FAQs

The Forms page on our website contains many research administration forms you may need to submit a proposal. Contact your OSR staff if you cannot find what you need. 

Relevant UC, UCSF and sponsor policies are often noted on the specific webpage on the OSR site. Contact [email protected] to sign up for the OSR Announce Listserv for updates on processes, policies, meetings and other information.

The Institutional Information page includes much of the detail you may need.  For additional guidance, please contact OSR Staff.

Funding sources can be researched through COS/PIVOT, Grants.gov, FedBizOpps and a number of other federal and non-federal websites. Learn more on the UCSF Research Development Office's website. 

Search for your OSR staff support in the Find My Support section. 

A Material Transfer Agreement (MTA) or Data Agreement is needed any time a UCSF investigator sends or receives materials, samples, software, or data into or out of UCSF. The Industry Contracts Division (ICD) handles all incoming materials, outgoing human materials (i.e. blood, tissue, resected tumors, etc.), and all incoming/outgoing data.

For outgoing non-human material transfers (i.e. mice, modified cell lines, reagents, etc.), please refer the Office of Technology Management (OTM) website or e-mail [email protected].

When materials and/or data are exchanged in both directions, this should be treated as a collaboration. For collaborations with industry partners, please see the ICD Industry Collaborations page. For collaborations with other academic institutions or non-profits, please e-mail OSR.

Foreign Component is existence of any “significant scientific element or segment of a project” outside of the United States, in other words

performance of work by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended and/or performance of work by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended.

For Postdoctoral scholars that are required to work on their originally approved work remotely from a foreign country due to COVID-19 travel restrictions, where no grant funds are going to a foreign entity, NIH has determined this scenario does not constitute the performance of a significant element or segment of the project outside the US.  Therefore, this is not considered a foreign component and does not require prior approval. 

If project staff (including visiting faculty, scientists, etc.) leave the country to return home due to COVID-19 and continue to work on the project, whether paid by the project or not, this could qualify as a foreign component and would require prior approval from the NIH IC.

SOURCE: NIH NOT-OD-19-114, NIH COVID-19 FAQ

The recipient institution should evaluate the element of the project that is being conducted outside of the United States within the context of the project as a whole when making determinations about significance. Some examples of activities that may be considered a significant element of the project include, but are not limited to:

• collaborations with investigators at a foreign site anticipated to result in co-authorship
• use of facilities or instrumentation at a foreign site
• receipt of financial support or resources from a foreign entity

SOURCE: NIH FAQs

OSR staff will assist you throughout the proposal submission process.  Work with your OSR staff in order to obtain information on preparing and submitting a proposal through OSR. Note that your sponsor type and/or agreement type will determine which OSR team will provide support. 

The Institutional Information page includes much of the detail you may need.  For additional guidance, please contact OSR Staff.

According to the new Uniform Guidance [§ 200.463 (d) “Recruiting Costs” you may charge visa application fees to your grant provided the postdoc/researcher is critical and necessary for the conduct of the project. 

UCSF's negotatiated F&A rates should be used in most cases. The rate will depend upon the sponsor, project type and location. Learn more. 

The budget amount should be the Total Costs for the entire project period. 

Yes, even if there is no measurable effort, if the award supports the PI's research endeavors it must be included.  

OSR recommendation is to put “Effort as Needed*” in the table and then have an explanation below the table including that the effort will not exceed XX amount. Keep in mind PI effort should not be more than 12 months in the current year. Also include the statement “This sponsor funds the research but does not allow PI support and does not require PI effort”. 

Be aware different GMSs may require additional information or clarification. 

Example:

According to NIH's FAQs: For subprojects, recipients should provide the project number and PD/PI name for the overall project. All other information, including total award amount and person months, for the subproject only.

NIH does not provide guidance on how to report the effort if they are on more than one project.  OSR recommendation, is to have a separate column in the effort table for each Project/Core.  

