Welcome to the OSCTR Clinical Research Toolkit site. The site is currently in development, but we wanted to make it available to users to help facilitate researchers. We also welcome suggestions from users about features and information you would find helpful on the site. Over the next few months, we will be adding additional information to each category.
If you have suggestions for content, please send them to osctr.ouhsc.edu.
Use the Oklahoma Shared Clinical and Translational Resources (OSCTR) as a resource when initiating your study.
Request assistance from the OCTSI/OSCTR Research Navigators
Prior to starting a research project involving human subjects, you will need to submit your protocol to the Institutional Review Board for approval. This application is done through iRIS. A brief description on how to access iRIS is given here. The IRB application may require additional approvals from other committees, depending on the content of your study.
IRB—The Institutional Review Board (IRB) is responsible for reviewing research submissions that involve human subjects and assess that it adequately meets the criteria for approval set forth by the federal regulations, state law, and OU policies and procedures. All studies involving human subject research need to be submitted to the IRB for approval. If you are unsure if your study needs IRB approval, please submit a Determination of Human Research Form located in iRIS. Instructions on completion of this form are found here.
You will need several items prior to IRB submission. You will need a list of all personnel that will be working on the study and their duties, information regarding any outside collaborators (Including FWA number for their institution if applicable), your protocol, Informed Consent, HIPAA waivers, any additional study documents, and any other forms which you can review here.
Your Research Study may qualify to be Expedited or Exempt. Review the criteria to determine if your study meets these qualifications. If not, the study will go to the Full Board for review. Verify if these forms are up to date. If you have any question of whether your project is human research and needs to be submitted for IRB review, complete a Determination of Human Research Form found on
Here is a flow chart for the IRB Submission process. This helps in being prepared for study submission to the IRB.
Please review the IRB Education page for additional information regarding requirements (http://compliance.ouhsc.edu/hrpp/OUHSC/Education.aspx). Any personnel listed on the IRB must complete their CITI Training (uses OUHSC email account) and have completed or be registered to complete the in-house IRB training.
Please also refer to the HIPAA Compliance website to ensure you are diligent in following HIPAA Practices.
Other approvals may be required, depending on the type of study you are doing. If your study involves cancer, please complete the forms provided by the Clinical Trials Office on their Protocol Review Page. You will complete the Protocol Notification Form and the Protocol Review Form. You will need to include the protocol, additional grant or budget information, the Informed Consent, HIPAA and any other relevant documents. Once you receive the approval from the SCC you can submit to the IRB. Ensure you attach your approval along with your IRB Application.
If your study involves recruitment of patients at the VA Medical Center, you will need approval from the VA Research and Development Committee.
You also may require further approvals if your research incudes Radiation Safety, Institutional Biosafety, or if it is an Investigator Initiated study involving drugs or devices (will also need FDA Approval). Ensure that the study goes through the Office of Research Administration, if necessary.
Refer to the SOP on Emergency Use of FDA Regulated Products for instances for using test product on an individual in a life-threatening situation where there is no suitable treatment and no time to obtain IRB approval.
IACUC— The Institutional Animal Care and Use Committee is responsible for overseeing the University’s animal care and use program and reviewing all animal use protocols involving live vertebrate animals, ensuring compliance with federal animal welfare regulations, inspective animal facilities and investigator laboratories, investigating animal concerns, and overseeing training and educational programs.
Regulation decision charts that are useful in making decisions regarding your study.
Regulations and Policy Pages
Compliance and Reporting
Education and Outreach
Certificates of Confidentiality are documents issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. Certificates of Confidentiality allow investigators and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates can be used for biomedical, behavioral, clinical or other types of research that is sensitive and could adversely affect or damage a subjects' financial standing, employability, insurability, or reputation. Certificates of Confidentiality may be issued to any research study on a sensitive health-related topic that collects names or other identifying information even if the research is not funded by NIH. You can also reference the NIH site for Certificates of Confidentiality.
OUHSC Policies/SOP on the FDA—Refer to the University guide for the SOP on the FDA to ensure regulations are being followed appropriately.
Clinical trials guidance and information
FDA responses to questions on Good Clincal Practices. The areas are sorted by section the question pertains to, and then sorted by year.
Electronic FDA Submission guidance. This page offers guidance and additional links as well as answers to Frequently Asked Questions.
