a Modification in PittPRO for additional sites. Check "External Sites" on the Research Sites page and complete/upload the required information and documentation.

Modifications

If the Coordinating Center holds the responsibility for protocol and/or consent template development, Pitt IRB approval must be granted before distribution of therevised materials to the sites.

IRB Review of Coordinating Center Applications

Since coordinating centers are most typically responsible for administrative aspects of the study, they usually involve no direct interaction or intervention with study participants. For that reason, the principal risk is a potential breach of confidentiality.
When the IRB reviews a general coordinating center application, depending on the center’s stated responsibilities, the IRB must determine and document that the center has a sufficient plan in place to ensure:

Program management, data analysis, and data and safety monitoring processes are adequate, given the nature of the research involved
Sample protocols and informed consent documents are developed and distributed to each collaborating institution
Each collaborating institution holds an applicable OHRP-approve FederalWide Assurance (FWA) if the study is federally funded
Each protocol is reviewed and approved by the IRB at the collaborating institution prior to enrollment of participants at that site
Informed consent is obtained from each participant in compliance with federal regulations
Any substantive modification by the collaborating institution of sample consent information related to risks or alternative procedures is appropriately justified

When the IRB reviews a data coordinating or statistical center application, depending on the center’s stated responsibilities, the IRB must determine and document that the center has a sufficient plan in place to ensure:

The privacy of participants and the confidentiality of data are adequately maintained
Each protocol is reviewed and approved by the IRB at the collaborating institution prior to transmission of data