Clinical Research

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.

Contents

Defining Clinical Research

Understanding the types of clinical research helps the University determine which processes, templates, terms, and requirements that apply.

Clinical Trial

A clinical trial is 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.

Industry Sponsored Clinical Trial

The UW defines an industry-sponsored clinical trial as:

A human subjects research study whose primary purpose is to assess the safety and/or efficacy in humans of a drug, device, diagnostic, treatment, preventive measure, or similar intervention through testing of the intervention on patients in a clinical setting.

Industry Sponsored Clinical Trials use the 27% Total Direct Cost rate and base. If the study purpose is collecting information on treatment performed under standard-of-care, the UW does not consider that to be testing an intervention for safety and/or efficacy in a clinical setting. Such studies would use the organized research F&A rate.

Review more information on Getting started: eGC1 Review & Approval.

Federally Funded Clinical Trial

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 ClinicalTrials.gov (CT.gov), these clinical trials are called applicable clinical trials.

Some federal sponsors have specific proposal & award requirements that must be followed. For example see NIH Clinical Trial guidance.

Investigator-Initiated Trials / Studies

An investigator-initiated study (IIS) is a study developed by the UW Investigator and can be a clinical trial or clinical study, depending on whether there is an intervention. If a trial, the UW will serve as the sponsor as that is defined in 21 CFR Part 312.3(b). The external party is providing funding, or resources (e.g. study drug), or both.

There are some narrow circumstances in which the investigator-initiated study is non-human subjects research. For instance, a company may be interested in funding an investigator-initiated study that involves use of samples in a biorepository.

Clinical Study

A Clinical Study (or observational study) may involve activities similar to a Clinical Trial, but a study is intended for generalized knowledge, not treatment of a patient/subject’s condition, or intervention in their treatment.

Compassionate Use or Single Patient Emergency Enrollment

Review the UW Human Subject’s Division guidance on Single Patient Emergency or Compassionate Use.

There are two emergency situations that require expedited handling:

• Compassionate Use
• Single Patient Emergency Enrollment

New Emergency Care clinical trials: route a non-award agreement eGC1 and include a comment indicating “this includes Emergency Care” enrollment.

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.

Use the New Study Submissions REDCap Survey

While not required prior to routing an eGC1, OSP highly recommends the study team use the Study Submission REDCap intake form first. Benefits of using this survey include:

• Determines if study entry into the OnCore Clinical Trial Management System (CTMS) is required for sponsor invoicing purposes, which helps answer the related eGC1 question correctly.
• Creates an identifier number with the prefix “RG” that can be used in your eGC1 short title and helps link up records
• Helps identify whether CTO review for budgeting and billing purposes is required, and if so, to coincide with contract review

Getting started: eGC1 Review & Approval

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 New Study Submission RedCap Survey before submitting an eGC1 for the clinical trial agreement. Additionally, there are some administrative steps that can happen concurrently.

Pre-Clinical Confidentiality Agreement eGC1

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’s Non-Award Agreement (NAA) eGC1 instructions. Make sure to attach the sponsor’s CDA. If the sponsor wishes to enter into a Master CDA, review Master Agreement instructions.

If you need a confidentiality agreement, review the UW Approved Mutual NDA Sample Template. Using a UW approved agreement can speed up OSPs review process.

Review more information:

• Confidentiality / Non-Disclosure Agreements
• Non-award agreement eGC1 instructions
• Agreement Types
• Getting Started: eGC1 Review & Approval
• Master Agreement Instructions

Clinical Trial/Study Agreement eGC1

If the agreement includes funding, route an After-the-Fact eGC1.

If the agreement does not include funding, but the external party is providing a drug or device, route a Non-award Agreement eGC1.

Submit the following with the eGC1 and route to the Office of Sponsored Programs (OSP):

• Draft clinical trial agreement
• Draft clinical trial protocol
• Draft informed consent form (if available)
• Correct F&A rate used, if funding involved
  • Industry-sponsored clinical trial budgets must use the 27% F&A rate and total direct costs base
• Sponsor/CRO contact information
• SFI Disclosures – All investigators need to be listed on the eGC1 and complete their SFI disclosures via the UW Financial Interest Disclosure System (FIDs)
• If there is already a CDA, make sure to include the CDA eGC1 number on this clinical trial eGC1

Advance Spending

After OSP approves your clinical trial/study agreement eGC1, 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.

IRB Review & Fees

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:

• An independent IRB such as WCG IRB or Advarra
• The Cancer Consortium IRB (CC-IRB) operated by Fred Hutchinson Cancer Research Center (FHCRC)

IRB review fees and an HSD administrative fee may need to be included in the budget.

Review the UW Human Subjects Division information on:

• HSD Administrative Fee
• Do I need IRB Review?
• Is the UW IRB the right IRB?

