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Determining Which “Study Questionnaire” to Use

Demystifying differences between central studies, single site studies, multiple single site studies, and investigator generated studies.

Quorum receives many different types of studies from sites, institutions, sponsors, and contract research organizations (“CROs”). While all studies are reviewed and processed by Quorum Review in the same way, the information Quorum needs to collect at the time of submission is different. In order to collect the correct information for submission, Quorum categorizes studies into several different submission categories: “central studies”; “single-site studies”; “multiple single-site studies”; and “PI-generated studies”. Since these categories are sometimes confusing for researchers, we do our best to explain the differences below.

Central Studies. A “central study” is a multi-site study for which the sponsor/CRO works directly with Quorum to coordinate IRB review. In other words, Quorum acts as the central IRB for the study. The FDA has acknowledged that it is acceptable for a sponsor/CRO to work directly with an IRB (see, “Guidance for Industry; Using a Centralized IRB Review Process in Multicenter Clinical Trials” [March 2006]). The central study submission option is now the most common type of submission at Quorum. For centralized studies, Quorum asks the Sponsor/CRO to complete Quorum’s “Central Study Questionnaire” (“CSQ”) as well as submit a model consent form. Each site then submits (either themselves or through a CRO) a “Site Information Questionnaire” (“SIQ”). This arrangement can also be used for a study with just one site.

Even when Quorum acts as a central IRB, Quorum maintains a direct relationship with the site. At the time of initial site submission, for example, the principal investigator must sign the SIQ and acknowledge that Quorum Review is the IRB for the study. As the study proceeds, it is especially important that Quorum communicate directly with the site should any issues arise with the site’s conduct of the study.

Single-Site Study. A “single-site” submission is appropriate for a sponsored research project that is being conducted at just one site. The single-site submission is also used by sites participating in a multi-site study for which no central IRB is selected. Finally, the single-site arrangement is used when a site is participating in a multi-site study and the site chooses to use Quorum instead of the central IRB designated by the sponsor/CRO.

When the principal investigator (PI) or study coordinator wants to work directly with Quorum for IRB review and services, we ask the researcher to submit Quorum’s “Single Site Study Questionnaire” (“SSSQ”) as well as Quorum’s “Site Information Questionnaire” (“SIQ”). Both forms should be submitted at the same time along with a consent form and a copy of the protocol. For a single site submission, the site works directly with Quorum to coordinate IRB review and the site acts as an intermediary for any communications between Quorum and the sponsor.

Multiple Single-Sites. Sometimes multiple sites in the same study will choose Quorum and these multiple sites will submit paperwork on a “single-site” basis. Please note that overall this approach is more expensive and less efficient. Nevertheless, Quorum is happy to manage multiple sites in this manner if this is the best option for the organizations involved.

Under this submission category each PI/site is treated as a separate customer; Quorum interacts with each site independently and maintains the confidentiality of each site. Each site is expected to submit protocol-level information independently, including updated protocols, investigator brochures, and IND Safety Letters. When Quorum is managing a study as a multiple single-site study, Quorum’s does not process information submitted by one site on behalf of another.

Principal Investigator-generated Protocols. Quorum will also review protocols that are developed and sponsored by independent investigators. Quorum does not currently accept protocols in which the principal investigator is the sponsor and also is proceeding under an IND (investigational new drug application). We understand that at times a PI-generated study might receive funding from a pharmaceutical company or other sponsor, and in those situations we will work with the investigator to determine whether the study should be considered a sponsored study or a PI-generated study.

Quorum requests additional paperwork for PI-generated protocols, including the “Principal Investigator Generated Study Questionnaire” and an indemnification agreement. Please contact Customer Relations for assistance in submitting a PI-generated study.

If you have any additional questions regarding study types feel free to contact Quorum’s Customer Relations group at any time (customerrelations@quorumreview.com or 206-448-4082).