The Office of Research Integrity (ORI) oversees the ethical and compliance aspects of research at FH.

  • The Institutional Review Board (IRB) reviews all research conducted at FH or by FH employees/agents to ensure ethical standards, scientific merit and regulatory compliance. The IRB’s primary responsibility is to protect those who volunteer to participate in research studies.
  • Research Billing Compliance and Education seeks to ensure that FH researchers use proper billing practices when billing services provided as part of a research study by conducting education, audits, and facilitating intradepartmental processes.
  • Responsible Study Conduct Compliance and Education is committed to ethically responsible research and good clinical practice. Consultations and audits are available as tools to enhancing the quality of research and the responsible conduct of research.

C&E Research Billing

The Research Compliance and Education (C&E) Program in Research Billing strives to provide Florida Hospital investigators and research staff with the information and resources for compliant research billing.  

If you have any questions, please contact us at FH.ORI@flhosp.org or 407-303-8793.

Please note these documents below will be updated frequently.  Please download the most recent version from this website each time you need to send notifications.  

C&E Responsible Study Conduct

The Research Compliance and Education (C&E) Program in Responsible Study Conduct strives to provide Florida Hospital investigators and research staff with the information and resources necessary to ensure that current good clinical practice, Institutional Review Board, and other regulatory requirements are met.  Many of the resources offered by the C&E Program are based upon the Partners HealthCare System, Inc. Human Subject Research Quality Improvement Program initiatives. Florida Hospital's Office of Research Integrity would like to acknowledge their contributions to the educational materials found on the Compliance and Education webpage.

 
Please take a moment and look at our additional pages:

  • Conflict of Interest (COI)
  • Institutional Review Board (IRB)

 
Please contact us at FH.ORI@flhosp.org or 407-303-8793.
 

ClinicalTrials.Gov

Registering your Project on ClinicalTrials.gov

How do I register on ClinicalTrials.gov?

  • Go to the “Request Contact Information” page, found at  http://prsinfo.clinicaltrials.gov/contactRequest.html
  • Enter “Florida Hospital” as the PRS (Protocol Registration System) organization account name
  • Enter your contact information.
  • Receive an email from CT.gov with the contact information for your PRS Administrator. 
  • Contact your PRS Administrator to set up a User Account for you.
  • After you receive your account login information, go to the login page at: https://register.clinicaltrials.gov/
  • After you log in, you will see a “Help” section containing links to instructions and informational documents including the following; “Quick Start Guide” and a “User’s Guide”. These documents will assist you with registering your trial.
  • After you enter your clinical trial information, your organization’s PRS Administrator will receive an email from CT.gov, and review your record entry before it is released for publication on the CT.gov site.
  • Within 2-5 business days after it is released, you can view the record including the unique identifier, National Clinical Trial (NCT) number. Once your clinical trial has an NCT number, you can modify it and add results.
  • For additional information, go to; http://prsinfo.clinicaltrials.gov/; and/or http://www.icmje.org/
     

Which trials have to be registered in ClinicalTrials.gov?

  • Interventional studies of drugs, biologics, and/or devices (NOT Phase 1 studies or small feasibility device studies) have to be registered as required by law
  • If you are conducting a study that is federally funded, it must be registered no later than 21 days after the first subject is enrolled.
  • Registration is required for journal publication.  The International Committee of Medical Journal Editors (ICMJE) has a clinical trials registration requirement for publication.

 
Who is responsible for registering the clinical trial?

The “Responsible Party” is defined as:

  • The Study Sponsor (IND/IDE holder, NIH Grantee, or the “initiator of the trial”), OR
  • The sponsor designated PI (PI responsible for conducting the trial, has access to and control over the data, has the right to publish the results, and has the ability to meet all of these requirements)
  • If it is a multi-site study, then the primary PI would be the responsible party for ensuring it is registered. It would only be registered once. It would not be registered by each individual site.

 
What is the ICMJE definition of a clinical trial?
In June 2007 the ICMJE adopted the WHO’s definition of clinical trial: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.