Skip to main content
Department of Anesthesiology

Donate

Investigator-Initiated Study: Start-up Checklist and Resources

  1. Submit project summary or plan (Request Study Guidance) to UNC Anesthesiology Research
  2. Create PaTs investigator profile (Clinical Research Profile and Training System)
    a. Review and complete Attestation for SOP 301.1: Performing the Responsibilities of the Principal Investigator
    b. Review and complete Attestation for SOP 401 v2.0 (if applicable): Obtaining and Documenting Informed Consent from Adult Research Participants
  3. Complete Required Training (all study personnel)
    a. Collaborative Institutional Training Initiative (CITI)
    b. Conflict of Interest (COI) Training
  4. Conduct Feasibility Assessment
    a. Feasibility Assessment Overview
    b. Feasibility Assessment Checklist
  5. Develop Master Study Protocol
    a. Protocol Development Tips and Resources
    b. UNC Clinical Protocol Development Series
  6. Establish Data and Safety Monitoring Plan (DSMP) NC TraCS: Data and Safety Monitoring Plans
  7. Consult with NC TraCS Data and Safety Monitoring Board (DSMB) (if required)
  8. Choose data capture/data management system. It is recommended that UNC investigators use the HIPAA-compliant REDCap software system. REDCap at UNC is a secure HIPAA-compliant web application that can be used to build and manage case report forms, surveys and other data capture mechanisms for clinical research studies. The REDCap has detailed information, including,    additional requirements for data capture/data management with FDA-regulated studies.
  9. Submit Protocol to Scientific Review committee (SRC) (if required)
    Overview:
    What is the UNC Scientific Review Committee (SRC)?
    How Does the SRC Review Process Work?
  10. Submit study to UNC IRB and the Office of Human Research Ethics
  11. Create Protocol Record in OnCore, UNC’s clinical research data management system within five business days following IRB approval. As of August 2023, all clinical research that requires individual participant informed consent must be entered into OnCore. Request Study Guidance.
  12. Request UNC Health Investigational Drug Services, if applicable.
  13. If planning to distribute gift cards to participants, contact Anesthesiology Research to establish your gift card account.
  14. Register study in Clinicaltrials.gov. Details at: “Registering an Investigator-Initiated Clinical Trial” page.
    The University is a registered Sponsor at ClinicalTrials.gov and holds two separate accounts: one for oncology and another for non-oncology trials. Monica Coudurier (m_coudurier@unc.edu) from the Office of Clinical Trials, is the designated Administrator for the University’s non-oncology ClinicalTrials.gov account.
  15. Create Study Binder
    a. Regulatory Binder TOC
    b. Regulatory Binder Checklist
    c. Delegation of Responsibility Log
    d. Master Subject ID Log
    e. Enrollment Log Example
    f. Protocol Deviation Tracking Log
    g. Adverse Event Log
    h. Other Forms and Templates
  16. Train any personnel who will be conducting and documenting informed consent
    Obtaining and Documenting Informed Consent SOP
    Template Documenting Informed Consent Discussion and HIPAA Authorization