Frequently Asked Questions
1. Where do I start?
- For clinical research studies, start by registering your project with the WVCTSI Clinical Trials Center of Excellence. The module has been updated to include clinical study agreements.
- For data use agreements, complete the DUA Submission Form in WVU+kc.
2. What is the difference between a clinical study and a clinical trial?
A prospective observational clinical study is defined as clinical research in which investigators assess outcomes on participants without the manipulation of the research participants.
To qualify as a clinical trial, the answer to each of the four questions should be yes:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
3. What is the NIH definition of a clinical trial?
NIH defines a clinical trial as: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. https://grants.nih.gov/policy/clinical-trials/definition.htm
4. Will these process changes affect Clinical Trials COE registration fees?
The registration fee will be waived for unfunded, investigator-initiated studies.
5. How should subawards and amendments be submitted?
For the time being subawards and amendments should be submitted to ClinicalStudyAgreements@hsc.wvu.edu.
6. What is a data use agreement?
A Data Use Agreement (DUA) is a legal contract between the entity that owns the data, typically a dataset or database, and a secondary entity that will receive the data (eg, sharing data with a collaborator at another institution).
7. Is a data use agreement needed to share data outside of the institution if my study isn’t a clinical trial?
In most cases YES. Contact us at DUA@hsc.wvu.edu for detailed guidance.
8. What is a CDA?
A CDA is a confidential disclosure agreement and it "is used to assure that a party receiving proprietary information (for example, "trade secrets") will maintain the information without disclosing it to others or using it in an unauthorized manner," as defined by the National Institutes of Health.
CDAs, Non-Disclosure Agreements (NDAs), or privacy agreements, are all legally binding contracts that protect and limit disclosure of information, data, or materials under evaluation by third parties.
9. How do I submit a CDA, NDA, or privacy agreement for review?
To submit a CDA/NDA, please use the following Qualtrics form. Based on your selection on the form, the results will be routed to the appropriate party. If you select that the agreement is related to clinical research, the Clinical Study and Data Management Office will be notified and begin work negotiating and executing your agreement. The link to the form can be found here Non-Disclosure Agreement Request Form (qualtrics.com)
10. What kinds of NDAs or CDAs will this office review?
Only disclosure agreements related to clinical research are under the purview of this team. When the initial Qualtrics form is submitted, and it is indicated to be clinical research, the form will be routed appropriately. Those not related to clinical research will be routed to Corporate Relations.
11. How should budget amendments be submitted?
E-mail the amendment as an attachment to ClinicalStudyAgreements@hsc.wvu.edu. Please include the following identifying information for the study:
- OSP number (if available)
- Amendment number
- Sponsor name
- Sponsor contact email address
- PI name
12. Is there a cross-training and/or back up plan in place as work load increases?
Yes. There are back-ups in place to support the team and our investigators as requests increase over time.
13. Are consultations available?
YES! Consultations on clinical study agreements and data use agreements can be directed to the email addresses listed below.