NIH guidance states: PD/PI's need to provide person months of effort for the current budget period and indicate the proposed level effort for each remaining budget period.

OSR recommends 2 options:

Option1: Snapshot - For the current year, use a snapshot of what the effort currently is today.  If PI efforts remains consistent, then this a more simplified option.  However, if the PI effort fluctuate across different times of the year, it may incorrectly show a lower effort level.  Reminder, if the researcher is listed as Key Personnel in the NOA, then prior approval is required.  This may give a false impression that prior approval is needed even if over the course of the year they effort is not reduced by more than 25%.  

Option 2: Budget Period -- So for each award listed, calculate effort based on that AWARDS budget period.  The budget period will not be the same across the different awards.  This may prevent the problems that can occur with option 1 when effort fluctuate across the year.  However, because the dates vary, it makes cause the effort to appear to be over 12 CM because of the timing of when certain awards end.  It is important that if the effort for the current year (the first entry in each of the effort tables) adds up to more than 12CM that and Overlap statement is included that describes how it is not a commitment overlap.  For example, explain that the effort for Award Y is reduced for a few months until Award X ends.  

Either if the start date has already passed, or if the PI hears from the sponsor that it will not be funded.

No, subsumed effort is complementary effort and does not require prior approval but you do need approval for concurrent support. For more information go NIH GPS Chapter 12 (see 12.3.6.1 and 12.3.6.2)

The project costs for the whole project.  If this is a large project grant (for example a P50), list only projects/core that the faculty member work on, list the project costs for the project/core

NIH RPPR progress reports are uploaded to eProposal.  To find documents in eProposal follow the Finding Projects and eProposal Navigation guide (Must have an UCSF Myaccess account to view). Search by the A#. 

Submit the Other Support to your OSR staff.  OSR will submit to NIH.

For NIH, no. You only need prior approval for REDUCTIONS of 25% or more (if they are listed as Key Personnel in the Notice of Award).  If not NIH, please check the sponsor policy.

This is the new baseline of effort.  If you make further reductions, you need to ask for prior approval if you reduce by 25% of this NEW approved effort level. 

Keep it listed in the active section.  Put the proposed new dates and next to the dates, put in Parentheses, NCE Pending.

Example: 

R01 HL 0000002 (Anderson) (AXXXXXX)                                                   03/1/10– 02/28/16(NCE Pending)  5.60 calendar

Identify any scientific, budgetary, or commitment overlap that would occur if the current proposal were approved. Then state how it would be resolved.The goals in identifying and eliminating overlap are to ensure that sufficient and appropriate levels of effort are committed to the project; that there is no duplication of funding for scientific aims, specific budgetary items, or an individual’s level of effort; and that only funds necessary to the conduct of the approved project are included in the award.

Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salary) are requested in an application but are already provided for by another source.

Commitment overlap occurs when a person’s time commitment exceeds 100 percent (i.e., 12 person months), whether or not salary support is requested in the application. While information on other support is only requested for Senior/key Personnel (excluding consultants), no individuals on the project may have commitments in excess of 100 percent or 12 person months.

Scientific overlap occurs when: (1) substantially the same research is proposed in more than one application or is submitted to two or more different funding sources for review and funding consideration, or (2) a specific research objective and the research design for accomplishing that objective are the same or closely related in two or more applications or awards, regardless of the funding source. Potential scientific overlap is to be addressed by the SRG only by its identification in an Administrative Note in the Summary Statement.

Example 1:

There is commitment overlap for Dr. XYZ between 5R01WE1234546-01 and the application under consideration. If this application is funded Dr. XYZ will request approval to reduce his effort on 5R01WE1234546-01 to 2 calendar months. If other pending applications are funded, Dr. XYZ will reduce his effort appropriately. 

Example 2:

There is scientific overlap commitment overlap for Dr. XYZ  between aim 1 of 5R01WE1234546-01 and aim 2 of the application under consideration. If this application is funded, Dr. XYZ’s effort will be adjusted on 5R01WE123456-01 to remove the overlap.

