Glossary of Terms and FAQ for Researchers

A Confidentiality Disclosure Agreement (CDA) is a legally binding contract entered into by the site and Sponsor which maintains the confidentiality of the study protocol and any study related information provides to the site and/or Principal Investigator by the Sponsor. A CDA may also be referred to as a non-disclosure agreement or secrecy agreement.

If the institution has a previously negotiated master CDA with the sponsor or CRO, it is not necessary to submit a new CDA for each study. Submit new CDAs to Industrial Relations at racontracts@llu.edu or call 909-558-4831 if you have any questions.

A Clinical Trial Agreement (CTA) is a legally binding contract entered into by two or more parties involved in the conduct of a clinical trial or registry study. The contract serves to outline the rights, obligations and restrictions of the parties. A CTA may also be referred to as a Clinical Study Agreement.

The CTA, along with the budget, informed consent forms, and the protocol should be submitted by using our Online Submission Form on our One Portal Page. There you will also find Tip Sheets to assist you with your submission.  You can also call our office at anytime 909-558-5830 or x55830.

No, an authorized Institutional Official is required to sign all agreements per Institutional Policy. The Clinical Trial Center will be responsible for acquiring this signature. An agreement signed solely by the Investigator is not enforceable or valid.

The Indirect Cost Rate for clinical trials is 30%.

If you receive a check, please make a copy of the check and retain it for your records. Deliver the check and all information received with it directly to the financial office managing the study’s account.

Yes. Always.

Your study is a clinical trial if it meets the institutional definition: "A clinical trial is a prospective research study involving interaction with human subjects and clinical intervention to evaluate the safety or efficacy of a treatment or diagnostic modality. Treatment may include drugs, devices, and biologic or surgical procedures."

The CTC provides support for cooperative group and industry-sponsored human studies including:

• Behavioral
• Database (Registries)
• Diet and Nutrition
• Exercise
• Observational
• Tissue Banking

For an Industry Sponsored Clinical Trial, please submit the CTA, budget, informed consent forms, and the protocol by using our Online Submission Form on our One Portal Page.  For a Non-Clinical Trial, please submit the protocol and the budget (if any) using the Online Submission Form.  There you will also find Tip Sheets to assist you with your submission.  You can also call our office at anytime 909-558-5830 or x55830.

If the clinical trial is industry-sponsored, standard practice is the sponsor registers the study with ClinicalTrials.gov.

The principal investigator may register the study with ClinicalTrials.gov if designated by a sponsor, grantee or awardee, so long as the PI is responsible for conducting the trial and has sufficient data rights. In addition, the PI is responsible for registering all investigator-initiated clinical trials with ClinicalTrials.gov.

If you have any additional questions, please contact the Clinical Trial Center at 909-558-5830 or x55830.

• Feasibility analysis
• Budget development and negotiation
• Medicare coverage analysis
• Ancillary support and billing facilitation
• Financial management
• Management of administrative linkages among LLU research stakeholders
• Marketing and liaison services with external sponsors

Please submit the Study Closure using the Online Submission Form.  The CTC will review the Clinical Trial Agreement for your study and determine whether or not there are specific provisions within the Agreement that outline how to terminate a study early. The CTC will offer guidance upon review.

Learn more by sending an email to irb@llu.edu or by calling ext. 44531.

Yes, all CDAs/NDAs must be reviewed by Industrial Relations to make certain the Institution is not assuming unreasonable liability, to verify appropriateness of legal terms, and to ensure that the document is compliant with Institution policies. Please be aware that CDAs/NDAs can appear in many different ways, such as in a letter form or even as an initial site questionnaire. When in doubt, contact Industrial Relations at 909-558-4831.

Yes. All research-related patient stipends that exceed the current year’s non-taxable limit must be reported to the IRS and are subject to be taxed as an additional income. The patient (or other recipient) will receive a 1099 from LLUHC Finance for the total amount of stipends received within a given calendar year, only if it exceeds the non-taxable limit. Based on IRS guidelines, research stipends are considered to be “Non-Employee Compensation” and could be a taxable income.

Yes. Medicare Coverage Analysis is used to determine the Medicare eligibility of the study based upon Medicare guidelines and a complete review of the protocol to determine which of the clinical “events” mentioned within the protocol can be reimbursed by Medicare. Since clinical research often takes place concurrently with routine care, it is important that billing is handled in accordance with applicable legal requirements. In addition, because most third party payors follow Medicare rules for coverage, institutional policy requires that MCA is performed whether or not the study enrolls Medicare patients (see LLUAHSC policy H40). For more information, please contact the Clinical Trial Center.

It’s very important that the billing offices receive notification within 1 business day of you consenting a patient. This step assures that the patient will not be billed for any research related activity that may occur as part of the screening process. It also assures that the study records will accurately reflect the number of patients consented to a study.

Yes. It is important that the CTC be notified when a patient screen fails. Screen failure may be a reimbursable item. Your notification is the trigger for such reimbursement as well as the removal of the research flag in the medical record.

An Informed Consent Template is available on the Research Affairs website. It is highly recommended that investigators thoughtfully revise the content provided by sponsors and follow the Research Affairs template as a guide to include the appropriate text and information required by LLU.

Yes. See the LLU Equipment Inspection Form on the "Tools and References" section of our One Portal page for more information.