Regulatory Requirements & Approvals

• How do you register a clinical research project in Velos?
• How do you submit a research project for IRB approval?
• How do you obtain IND/IDE Sponsor Investigator Support?
• How do you register your trial on clinicaltrials.gov?
• What site approvals are needed to begin a study?

Several regulatory agencies oversee the research process to ensure the safety of research participants, review compliance with rules and regulations governing the conduct of research, and document study procedures before the conduct of study activities.

These approvals must be obtained prior to the conduct of any research activities involving participants.

Registering Your Clinical Research Project in Velos

Velos eResearch is a comprehensive electronic clinical research management system (CRMS) that allows monitoring of several aspects of clinical research involving study and participant management in a secured and HIPAA-compliant manner.

In addition to participant registration and electronic data capture (EDC) using electronic case report forms (eCRFs), Velos eResearch supports creation of study protocol calendars, coverage analysis, and creation of accurate budgets. Registering your clinical research project is a necessary first step to seeking IRB approval.

View Velos Tips and Training (link requires VPN).

Registering in PubMed Central

The National Institutes of Health (NIH) Public Access Policy ensures that the public has access to the published results of NIH-funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.

Because the CTSA Program is funded by the NIH, investigators who use any of its resources must register in PubMed Central.

Submitting Your Research Project for IRB Approval

All human subject research conducted by UT Southwestern faculty, staff, or students on behalf of UT Southwestern is overseen by the Human Research Protection Program (HRPP) Department. All review types require performance site approval.

Types of review processes and examples of research that fall under each type of review are:

• Non-Research (No IRB Review Required)
  • Quality improvement
  • Quality assurance
  • Health surveillance
  • Program evaluation
• Non-Human Research (No IRB Review Required)
  • Deceased subject research
  • Leftover, de-identified specimens
  • Commercial cell lines
  • Data/specimens from a repository (received de-identified)
• Exempt (HRPPO Staff/IRB Member Review Only)
  • Comparing/evaluating educational methods
  • Benign behavioral interventions
  • Secondary research with biospecimens and/or information
  • Surveys of adults
• Expedited (Designated IRB-Member Review)
  • Prospective clinical data and biospecimens
  • Non-invasive procedures
  • Surveys of children
  • Chart reviews not eligible for exemption
• Full Board (IRB Committee Review)
  • Greater than minimal risk research
  • Clinical trials
  • Any research use of radiation, anesthesia, or invasive procedures

The HRPP website has detailed instructions for submission of all research types.

Submitting an IND or IDE as a Sponsor Investigator

The Regulatory Support Office (RSO) of the Human Research Protection Program (HRPP) aids investigators and study teams with navigating complex regulatory requirements, including submission and ongoing management of investigator-initiated Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs).

Register a Trial on Clinicaltrials.gov

All “applicable clinical trials” are required to be registered in ClinicalTrials.gov, a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

Learn about required timelines for ClinicalTrials.gov registration and reporting.

For more information or to request support, visit HRPP’s Regulatory Support page.

Did you know?

The International Committee of Medical Journal Editors (ICMJE) requires registration of research studies, even when the study does not meet the definition of “applicable clinical trial.” Many medical journals require registration of a trial prior to data collection of the first study participant for publication of study results in their journal. The ICMJE website provides details on trial registration and data sharing requirements.

Determine if Your Clinical Research Project Requires Other Approvals

In many cases, approval by the IRB is only one step in starting your clinical or translational research project. For example, site approval by each hospital or clinic where the study will be performed or approval for use of ionizing radiation in research may be necessary before work on the project can begin.

It can take time to obtain needed information, and sometimes multiple approval processes are required, so it is helpful to determine what you’ll need as early in the planning phase as possible.