As noted above, the Institute/Center’s scientific program and grants management staff will review other support information prior to award.

Resolution of overlap occurs at the time of award in conjunction with applicant institution officials, the principal investigator, and awarding agency staff. NIH staff continue to monitor changes to other support information throughout the project as part of the annual progress reviews.

Yes, the Ethics and Compliance website about Foreign Influence and Export Control. 

Yes, this is considered a “Conflict of Commitment” and certain categories of outside activities require prior approval.  PI should consult with their department chairs and/or use OATS (Outside Tracking System) to report activity. 

NOT-OD-19-114 indicates using Total Costs.

Yes, the department’s role is to ask faculty whether they are engaging with foreign entities for research purposes, and make faculty aware and direct them to appropriate offices.  Postaward and OSR staff are not expected to verify all information against other sources of information outside of the financial system. If a faculty member mentions that they have a collaboration with a researcher at a foreign institution, Postaward and OSR staff should consider whether the activity requires reporting to NIH as Other Support or a Foreign Component, and make the faculty member aware that they need to report.

The Foreign component should be part of the proposal, R&R Other Project Information Form,  not the Other Support document. The addition of a foreign component to an ongoing NIH grant continues to require NIH prior approval, as outlined in the NIHGPS, Section 8.1.2, Prior Approval Requirements.  Principal Investigator’s should work with their OSR staff to submit the prior approval request.

If an activity does not meet the definition of foreign component because all research is being conducted within the United States, but there is a non-U.S. resource that supports the research of an investigator and/or researcher, it must be reported as other support.

For example, if a PD/PI of an NIH-funded grant has a collaborator outside of the U.S. who performs experiments in support of the PD/PI’s NIH-funded project, this would constitute a foreign component, regardless of whether the foreign collaborator receives funding from the PD/PI’s grant. Additional funding from a foreign source for the NIH-supported research of a PD/PI at a U.S. institution would not constitute a foreign component but would necessitate reporting as other support.

One option is to list as "aggregated effort" for all Industry Clinical Trials.  List the information for each individual study and then have 1 effort table at the bottom that represents the aggregated effort.   Introduce the Clinical Trials section with the following statement:

"Each of these individual projects has a varying need of effort depending on the type of activity currently in progress:  protocol development, start-up, patient recruitment, enrollment, follow-up, monitoring, data analysis, publication, and closeout. Faculty determines each project's need and adjust their effort between projects within the total aggregated effort assigned to the clinical projects.  Effort is reviewed and confirmed by the department based on the activity of each project."

Example of Industry Sponsored Clinical Trials Entry for Other Support

This is determined at the time the subaward is proposed. If the subaward will cover actual costs and UCSF will reimburse the subrecipient for its actual costs, then the subaward is cost-reimbursable. If the project meets the definition of fixed rate from the NIH and the subaward is under an NIH award, then the subaward will be fixed rate. If the project meets the definition of fixed amount under the Uniform Guidance (2 CFR 200.1), then the subaward will be a fixed amount subaward. The SOW and budget/milestone payment schedule provide most of the information for making this determination.

Fixed Amount is defined in the Uniform Guidance at 2 CFR 200.1. Fixed Rate is an NIH term defined in the Grants Policy Statement at 8.1.2.11. Fixed amount is a predetermined amount for the activities performed. Fixed rate is a predetermined rate for an activity but the total number of that activity is unknown. Other federal agencies have not adopted that term; however, check the federal agencies applicable policies because they may have similar guidance. For example, the Department of Defense has a similar situation described under DOD General Terms and Conditions SUB Article XII Section B. View more Fixed Rate Guidance.

The Subcontracts Team prefers that the indirect costs be included in the fixed rate amount. No verification of the indirect rate is needed when the fixed rate amount is inclusive of indirects.

