Clinical research activities that fall under this definition of non-federal Sponsored Clinical Trials all route in SAGE and are processed by the Clinical Trials Office (UW CTO).
Have questions about a non-federal clinical trial agreement or amendment? Contact the UW Clinical Trials Office at uwcto@uw.edu.
Information here defines the variety of clinical research, guidance for initiating contract review, and the steps involved in getting clinical research started at the UW.
Understanding the types of clinical research helps the University determine which processes, templates, terms, and requirements that apply.
Funding for clinical trials is available from federal agencies. This funding may be through federal grant funding or contract. See federal sponsor requirements for more details. Federally funded clinical trials use the organized research F&A rate.
FDA regulated & NIH funded clinical trials have registration & reporting requirements. Information about them must be placed in (CT.gov), these clinical trials are called applicable clinical trials.
Some federal sponsors have specific proposal & award requirements that must be followed. For example .
All UW federally funded clinical trials are reviewed and approved by the Office of Sponsored Programs via SAGE.
Review the non-federal clinical trial definition and guidance on facilities & administration rate.
Review the UW Human Subject’s Division guidance on Single Patient Emergency or Compassionate Use.
There are two emergency situations that require expedited handling:
New Emergency Care clinical trials: route a non-award agreement eGC1 and include a comment indicating “this includes Emergency Care” enrollment.
Emergency Care Amendment to existing clinical trials: route an Award Modification (MOD) in SAGE for Emergency Single Patient or Compassionate Use enrollment. Include a comment to OSP indicating this MOD is for “Emergency Single Patient Enrollment” or “Compassionate Use Enrollment”. OSP will expedite review & handling of the request.
Clinical research agreements will often have two eGC1s, one for the pre-clinical confidentiality/non-disclosure agreement (CDA/NDA) and another for the study/trial agreement. We recommend using the y before submitting an eGC1 for the clinical trial agreement. Using the 鈥淩G鈥� prefix from the RedCap submission in your eGC1 short title to help link up records.
Have questions about a non-federal clinical trial agreement? Contact the UW Clinical Trials Office: uwcto@uw.edu.
Most sponsors involved in clinical research projects require a confidentiality agreement (CDA) before sharing protocols or other proprietary information.
When a sponsor asks you to enter into a CDA before the clinical study/trial agreement is set up at the UW, you need to follow the UW鈥檚 . Make sure to attach the sponsor’s CDA and on the eGC1, select the Sponsored Program Activity Type (SPA): Clinical Trial: Non-Federal (including industry sponsors).
If the sponsor wishes to enter into a Master CDA, follow the After-the-Fact eGC1 Process instructions.
If you need a confidentiality agreement, review the . Using a UW approved agreement can speed up OSPs review process.
Review more information:
After the clinical trial/study agreement eGC1 is approved in SAGE, you will not yet have an Award created in Workday. However, your project may be eligible for Advance Spend.
Review the SAGE Advances Overview. Getting an Advance set up in Workday will allow spending for start up costs before the award is finalized. It also helps if you need external IRB review or external vendor coverage analysis and have to provide HSD and/or CTO with a UW Worktag.
Human subjects research conducted by UW researchers must be reviewed by an Institutional Review Board (IRB). Industry sponsored clinical research involving human subjects is reviewed by one of the following external IRBs:
IRB review fees and an HSD administrative fee may need to be included in the budget.
Review the UW Human Subjects Division information on:
The Office of Research must review disclosures for Financial Conflict of Interes before funding can be released and spending can begin. The Office of Research also will determine if a conflict management plan is required.
For all clinical trial/study agreements, the PI is responsible for the conduct of the trial, including ensuring that the consent form, clinical trial agreement, and trial budget are consistent with each other regarding who is paying for what (procedures, subject injuries), and who will have access to the identifiable data.
Once the agreement is finalized, the PI must sign the agreement as 鈥渞ead and understood鈥� ahead of the UW Authorized Signature. The PI is representing that the final contract language is consistent with the approved consent language, among other terms set out in the agreement.
PIs are not authorized to sign on behalf of the 糖心原创.
The 糖心原创 has Master Clinical Trial/Study & Confidentiality Agreements with many companies and Contract Research Organizations (CRO). Review the list.
Need to request a Master Agreement? Review instructions for the After-the Fact Process.
From time to time, a trial or study is abandoned after start-up costs have been incurred. This happens when we are selected as a site but either the sponsor does not move forward, the UW chooses not to be a site after all, or some other reason prevents us from moving forward.
Depending on what stage a clinical research award is in when it is abandoned, there are different steps you need to follow to be reimbursed by the sponsor.
If abandoned after an ASR is created and still with OSP:
If abandoned on an unprocessed ASR (not set up in Workday):
If abandoned before an eGC1 has been created but expenses have been incurred:
Changes to a clinical trial agreement do not require another eGC1.
Submit a Modification request following the guidance available for Award Changes on Industry Sponsored Clinical Trials.
Review GCA guidance on