Regulatory Knowledge & Support

For studies at IU requiring single IRB (sIRB) review, our sIRB Project Managers can help you navigate the process. Studies that plan to use the IU IRB as the sIRB should provide information about your grant via REDCap as soon as possible before submitting your grant proposal. The IU IRB typically requires study teams to utilize our sIRB Project Managers if there are 3 or more external sites. Contact us for an sIRB Project Manager support estimate to include in your grant budget.

sIRB Project Managers serve as a liaison between all sites and the IU IRB to ensure efficient IRB review and document control for the project. Our sIRB Project Managers support multisite studies by managing site additions, facilitating IRB submissions, and distributing IRB approvals to participating sites.

Clinical research monitors play an important role in ensuring compliance and data quality. Investigators who hold an IND or IDE should have proper monitoring in accordance with FDA regulations and Good Clinical Practice (GCP) guidelines. While related to data and safety monitoring, a clinical research monitor serves a different, but key, purpose on study teams by providing in-depth routine evaluations.

Contact us for an estimate.

We offer assistance identifying the appropriate regulatory pathway for drugs and devices, including whether an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application is required. We also help investigators prepare these applications.

• FDA Resources Library
• Study Toolkit

We partner with IU’s Quality Improvement Office to provide tools and education to investigators who hold an IND or IDE.

K12 projects and Clinical & Translational Science (CTS) awardees must obtain Prior Approval from NCATS before initiating projects involving human subjects and vertebrate animals, and must submit a Research Performance Progress Report (RPPR) annually.

The Quality Assurance/Quality Control (QA/QC) Project Manager can help you navigate the process, conduct quality assurance of your submission from the IRB through NCATS review, and provide monitoring services for clinical trials. Email the QA/QC Project Manager.

Your study requires SRC review if:

• It also requires convened biomedical review (full board), or is considered flexible expedited categories 400(b) and/or 700(b), AND,
• It has not undergone a previous peer review process.
  • Peer review may include review of the protocol by an external funder, such as a federal agency or established nonprofit research foundation, or protocol development by a commercial sponsor, such as a pharmaceutical or medical device company.

SRC review with the Indiana CTSI is not required for studies that undergo SRC review within the IU Simon Comprehensive Cancer Center.

The Scientific Review Committee will review studies under these criteria:

• Objectives: Clearly stated specific aims aligned with well-defined end points and appropriate study design.
• Scientific Merit/Background & Rationale: Justification for conducting the study; results of similar or pilot data; current literature cited.
• Design: Clearly describes how stated objectives will be achieved; methods to acquire data; and strategies to overcome anticipated barriers. Addresses randomization, minimization of bias, patient follow-up, and blinding (if applicable).
• Eligibility Criteria: Specific inclusion and exclusion requirements; stratification factors (if applicable).
• Outcome Characteristics & Endpoint Definitions: Clearly defined primary and secondary endpoints and outcomes aligned with the stated objectives.
• Statistical Analysis & Sample Size: Appropriate and adequate study design statistical analysis plan. Prospective analysis plan, including sample size justification to achieve study objectives, and plans to minimize missing data.
• Data Management: Practices and procedures to manage data analysis, quality, cleaning, and storage.
• Principal Investigator & Study Site Qualifications & Resources: Has the necessary skills, experience, time, and resources to ensure that the study can be successfully completed, including identification of personnel to provide statistical computations and statistical expertise. A plan to register protocol with ClinicalTrials.gov.

The instructions in the IU IRB Protocol Template may facilitate protocol development that is aligned with SRC review criteria.