An amendment can include as much actions as needed. For example, if the amendment needs to extend the end date, change the subrecipient PI, and include a revised budget, all of the actions may be included in the one request form. Utilize the comments section to help clarify the intent of the amendment.

The Subcontracts Team tracks all of its transactions in CACTAS. Since May 2020, the Subcontracts Team has had its own record type. Some of the fields are specific to the Subcontract record type. Learn more about CACTAS and find guides for now to search and create views.

The Subcontracts Team needs the RAS Project ID when setting up new subawards/subcontracts because the “SC#” is created under a specific Project ID. Therefore, if the Department wants to track and manage the subawards under different Project IDs, then the Department will need to request these and have them setup prior to initiating the subaward request. Once the SC# has been created, the Subcontracts Team cannot move them.

For many requests we are sending out the subaward or amendment in less than 5 business days from receiving the request. Request forms submitted with a request to expedite will not be expedited. In order to have a subaward expedited, the request for expedite must be determined prior to submitting the request form. If the request is going through the Proposal and Grants Teams, the Assistant Team Manager and Team Manager will first review the request to ensure the request is reasonable. If the ATM and TM believe the request is reasonable, they will contact the Subcontracts Team Manager to discuss. This process can run concurrently to collecting the information for the request form. For all other requests, please send an email to [email protected] and the Subcontracts Team will discuss with the options.

Review the sponsor’s policies regarding effort. Subawards under federal flow through require the subrecipient PI to have measurable effort. For cost-reimbursable subawards, the detailed budget and justification will include this detailed information. For fixed rate/fixed amount subawards, the effort and commensurate salary are calculated into the fixed rate/fixed amount cost.

No unless the sponsor has provided pre-award spending and our PI has approved the subrecipient to pre-award spend. Otherwise dates that are outside of the prime award create an unfunded liability for the University. The University (and ultimately the PI and Department) would be responsible for covering the expenses that are outside of the prime award and not covered by the prime award. Therefore, the Subcontracts Team is not in the position to commit the Department and PI to cover such expenses.

An NCE extends the current budget period through the new end date. It does not create an additional budget period. Carryforward requires the addition of a new budget period so that funds may be carried forward from one budget period into another. So, carryforward would not be applicable in this instance because with the NCE we are allowing the subrecipient to continue spending the funds already allocated. If we need to create a new budget period, then the transaction would not be an NCE but an additional budget period with carryforward. The “Other” field in the Amendment Request section can be utilized to explain the request.

No, PeopleSoft is the system of record. If the NOA is not in PeopleSoft yet, then the award has not been fully setup. Most awards allow us to spend back to the start date and we can allow our subrecipients to do the same. Therefore, we wait till the NOA to be setup in PeopleSoft before issuing the subawards. Otherwise, this creates an unfunded liability for the Department and PI. Moreover, for new subawards, we need the A# and Project ID setup before we can setup the SC# and we need the SC# for the subaward.

No, another request form is not needed. Please work with whomever is processing the transaction to update the budget amount instead of emailing the central Subcontracts Team email box. Also provide the PI’s approval of the new budget amount in lieu of submitting another request form.

A budget justification is required for all new cost-reimbursable subawards and amendments that add budget items that were not previously described in a budget justification. The budget justification is part of the subrecipient monitoring required under the Uniform Guidance (2 CFR 200.332(d)). We as the pass-through entity are required to monitor the activities of the subrecipient as necessary to ensure that the subaward is used for authorized purposes, in compliance with Federal statutes, regulations, and the terms and conditions of the subaward.

We review the budget and justification to ensure they conform to the regulations and policies of the sponsor and to meet our obligations of monitoring the subrecipient under the Uniform Guidance (2 CFR 200.332(d)). We will give a quick review of the calculations to ensure the budget adds up to the total amount being provided. This ensures there are no legal inconsistencies and reduces the need to issue amendments correctly errors later on.

A completed form is required for each transaction. The form collects the necessary information for putting together the transaction as well as the contact information for where to send it. In addition, the form collects the PI’s signature and therefore approval of the transaction.

