{"id":501,"date":"2022-03-24T13:41:51","date_gmt":"2022-03-24T17:41:51","guid":{"rendered":"https:\/\/research.ncsu.edu\/administration\/?page_id=501"},"modified":"2026-02-20T14:17:45","modified_gmt":"2026-02-20T19:17:45","slug":"preparing-and-submitting-an-application","status":"publish","type":"page","link":"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/preparing-and-submitting-an-application\/","title":{"rendered":"Step 2: Preparing and Submitting an Application"},"content":{"rendered":"\n\n\n\n\n

Preparing to Submit<\/h2>\n\n\n\n

Before you submit an application through NC State\u2019s eIRB system<\/a> for review and approval, the study (or the study portion of the project) must be completely designed. This includes identifying all research participants including third parties<\/em>, designing all research procedures, and uploading all required supplemental documentation (e.g., human subjects research training<\/a>, consent materials<\/a>, procedures for each data collection mode, and other materials that are required for review, e.g., exemption request form<\/a>, OIT drafted data and access security plan (DASP)<\/a> et al). <\/p>\n\n\n\n

DASPs are required for all protocols that involve highly sensitive \u201cred\u201d data or ultra-sensitive \u201cpurple\u201d data, NIH funding, a data use agreement (DUA) such as NCDPI and NCERDC data, material transfer agreement (MTA) such as biospecimen transfer from a HIPAA covered entity, and select other cases. To request a DASP, the principal investigator must request a data and access security plan request<\/a> through the “Service Now Portal”. If a DASP is not required, researchers will detail their data management plan either in the exemption request form for studies that are eligible for an exemption determination or on the data security tab of the eIRB application. <\/p>\n\n\n\n

Human subjects research training is required<\/a> before IRB approval for anyone on the research team who’s involved in the recruitment process, consent process, implementation of interventions and other data collection processes, or analysis of identifiable or re-identifiable private data. At minimum, this is the principal investigator and the faculty point-of-contact supervising a student who will be doing these activities. Proofs of training completion should be uploaded to the IRB application for all NC State University research team members and all individual investigators. If the research protocol is cooperative in nature<\/a> and another IRB with an FWA number will oversee those collaborators, those individuals’ human subjects research training does not need to be uploaded because that IRB will ensure that the collaborator(s) have their training done. <\/p>\n\n\n\n

To be eligible to submit an IRB application to the IRB office, you must be eligible to serve as principal investigator (PI) on a project. All student submissions must be supervised and submitted by<\/em> <\/strong>the NC State faculty member guiding the student’s IRB application process, will be supervising the student through the human subjects research process once the protocol is approved, and who is ultimately responsible for the human subjects research work.<\/p>\n\n\n\n

Infrequently, it\u2019s necessary for studies to be submitted in phases or stages; please follow the NC State IRB guidance for phased and staged research<\/a> if needed.<\/p>\n\n\n

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