• Get assistance in Database/Informatics development
  • REDCap is the Data Capture system used by the University for Research. They system is IRB approved for research and the system is secured. The REDCap systems are managed by the OSCTR BERD core and Pediatrics BBMC Core and they are available to assist in project design. Learn more about REDCap here.
  • To get access into REDCap you must go to the REDCap main page and request access. To request REDCap support or sign up for a training session, email redcap@ouhsc.edu
  • See the OSCTR Research Resources on the BERD Core to learn more about their specific aims, the personnel, training and more. Here you can also fill out the online request for assistance from the BERD Core.
• Get assistance with recruiting study participants
  • Recruiting participants
    • OUHSC has an SOP for Recruitment into Research Studies. Please remember that any advertising that is done needs to be approved by the IRB before it can be dispersed. The methods in which you plan to recruit must also be disclosed an approved of (part of the IRB application). Any on campus advertising is done through the IRB.
    • Clinicaltrials.gov is used as a tool for patients to look up information about studies. Ensure that you have current contact information, accurate study description, and all important details about your trial.
    • Follow the OUHSC SOP on Internet and Social Media-Based Research for additional information on recruiting subject online and online studies.
  • Compensating study participants
    • Please review the OUHSC Participant Payment Policy to learn University requirement and methods for patient payment.
    • Patients must fill out the Participant Payment Request Form in order to be disbursed funds. Funds are not released to minors, so in the event that the study participant is a minor, the parent/legal guardian who signed the consent form must complete the participant payment request form (in the parent/guardian’s name)
    • Utilize the Participant Log to track patients and payment. Instructions/Examples can be found here.
    • The Participant Support Guidelines can assist in registering your participant as a vendor to be paid.
• Use available Core services
  • Please utilize the OSCTR for further service requests, if they apply to your needs. You are able to able to make these requests through the OSCTR Request Services Page. This will direct you to the iLab portal where you can submit requests. If you have not used iLab before, there is a tutorial video located on the OSCTR Request Services page.
  • ORA has a list of Core facilities for the campus. Additional information regarding these facilities is located here.
• Document your compliance with rules and regulations
  • University Compliance standard operating procedures
    • Please review all information on the Compliance Program organized by the OUHSC Office of Compliance. The purpose of the Compliance Program is to raise education and awareness, and monitor compliance with OU’s standards. This page includes links to several University Offices including Environmental Health and Safety, Radiation Safety, Healthcare Billing Compliance, Human Research Protection, Institutional Animal Care and Use, Institutional Biosafety, and Disability Resource Center.
    • OUHSC SOP For Investigators Qualifications and Responsibilities contains important information regarding what is expected of Investigators throughout the course of a study.
    • There is also an SOP for Sponsors for research studies that they must comply with
    • Investigators can always reference the Investigator Manual for Research Involving Human Subjects to ensure they are appropriately following OUHSC and Federal Guidelines. Check to make sure this is the most current
  • eIRB
    • Studies are maintained through iRIS where the IRB can manage changes, updates, deviations, and more. As indicated, all studies that require IRB approval will be submitted through the iRIS online portal. The IRB offers instructions from their IRB iRIS information page. Learn How to Connect to iRIS, iRIS Account Information, and iRIS FAQs.
  • Documentation management
    • The IRB has an SOP for Study Documentation Management which should be followed through the course of your research study. There is also an SOP for filing.
    • You will need to maintain a regulatory binder for your study. Items may include: screening and enrollment logs, drug accountability logs, temperature logs, delegation logs, con med and AE logs, Adverse Event/SAE logs, signed CV, 1572, Financial disclosures, Study agreements, IRB approvals, correspondence with collaborators, Notes to file, etc. The OSCTR Research Navigator can assist you in setting up your study. Be sure to include Modification Summary Report, Protocol Deviation Summary Report, and Summary of Participant Harms Reports, as they will need to be submitted to the IRB at the continuing review.
    • The FDA also has guidelines for source documents that are compliant with Industry GCP that may be helpful while you are organizing your study.
  • Approval for changes in study conduct
    • Whenever changes are made in your study (ex. Changes to the protocol, changes in who is working on your study, increase in number of participants, new ICF, etc.). Review the SOP for Modifications provided by the IRB. Once you are prepared to submit your Modification in iRIS, follow the instructions given by the IRB in How to Submit a Modification. Remember that any changes in your study can not begin until your modification is approved by the IRB!
  • Adverse events and protocol deviations
    • Please refer to the SOP on Protocol Deviations and Unanticipated Problems for how to deal with Adverse Events, which may qualify as Unanticipated Problems. Utilize this log for tracking deviations, which will be submitted to the IRB.
    • Serious Adverse Events should follow the SOP for Serious Adverse Event Reporting as well as the Reporting Policies for Reporting to Regulatory Agencies. A Log should be kept of these patient harms. If events are serious they should be reported in iRIS right away. If they are not, then keep the log and submit at continuing review. Find timeline for reporting AEs/SAEs/Deviations!!
  • Continuing review
    • The IRB will perform a Continuing Review on each study that remains open. The intervals that these are performed at will be determined by the IRB based on the content and specifics of your study. The SOP for Continuing Review details specific policies, criteria, outcomes, process, responsibility, and more. The IRB also provides a guide for How to Submit a Continuing Review.
  • Informed Consent and HIPAA
    • The IRB provides a Consent Form Guidance document explaining what an Informed Consent is and how is it used. There is also a PowerPoint that provides an in depth look at the Informed Consent. Also, refer to the IRB’s SOP for Consent Process and Documentation.
    • Additional guidance on informed consent.
  • Ethics of study conduct
    • Please see the Compliance Office’s Code of Ethics which contains all University SOPs for human subject research. You can also review the Office of Compliance and the University Human Research Participant Protection (IRB) Website for further guidance.
    • State laws for Research in the state of Oklahoma. These laws should be reviewed by individuals involved with research so that practices are followed according to state law.
  • Research Subject Advocacy
    • Under development
  • Radiation safety
    • Reference the Radiation Safety Office for details about radiation safety
  • Animal Protections
    • The Institutional Animal Care and Use Committee (IACUC) is responsible for overseeing research involving live vertebrate animals, and ensuring that researchers adhere to university and federal regulations. An overview is provided here along with announcements, reporting for concerns on animal welfare, contact information and OUHSC USDA Certificate Number and OLAW Assurance Number. You must be an authorized user to see additional web content, so there will be a prompt to enter your OUHSC username and password. As an authorized user, you will have access to view the Protocol Review Process, Policies Procedures and Guidelines, Hazards, Training, Occupational Health, and more. The Normal Campus provides details on Training for Vertebrate Animal Users.
  • Institutional Biosafety Committee (IBC)
    • The IBC reviews and approves all biological safety in research activities involving “recombinant and synthetic nucleic acid molecule, gene transfer including transfer to humans, microorganisms, viruses, and biological toxins.
  • Shipping biological samples
    • If your study involves shipping of biological materials, please ensure that the individuals responsible have the proper training and that policies as described in the Shipping Biological Materials manual provided by the Environmental Health and Safety Office at the University of Oklahoma are followed.