The PI is responsible for the overall management of their award including the subawards. When the PI signs the SRF, they are approving the scope of work, budget, budget justification, and the compliance pieces required for managing the subaward. The Subcontracts Team can only process the transactions as has been requested. We cannot assume what was intended. For instance, if the PI wanted to restrict carryforward but the form said it was automatic, then the Subcontracts Team will need PI concurrence that the carryforward should be restricted. Processing the transaction incorrectly may lead to a financial liability for the University. The SRF may either be corrected and resigned, or an email with PI concurrence to the corrections is allowable.

• Yes, a change in budget amount requires PI approval regardless if the change is an increase or decrease.
• Yes, a change in project dates requires PI approval.
• Yes, if the incorrect box was marked for an amendment, the PI does need to reapprove because they approved a different transaction and we cannot assume what was intended.

It depends. For federal flow through, the budget period is capped at one year even if we received a multi-year award from the NIH or other Federal agency. This ensures we are monitoring the subrecipient in compliance with the Federal regulations and agency specific requirements. For non-Federal flow through, check the prime terms and conditions. We may be able to issue the subaward for the full period of performance.

The Scope of Work (SOW) needs to describe the work that is to be performed by the subrecipient. It should contain sufficient detail so that there is no ambiguity about the activities to be performed and the deliverables required from the subrecipient. The deliverables would include any technical/scientific reports required. If the SOW contains information related to the agreement like dates, PI names, budget amounts, etc., please review to ensure they have been updated and align with the request. Inconsistent dates, amounts, etc., create legal inconsistencies in the subaward contract and can lead to issues later.

A SOW is required for all new subawards. For fixed rate/fixed amount subawards, the SOW may be included on the milestone and payment schedule as one document instead of two.

Yes, but we do not need a revised or updated SOW. The language in our subaward amendments updates the end date throughout the subaward contract. A revised SOW including the new end date is not required but may be provided.

It depends on the purpose of the decrease. If the decrease is a general decrease and there is no changes to the scope of work a revised budget is not needed. If the decrease is needed to remove specific tasks or budget line items, a revised budget/scope of work is needed. The revised documents can then be incorporated into the subaward agreement.

Often yes but it depends on for what the funds will be used. If the additional funds are being provided to cover more work, then yes, a scope of work (additional or revised) is required. For example, the original SOW stated that the subrecipient would process 100 samples. We now need the site to process an additional 25 samples. The SOW should be updated to reflect that the subrecipient is processing a total of 125 samples. Otherwise, they may not be contractually obligated to process the additional samples. We may have just allowed them to invoice for more funds to process the original 100 samples.

Yes, we need either a revised budget for the new total or an additional budget which details how the funds will be spent. If the project is a fixed rate project and we need to increase the ‘do not exceed amount’, a budget is not required because we already have the fixed rate amount. Please provide a comment in the Comment section detailing what is changing. For example, the total number of patients the subrecipient is allowed to enroll is increasing from 5 patients to 10 patients.

Effective November 12, 2020, the Uniform Guidance was updated. Every five years the regulations are required to be reviewed and updated as needed. These are now required data elements that we need to include in the federal flow through subawards. See 2 CFR 200.332 (a)(1) (v) and (ix).

No, these data elements are only required for federal flow through but may be included for all other subawards.

No, the Subcontracts Team does not have a preferred format for the budget. Although the SF424 budget page is a good example because it breaks the costs down by major category and includes a calculation of the indirect costs with the appicable rate and base.

The PHS 398 budget page does not provide the details needed for issuing a fixed rate agreement. The Subcontracts Team needs more than just the fixed rate amount. A milestone or payment schedule is needed for the fixed rate agreements. The payment/milestone schedule details the amount of each payment, what activities trigger a payment, and/or when that payment will happen. The detail needed for each payment/milestone schedule will be dependent on the project. The description of what triggers a payment should be clear and unambiguous. See Fixed Rate Guidance for more information.