Drugs must have an approved marketing application prior to transfer or distribution across state lines. For trial drugs, they must obtain exemption from this law. This is done through the IND application. This page also discussed the types of IN and the IND Categories. If your product is a device you will have to go through the process for the IDE. Please also see the IDE Policies and Procedures.
The FDA guide to IND or IDE exemption. IND/IDE authorization or exemption must be obtained prior to drug or device being administered (and is not the subject of an approved New Drug application or License Application).
The FDA required a Form 1572 be completed for Sponsored Trials. Instructions for filling out this document are here. This form, along with other FDA forms can be located at the FDA site, here.
Patients may also have questions regarding research or treatment. They can refer to the FDA to learn about Expanded Access and Other Treatment Options.
Clinical trials must follow FDA Regulations. A listing of the Regulations is provided by the FDA on the FDA website.
Research studies may be required to be registered on clinicaltrials.gov. Their website has a helpful guide to help you determine if your trial should be registered. The International Committee of Medical Journal Editors (ICMJE) also provides additional answers to questions about clinical trial registration.
In order to register your trial you must first apply for an account at clinicaltrials.gov. Then you can follow the instructions on How to Register Your Study.
Other federal agencies have their own rules or regulations in addition to the Common Rule. These requirements have to be met when reviewing, approving and conducting research when supported by these agencies. Please review the SOP on Other Federal Agencies for specific regulations each of these other agencies may follow to ensure that your project meets all requirements.
Hold for GCA
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
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.
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.
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.
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.
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
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.
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.
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!
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!!
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 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.
HSC Consent Template
Consent Template –Tissue Banking
Patient Information Sheet—Tissue Banking
Consent Form Addendum
Child Assent Template
Sample Consent for Emergency Use
You will also need to follow HIPAA Guidelines and obtain HIPAA Consent. Information about HIPAA can be found on the HIPAA website.
Please use the appropriate HIPAA form that applies to your research
Form 1—Authorization to Use or Disclose PHI Used for most clinical research projects not involving psychotherapy or repository research
Form 2—Authorization to Use or Disclose Psychotherapy Notes for ResearchàInstructions here for preparing authorization for disclosure of psychotherapy notes
Form 3—Authorization to Use or Disclose PHI for Repository ResearchàFor Repository Research only
Form 4—Authorization to Use or Disclose PHI for Research that also Includes Repository ResearchàCombination of Forms 1&3. Used for Combined Research that includes Repository Research
Form 5—Request for Waiver or Altercation to Use or Disclosure of PHI in Research
Form 8—Investigator Representation for Research on De-Identified PHI
Form 9—Investigator Representation for Research on Limited Data Sets of PHI
Form 10—Data Use Agreement for a Limited Data Set
VA Form 10-0493—Authorization for Use & Release of Individually Identifiable Health Information for VHA Research
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.
Reference the Radiation Safety Office for details about radiation safety
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.
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.
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.
Review PI responsibilities for closeout
Make sure to complete the closeout form in iRIS to submit to the IRB.
Follow the University SOP on Documentation, Documents, and Data Management for regulations on how long records should be stored. This SOP also covers guidelines for VA studies.
Grants and Contracts offer assistance on Clinical Trial Closeout. The Clinical Trial Closeout Worksheet can be used to assist in final budget calculation.
Please review the Administrative Policies Section 574 (Clinical Trial Financial Policy for Sponsored Studies) for information regarding Facilities and Administrative Costs on Clinical Trials and Cost Accounting and Allocation of Expenses.
Review the Grant & Contracts Policies and Procedures to find the Sponsored Program Financial Reporting and Closeout Policy.
The HSC Writing Center may be able to provide assistance in writing your manuscript
Clinicaltrials.gov provides a document to assist in reviewing study results, and explains how clinicaltrials.gov can help review protocols and results to ensure validity, consistency, formatting, and more. Get further guidance here: https://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf
Ensure that you follow NIH Public Access Policy.
All publications with results from NIH-funded research must be submitted to PubMed Central and the PMCID has to be reported through NCBI. View the NIH Website about public access for more information.
Federal Funding Opportunities (Grants.gov)
In order to be approved by the IRB you must attend the in-house IRB training. Here is a list of the HRPP Education Program Materials that will assist you in being prepared for the day of your training. Register for training here.
Researchers also need to complete the CITI Basic Course. Instructions on registering are listed on the Research Involving Human Participants OUHSC Education Requirements Page.