Office of Research Advancement & Support (RAS)
Education and Classes
Research Matters is an enterprise-wide meeting that is held every 2 months, open to all research personnel in the AdventHealth Research Institute. Research Matters provides updates from our senior leadership, research service departments, and other information from research departments. If you would like to attend, but did not receive an invitation, please email FH.RAS@AdventHealth.com. Slides from previous research matters meetings are available to download at the bottom of the page.
If you see a class you would like to sign up for, email the RAS box at FH.RAS@AdventHealth.com with the class name and date and we can send you an invite to the class.
Onboarding Workshop Part 1 (Designed for all AdventHealth Research Institute employees, highly recommended for new hires)
- Why Research
- History of Research
- Research at AdventHealth
- Research Billing and Compliance Training
- IRB 101
- Research Resources & Tour of Research Websites
- HIPAA in Research
- Overview of the Research Study Submission Process
- Review & Wrap-Up
Onboarding Workshop Part 2 (Designed for anyone who is listed by name or supports someone on a Research Delegation Log)
- Responsible Study Conduct from start to finish and everything in between
- Study Initiation 101 (GCP, PI Responsibilities, etc)
- Informed Consent
- Scientific Misconduct
- Research Compliance
Onboarding Workshop Part 3a (Designed for Regulatory Needs)
- Research Personnel
- IRB Forms
- IRBnet Tagging
- Overview of Contracting
- Overview of Grants
Onboarding Workshop Part 3b (Designed for those working on Investigator Initiated Studies)
- PRE-Approval Study Topics
- Study Design
- Protocol Development
- Data Collection
- Data Safety Monitoring
- Case Report Form Development
Onboarding Workshop Part 3c (Designed for those working on Investigator Initiated Studies)
- POST-Approval Study Topics
- Data Quality Checking
- Data Mining versus Fishing
- Overview of Grants
Biostatistics and Epidemiology
Do you skip the statistics section when you read journal articles or protocols? Update your knowledge of statistical terms and gain confidence in reading those sections! Topics covered in this learning module include: sensitivity, specificity, reliability, validity, and odds ratio. After completing this class, you will have greater skill when critically reviewing published articles and information.
Do I need to register my study on ClinicalTrials.Gov? How do I do it? ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. This learning module will provide you with practical information that will help you decide if you need to register your study and a step-by-step guide of how to register.
Critical Article Review
This learning module will give you the skills to ask the tough questions about the research being presented and to be able to read between the lines to recognize what the article is and isn’t saying. This class introduces skills for critically reviewing published articles and information. Topics covered include: study limitations, data manipulation, statistical misdirection, omissions and conclusion interpretation.
IATA Dangerous Shipping Certification
Need to receive or update your IATA certification? This module fulfills IATA training requirements and qualifies you to handle and process dangerous goods by air for a 24-month period.
Would you like to have a better grasp of statistics when reading protocols and journals? What is the difference between a t-test, a correlation, and a chi-square test? How do I know what a good p-value is? This class will introduce the basics of statistical testing to better enhance your knowledge of Statistics in research. Different types of graphical displays will be reviewed, such as Bar Charts, Histograms, and Scatter Plots. No research or statistical background is needed for this introductory class!
Sample Size and Statistical Power
How many subjects do I really need in order to answer the research question? Isn’t n=100 a good round number to aim for? Gain an understanding of how different components of your protocol, patient population, and potential variables can affect your sample size and statistical power. Examples of calculations are demonstrated interactively using web-based statistical software.
- 2017.01.10 Research Matters
- 2017.03.14 Research Matters
- 2017.06.20 Research Matters
- 2017.09.25 Research Matters
- 2017.12.14 Research Matters
- 2018.02.20 Research Matters
- 2018.05.14 Research Matters
- 2018.07.17 Research Matters
- 2018.10.01 Research Matters
- 2018.12.06 Research Matters
- 2019.02.28 Research Matters
- 2019.04.25 Research Matters
- 2019.06.27 Research Matters
Research at AdventHealth has contributed to many publications. Listings of our publications by year is available for downloading at the bottom of this page.
AUTHORSHIP: A tool for helping research teams determine authorship can be downloaded below. The "Worksheet for Identifying Investigators and Authorship" can be used to increase transparency in research and to reduce confusion about authorship.
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 ClinicalTrials.gov with the contact information for your PRS Administrator.
- Contact your PRS Administrator, Shelley Watson (at FH.RAS@flhosp.org), 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 ClinicalTrials.gov, and review your record entry before it is released for publication on the ClinicalTrials.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.
- Please see the Clinical Trials ACT_Checklist guide below for more information on whether you need to register your study.
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.
Please see the attachments below for more information about Biospecimen Guidance.
- AH Internal Biospecimen Transfer DIAGRAM
- AH Internal Biospecimen Transfer Document - ADDENDUM Fillable
- AH Internal Biospecimen Transfer Document - ORIGINAL Fillable
- Biospecimen Research DIAGRAM 2016.08.30
- Biospecimens in Research - Synchronization Guidance Document 2016.08.30
- Contract Crosswalk for Sending Materials out for Analysis
Investigator Initiated Studies
AdventHealth encourages researchers to develop investigator initiated studies. Once a researcher has a research question, a research study can be planned to answer that question. A protocol is developed, which provides scientific background and a rationale to conduct the study. The research methods and procedures are described, including data collection. A statistical plan is outlined, which describes how the data will be analyzed to answer the research question.
One important concept in science is that of reproducibility. Research findings should be replicated by other researchers. The research protocol must contain sufficient detail to be reproducible.
To assist the researcher with writing a research protocol, templates have been developed for common study types. These protocol templates can be found on the Protocol Development tab as well as in the Forms and Template library in IRBNet at www.irbnet.org/release/index.html . The following protocols are available:
- Prospective Study
- Retrospective Study
*See the downloadable book below entitled "Registries for Evaluating Patient Outcomes: A User's Guide" which is an excellent resource for conceptualizing and planning Research Registries