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 firstname.lastname@example.org
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.
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.
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.
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.
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!
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!!
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.
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.