Significant Financial Interest (SFI) Review Complete

The Office of Research must review disclosures for Financial Conflict of Interest before OSP can release the funding. The Office of Research also will determine if a conflict management plan is required.

Administrative Steps that can Happen Concurrently

Many of the required administrative steps can happen concurrently. These include:

• OSP can begin review & negotiation of the contract/agreement after you submit the clinical trial/study agreement eGC1
• Institutional Review Board (IRB) human subjects research review
• Clinical Trial Office (CTO) billing compliance review
• Significant Financial Interest (SFI) Disclosure review

Award Setup Requests & the Agreement

After OSP approves your clinical trial/study agreement eGC1, OSP creates an Award Set-Up Request (ASR) with basic information. OSP then begins review and negotiation of terms on the agreement with the external party.

Budget & Approval of the Budget Summary

The UW Clinical Trials Office (CTO) performs coverage analysis, creates the billing plan, and conducts compliance review. CTO may also develop and negotiate your clinical trial budget upon request. Using the Study Submission Institutional Intake REDCap form helps determine which studies must be entered into CTMS and undergo CTO billing review process.

Once the budget is finalized, CTO performs the Summary Review by confirming that the budget terms align with the billing grid, the ICF and the contract. Once review is complete, CTO sends the final billing grid and budget to PI, and the PI responds to CTO with their approval.

After the PI approves the budget & billing grid, the PI/study team must attach the following with the Award Setup or Modification request in SAGE:

• CTO summary review
• All summary review attachments
• PI approval of the budget as reviewed by CTO
  • Always include the final agreed upon draft budget and payment terms

If these are not attached to the Award Setup Request (ASR) or Modification (MOD) before OSP completes their review, OSP will return the ASR/MOD requesting these items.

OSP cannot approve the ASR/MOD and send to GCA for processing without these attachments.

This is also a good time to link a SAGE Budget worksheet that follows the instructions on Creating a Clinical Trials Budget for SAGE Awards Job Aid.

The OnCore Clinical Trial Management System (CTMS) handles generation of the invoices for these studies. OnCore is integrated with Workday so that once an invoice is generated in the OnCore CTMS, an invoice is generated in Workday, since Workday is the UW’s system of record. The OnCore CTMS and Workday Invoice integration automatically increases the award total, award authorizations, award line amount, and plan amount (which flows to the budget seen in the R1234 report) based on the amount of the invoice generated in OnCore. This integration between the two systems is why ASRs and MODs in SAGE are sent over with a zero dollar SAGE budget. The Department remains responsible for tracking costs and accuracy of invoicing based on the current terms.

PI signature on Clinical Trial/Study Agreements

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 “read and understood” ahead of OSP. 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 University of Washington.

Master Clinical Trial Agreements

The Office of Sponsored Programs has Master Clinical Trial/Study & Confidentiality Agreements with many companies and Contract Research Organizations (CRO).

Review the Master Agreement Instructions & the List of Master Agreements 

Abandoned Trials or Studies

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.

Steps to Secure Sponsor Payment for Abandoned Clinical Research

If abandoned after an ASR is created and still with OSP:

• Ask OSP reviewer to return the ASR because it is being abandoned and to discontinue any negotiations.
• Attach an email or letter from CRO or sponsor indicating the amount to be reimbursed and this commitment is from an authorized individual with CRO or sponsor.
• Link a SAGE Budget with minimal information and a “$0”.
• List the anticipated reimbursement amount in the ASR.
• Return to OSP.

If abandoned before an eGC1 has been created but expenses have been incurred:

• Route an ATF eGC1.
• Attach an email or letter from CRO or sponsor indicating the amount to be reimbursed and this commitment is from an authorized individual with CRO or sponsor.
• OSP will create the Award Setup Request and return it to campus for completion.
• eGC1 Budget section: indicate total reimbursement amount, no budget needed.

Generally, OSP does not sign an agreement to require payment for start-up costs ahead of CTA negotiations, in the event of a failed CTA negotiation.

However, if an agreement is recommended due to the start-up cost risk associated with the type of trial, please ensure the general fees/costs listed are consistent with budget guidelines from CTO and include the IRB fee. Please route the agreement on an NAA eGC1.

If an agreement is put into place, make sure to include the agreement eGC1 number on the clinical trial eGC1.

If the study is abandoned after a fully-executed CTA is in place, the CTA will have a budget/payment section which includes the Sponsor’s agreement to provide payment according to the budget that is incorporated. Termination language will require reimbursement for costs incurred for all services properly performed and non-cancelable obligations.

Agreement Amendments

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.

Remaining Balance on Clinical Trial Award?

Review GCA guidance on What if we have a surplus? Can we keep it?