The NIH Notice of Award will affirmatively state if carryforward is automatic or requires prior approval from the GMS/GMO. For all others review the sponsor’s terms and conditions.

The EIN is needed for all domestic subrecipients when the subaward/subcontract contains federal flow through funding.

The Subcontracts Team uses the 9 digit EIN to locate the Single Audit in the Federal Audit Clearinghouse (FAC). As part of our obligations under the Uniform Guidance (2 CFR 200.332(b)), the Subcontracts Team is required to locate the Single Audits for the subrecipients with which we contract. The FAC does not recognize the longer versions used by the NIH or federal agencies. Moreover, searching in the FAC by name can return inaccurate or incomplete results.

The UEI is needed for all subrecipients when the subaward/subcontract contains federal flow through funding.

No, as of April 4, 2022 the Federal Government stopped accepting the DUNS as the unique entity identifier. The UEI created in SAM.gov is the official unique entity identifier.

No, we may not make a subaward to a subrecipient unless that subrecipient has obtained and provided to us a unique entity identifier (2 CFR 25.300). Moreover, we are required to include the UEI in the subaward because it is a required data element under 2 CFR 200.332(a)(1)(ii).

Maintaining an active SAM.gov registration is for entities that receive funding directly from a federal agency. See 2 CFR 25.200. A subrecipient may obtain a UEI from SAM.gov without completing the fully registration process. Although review prime sponsor’s policies because they may require that the subrecipients also maintain an active SAM.gov registration.

The Subcontracts Team collects the IACUC and IRB letters from the foreign subrecipients. This is a compliance check that Subcontracts Team has performed for many years to ensure the subrecipients have the approvals prior to working on vertebrate animals or human subjects research.

No, the Subcontracts Team will accept the letter in a foreign language. If the letter can be translated by Google Translate or another service, please provide that. Otherwise please provide PI concurrence that the IRB or IACUC letter is in fact the appropriate approval.

No, some foreign IRBs and IACUCs do not include an expiration date. However, if the letter does have an expiration date, please make sure that the date is in the future and not about to expire. If it is expired or about to expire, please add a comment that an updated IRB or IACUC letter will be provided once received by the PI.

No. The IRB or IACUC numbers can be found in CACTAS and PeopleSoft. If the Subcontracts Team needs to review, then we can find the information in our systems. Even when the site is relying on the UCSF IRB, the Subcontracts Team does not need a copy of the UCSF IRB.

Unless the sponsor indicates a specific indirect cost rate in their written guidelines/policy, subrecipients on UCSF projects should apply their Federally-negotiated F&A rate, their State-negotiated rate for State of California agencies (e.g., City and County of San Francisco) the de minimis rate of 15%, or elect to not apply indirect costs. UCSF does not negotiate F&A rates with the subrecipient entity.

The F&A rate agreement is needed whenever the subrecipient will use their negotiated rate for calculating the indirect costs. If the sponsor has a different policy like 0% on some non-profit funded projects or 8% for NIH K awards, then the negotiated rate agreement does not need to be provided. We are required to include the applicable rate in the subaward because it is a required data element under 2 CFR 200.332(a)(1)(xiv).

As part of our obligations to monitor the subrecipients under the Uniform Guidance (2 CFR 200.332), we need to review the budget each time to ensure the F&A rate used on the budget is an allowable rate. If the rate changes, we need to include the new rate in the amendment because it is a required data element under 2 CFR 200.332 (a)(1)(xiv).

Yes, we still need a copy to review the budget that has been provided to us. This review becomes a part of the auditable record and we need the back-up documentation each time.

No, we must follow the sponsor’s policy regarding indirect costs. The subrecipient institution may decide to accept less than they are allowed. Moreover, under the Uniform Guidance we are required to honor the negotiated rate agreement of the subrecipient (2 CFR 200.332(a)(4)).

