The mission of the Investigator Support and Integration Services (ISIS) program is to facilitate clinical and translational research at OHSU and the Portland VA Medical Center. ISIS works with these institutional partners to streamline study start-up and management processes and related administrative and compliance processes and provide pre-award and regulatory services to investigators. ISIS administers the Human Subjects Protection Program of the Clinical and Translational Research Center (CTRC) to maximize the protection of human subjects involved in OCTRI projects. The OHSU Clinical Trials Office, a unit within ISIS, provides study start-up services and negotiation of contracts for OHSU industry-sponsored clinical trials.
Kitterman, Darlene, M.B.A.
Role: Program Director, Investigator Support and Integration Services
"OCTRI staff members can research personnel and procedural costs and develop a budget for projects to cover these costs. Investigators can request this service regardless of whether they plan to use OCTRI research services for the project.
In order to provide adequate budgeting services, investigators must submit their final research plan/protocol to OCTRI three weeks prior to their RGC grant submission deadline.
OCTRI Cost Estimates:
Investigators who plan to use OCTRI research services to start up or carry out a study should request a letter of support and cost estimate. Investigators must budget for OCTRI research services at the time of funding application.
The OCTRI Research Navigator Program will work with investigators to identify the services to be utilized and to develop an accurate cost estimate."
"Conducting research involving human subjects requires prior review and approval by an Institutional Review Board (IRB) and, potentially, additional institutional compliance committees. OCTRI can assist investigators navigate compliance requirements and are available to assist investigators in complete pre-study and ongoing IRB submissions.
OCTRI can assist with the following elements of the IRB submission process:
Complete the IRB application and other IRB related documents.
Write the consent form.
Write the HIPAA authorization form.
Work with investigator to respond to the IRB review summary in order to obtain full IRB approval.
Assist with development of the protocol that is submitted with the IRB application.
Assist with obtaining certificates of confidentiality.
OCTRI can assist with applications to the following compliance committees:
OHSU Institutional Review Board (IRB)
Portland Veterans Administration Medical Center
OHSU Knight Cancer Institute
OHSU Biosafety Committee
OHSU Radiation Safety Committee"
"A data and safety monitoring plan describes how the study will be overseen for subject safety and data integrity. Specific activities in a DSMP are determined by the complexity and risk of the study. OCTRI staff can help to draft DSMPs for grants, protocols, and Institutional Review Board (IRB) submissions.
A data and safety monitoring board (DSMB) is a group of individuals charged with oversight of the safety of subjects and data integrity in a study. OCTRI staff members can help investigators determine if their study needs a DSMB.
Developing a charter
"The Clinical Trials Office Contracting unit, also called CTO-Contracting, is responsible for negotiation of contracts (Clinical Trial Agreements) and associated agreements on behalf of OHSU for industry-sponsored clinical trials."
"When studies involve drugs or devices not approved by the Food & Drug Administration (FDA), or drugs or devices used for purposes not approved by the FDA which pose an increased risk, investigators are required to get clearance from the FDA prior to enrolling subjects in their study. OCTRI compliance experts have experience in determining whether a drug or device requires and IND or IDE and the expertise required to assist investigators submit INDs and IDEs.
IND – An investigational new drug application to the FDA is required for drugs not yet FDA approved and some uses of FDA-approved drugs for a non-FDA-approved purpose or population. ISIS staff help investigators determine if they need an IND and assist in requesting a determination from the IRB or the FDA. If an IND is required, ISIS staff can help investigators collate the information required for an IND.
IDE – An investigational device exemption allows investigators to use an investigational device in a clinical study. ISIS staff will help investigators determine if they need to submit an IDE to the FDA and, if so, can assist with collating information required for the IDE application."