Chattanooga Research Forms and Resource Links
The UTCOM IRB has transitioned to a new online submission platform, IRBNet. New and subsequent submissions must now be submitted through the new program portal. Instructions on how to register, link your CITIT Training and make submissions as well as updated document checklists are located on the IRB Guidance and Policy tab.
For initial submissions, please be aware, the initial application exception request HIPAA and delegation log have been combined into one smart form. You will need to click on the Start Wizard tab under the Designer tab once you begin entering a new project.
All other forms are located in the Library tab along with consent form templates and other documents required for initial and subsequent submission. The FORM J (QI/AQ) has now been combined with the request for Non-Human Subject Research Determination.
- UTCOMC Grant Request Form: To be submitted (with detailed project & budget) to seek grant funding
- UTHSC Contract Certification Form: Investigator confirmation of contract terms, obligations, etc.
- UTHSC Routing Sheet: Cover sheet to accompany all grant/research submissions
- Graphics Request Form: Request for poster or other research display; IRB approval number required for human subject research or case study
- Case Report Consent Form
- Department Research Review Form 2011.9.7: Department/Program Approval prior to SRC/IRB submission
- Erlanger Radiology Research Collaboration Form 20119: Request for Erlanger radiology services to be used in research (i.e., x-ray, nuclear medicine, mammography, fluoroscopy, MRI, DEXA, CT, ultrasound, interventional radiology)
- Erlanger Pharmacy Research Collaboration Form: Request for pharmacy services to be used in research (i.e., storage, blinding, randomization, dispensing of investigational drugs)
- Erlanger Pharmacy Investigational Drug Service Fees-2017: Set up and maintenance fees for Erlanger pharmacy services
- 2018 Medicare Clinical Research Check Off: Checklist of required documents to submit for Medicare Coverage Analysis
- 2011.9 Medicare Coverage Analysis: Required to confirm that a trial qualifies for Medicare to cover reasonable and necessary items and services
- 2018 Clinical Research Billing: Determines what services are delivered to patient while on clinical trial, who will provide the service, who should be billed
- Erlanger Investigator Agreement - Rev 09/2015: Contract language between an investigator and EHS for all prospective trials conducted at Erlanger (including trials that involve only standard of care)
- Erlanger Clinical Research Master Agmt UTCOMC, 2012.4.3: Contract language between UT and Erlanger to conduct research
- E-Signature Certification: Agreement between Erlanger and FDA allowing e-signatures
- Clinical Trials Gov ACT Checklist: Checklist to determine if Investigator Initiated Trials meet the definition of "Applicable Clinical Trial" and require registration on Clinicaltrials.gov
- Research Submission Timeline: Overview of research submission process
- Erlanger Research and Billing Flowcharts: Overview for the UTCOMC and EHS IRB and contracting process
- UTCOMC Protocol Deviation Algorithm: Overview for timely reporting of protocol deviations, protocol violations, and serious adverse events; see Form I in IRB Forms
- Scientific Review Committee Proposal Format: Outline of project requirements for submission and presentation to the SRC
- 2022 IRB Membership List: List of IRB members, specialty, and affiliation
- 2021 IRB Membership List: List of IRB members, specialty, and affiliation
- 2020 IRB Membership List: List of IRB members, specialty, and affiliation
- IRB Policies and Procedures: UTCOMC Institutional Review Board policies and procedures
- Erlanger's FWA: Erlanger's Federalwide Assurance for the Protection of Human Subjects
- Tools for Multi-Site Research: Resources and tools used in other research networks covering collaborations, proposal development, study start-up, study conduct, study closure, and resources for training
- Quality Improvement Guidelines: Quality Improvement (QI) Projects and IRB Review
- Federalwide Assurance for the Protection of Human Subjects