The Dean’s Office for BCH Oakland contains a lot of information regarding the Work Orders. The Department will need to provide a RAS Project ID that is tied to an Oakland location code. This allows the Department to create a Speedtype that can be used by Oakland to direct charge Oakland personnel costs and clinical care costs. Per the Research Services Agreement with BCH Oakland, the Subcontracts Team will process a Work Order, which include a Scope of Work for the Oakland portion, a detailed budget of the Oakland direct costs only, and a copy of the agreement.

The World Bank defines Low and Middle Income Countries are those countries with Gross National Income per capita of less than $13,205. The Wellcome charitable foundation maintains an easily readable list of countries that meet this definition.

The purpose of the advance is to provide enough capital so that the subrecipient has funds on hand to pay for the project. 

The working capital advance is limited to 25% of the annual amount plus upfront costs including the purchase of equipment. 

• Example 1: If the subaward is for 1 year and the total amount for that year is $120,000, then 25% of the annual is $30,000. $120,000*25% = $30,000
• Example 2: If the subaward is for 6 months and the total amount for that six-month period is $60,000, then 25% of the annual is $30,000. To obtain the annual amount double the total since that would make the project theoretically 12 months. That theoretical total is $120,000 and the monthly amount is $10,000. $120,000*25% = $30,000
• Example 3: The subaward is for 1 year and the total amount is $65,000 with $5,000 being included for the purchase of equipment. The equipment costs are excluded. So the annual amount is $60,000. 25% of $60,000 is $15,000.The working capital advance would then be the $15,000 plus the $5,000 for the equipment for a total of $20,000.

The Office of Clinical Trial Activiation (OCTA) works with investigators and industry sponsors to negotiate the contracts and budgets for all clinical research studies funded by a private, for-profit entity. Contact OCTA to set-up an industry-sponsored clinical trial. 

For clinical trials funded by nonprofit or governmental entities, please contact your OSR staff.

For information and contacts for business contracts, visit the Business Contracts page.

The Institutional Information page includes much of the detail you may need.  For additional guidance, please contact OSR Staff.

The OSR staff member who assisted with your proposal submission will be able to answer questions about an award that is currently in-process or a proposal that was submitted but not yet funded.

Contact OCTA for Clinical Trial proposals submitted through Office of Clinical Trial Activiation (OCTA).

Amendment term changes that do not require substantive negotiation and can be reviewed by Proposal and Grants team:

• Timeline Changes such as financial reporting periods period of performance, budget periods, no-cost extension
• Funding increases/decreases
• Administrative changes in the status of PI/Key Personnel/Department, contact information, carryforward, rebudgeting, placing/lifting restrictions, early termination

Amendment term changes that require substantive negotiations for alignment with UC policy and should be reviewed by the Awards team:

• Publication, publicity
• Intellectual property, patents, licenses, copyright
• Rights to research results and use of data and materials
• Confidentiality Insurance, liability, indemnity
• Governing law, dispute resolution

View the HRRP webstie for IRB submissions and modifications. Contact IRB staff for assistance. 

View the IACUC website for protocol submission and their FAQ regarding submitting a modification. Contact IACUC staff for assistance. 

Contact your OSR staff if you have further questions regarding  the steps necessary to make an administrative modification.

A majority of the help hover texts were updated to assist department requesters in completing the Professional Services Agreement (PSA) request form. Clinical services provided by UCSF campus faculty/personnel to another entity are documented in a PSA. The most significant updates can be found in the Billing Section. There are new fields requesting the sources used to support compensation rates and the ability to upload documents to justify rates as fair market value (FMV).

Instructional Video on submitting a PSA Request 

The Billing Section was updated based on findings from an internal UCSF audit that as a campus, UCSF can do better in complying with federal rules and regulations, such as the Anti-Kickback Statutes and Stark Laws, regarding the provision of clinical services to another entity. FMV is a key component for compliance with these rules and regulations. The new Billing Section was designed in collaboration with the School of Medicine’s Dean’s Office, UCSF Office of Healthcare Compliance & Privacy, and UCOP Legal. This new section was built with various help texts, flags, fields with a selection of FMV sources and other mechanisms to assist departments in thinking about FMV; thus, moving the whole UCSF community toward compliance.

Yes, you can submit a request without uploading supporting documents. However, the request may be declined by the Vice Dean for Clinical Affairs from the School of Medicine. This office provides a quick review of all PSA requests. If the Vice Dean approves the request, it is routed to the Business Contracts Unit (BC). A Contract Specialist in BC will further review the request to ensure a PSA is appropriate for the activity and follow up with department requesters on any missing information and documentation.

BC supports outgoing campus clinical services. BC acts as a conduit with other UCSF offices such as Risk Management, Privacy and Legal, along with other campus stakeholders when necessary to ensure the agreements meet UCSF policies and procedures.

FMV means the value in arm’s-length transactions, consistent with the compensation that would be included in a service agreement, as the result of bona fide bargaining between well-informed parties to the agreement who are not otherwise in a position to generate business for the other party at the time of the service agreement. Questions about FMV for a particular agreement can be discussed further with the subject matter expert at UCOP Legal.

Sources for documenting FMV include, but are not limited to, independent evaluation firms, MGMA Salary Survey, Sullivan Cotter Survey, other party fee schedule, etc. The new Billing Section provides a list of sources that may be used.  Although FMV is required for legal compliance, it is ultimately a business practice question.

Yes, old reports generated before Lightning are still available in Lighting.  

Salesforce is the overall system housing the CACTAS platform and the TAA/PSA platform.  At UCSF, Salesforce and CACTAS are used interchangeably. UCSF was operating on an old version of Salesforce (Classic). The more current version of Salesforce (Lightning) will allow us to utilize the system to its fullest.

Aside from a different look, the TAA Request Page has minimal changes. 

Instructional Video on submitting a TAA Request

YES! The Clone feature works in Lightning. 

The Global Search feature will provide results for Service Agreement (SA) records and requests, files, and folders. Use the search bar up at the top of the page to refine your search criteria by: Department or Name of Other Party (PSA); School or Name of Affiliate (TAA). The columns in the results page can be used to sort records by Agreement and Amendment End Dates.

If known, a specific department can be typed into the search bar at top of the page. This will yield the best results.

If unknown, try doing a broad search ex: the Department of Pediatrics uses the abbreviation “PEDS” before any specialty/sub-department. Keep in mind that typing in “M_Orthopaedic Surgery” vs. “Orthopaedic Surgery” may yield different results.

Instruction Video on the Global Search Feature for PSAs

Search for specific Schools by spelling out the school: “Nursing”, “Medicine”, “Dentistry”, or “Pharmacy”; or use the school acronym: “SON”, “SOM”, “SOD”, or “SOP”.

Instruction Video on the Global Search Feature for TAAs

Instruction Video on PSA reporting

Available Report: PSA For Department with Amendment and agreement end dates.  Open the PSA report. Select “Edit” in the top right-hand corner to go to the report customization page. On the left-hand column, switch over to the “Filters” tab. Select the “Department” field, then set the operator to “contains” if you’re doing a broad search, or “equal” if you know how the department is coded in CACTAS. Type in the Department parameters and apply your changes. Select “Run” in the top right-hand corner to see the full list of records. Click on the “Agreement End Date” and “Amendment End Date” columns to sort the results chronologically.

 Instruction Video on TAA reporting

Available Report: TAA For Schools with Amendment and agreement end dates. Open the TAA report.  Select “Edit” in the top right-hand corner to go to the report customization page. On the left-hand column, switch over to the “Filters” tab. Select the “School” field, type in the School you’re searching for and apply your changes. Select “Run” in the top right-hand corner to see the full list of records. Click on the “Agreement End Date” and “Amendment End Date” columns to sort the results chronologically.