Standard Operating Procedures (SOP)

UC Irvine’s Center for Statistical Consulting (CSC) and the Institute for Clinical and Translational Science (ICTS) Biostatistics, Epidemiology, Research and Design (BERD) units have a primary mission of assisting UCI investigators and affiliates with conducting research of the highest possible quality. Services include:

Free Drop-in Consultations
Grant Submission Support
Database Creation and Management Advice
Statistical and Study Design Considerations for New Studies
Statistical Analysis Services including Consultation and Conduct
Predictive Modeling Analytics and Machine Learning
Development of Clinical Research Protocols
Manuscript Writing and Revisions
IRB Reviews
Statistical Programming and Methodology
Statistical Software Training
Statistical Methodology Training

BERD/CSC are involved in the data analysis of a wide variety of projects. Priority is given to UCI researchers. Collaborations on projects for external (non-UCI) organizations are considered on a case-by-case basis. This document describes the Standard Operating Procedures (SOPs) for statistical analysis services and billing policies. For information about policies and billing administration, contact Margaret Erel, CSC Business Manager and BERD Liaison, at merel@uci.edu.

Policies and Project Requirements

Hourly Rates:

Rates are valid October 1^st – September 30^th. Rates are subject to change on an annual basis. For planning purposes, please factor in an approximate 5% increase each year.

Billable Services:

All project-related activities are billable at the standard hourly rate. This includes, but is not limited to:

Consultation & Coordination: Preparing for and attending meetings, scheduling, and all project correspondence.
Core Methodology: Reviewing source materials, drafting study design or statistical analysis plans, performing data analysis, drafting or editing documents including but not limited to abstracts, manuscripts, and IRB applications, and development of requested workshop materials.
Administrative & Development: Project-specific research and professional development. While some statistical methodology is considered common knowledge or generally applicable in multiple settings, there are times when clients request the implementation of non-standard or unique methodology necessary to address a narrow problem or research scope. In these circumstances we may need to charge for the time needed to learn, understand, and implement those novel methods.

Cancellation and Rescheduling Policy

Please be advised that excessive rescheduling creates administrative overhead and prevents other clients from utilizing the statistician’s available hours. While we allow for occasional adjustments, rescheduling the same appointment more than twice will result in a fee of one billable hour. Standard administrative time for repetitive scheduling changes will also be invoiced at the statistician’s discretion.

Deadlines:

Deadlines should be reasonable and allow sufficient time for review, adjustment of statistical methods as necessary, and follow-up. The best practice is to initiate contact with us at least 6 weeks before any deadline.

Federal Grant Policy:

Per federal regulations, all services must be performed and billed while a grant is active. Please observe the following requirements:

Active Funding: Services cannot be prepaid; work must be completed within the current performance period.
Proactive Scheduling: Researchers are responsible for requesting assistance well in advance of the grant expiration date.
Strategic Planning: Please account for the full scope of the project, including final analysis and reporting, to ensure completion while funds are available.

Complex Data Sets and Data Management:

Large, complex databases often require substantial data management. The additional time needed to create an analyzable dataset can significantly increase project costs. Databases such as All of Us and TriNetX, which rely on proprietary user interfaces, are not designed to support straightforward analysis or data management and have proven challenging to work with. Any complexities or limitations associated with large databases will be discussed in advance so that you are fully informed at the outset of the project.

Free Hour Policy:

All clients receive a free one-hour consultation for every new project. This collaborative planning session is primarily designed to assess project scope, establish timelines, and discuss authorship expectations. Clients seeking general statistical advice should schedule a free BERD drop-in consultation.

BERD Drop-In Consultations:

The ICTS Biostatistics, Epidemiology, Research and Design (BERD) unit offers complimentary 30-minute consultations for clients with general analysis questions. Details:

Availability: Virtual appointments are held Tuesdays from 12:00 PM – 2:00 PM
Requirements: Consultations are free, but ICTS membership is required (membership is free, easy to obtain, and available to everyone). Sign up for ICTS membership when scheduling your appointment.
Scheduling: Schedule your appointment here.
Cancellations: To cancel or reschedule, please email Margaret Erel at merel@uci.edu.

Scope of Work

Scopes of Work (SOWs) are required for all projects except for those by UC Irvine researchers who are paying via subscription model (see Payment Options and Billing Administration). BERD/CSC statisticians will meet with principal investigators (PIs) and research staff about the needs of the project. This initial one-hour meeting is free for all new projects.

BERD/CSC statisticians will draft a Scope of Work (SOW) detailing expectations of the work to be performed, including:

A description of the project
Timeline including deadlines
Deliverables
Estimated hours and cost
Authorship (not accepted in lieu of or in exchange for payment)

SOWs are sent to the client via DocuSign and must be signed within 10 days. Work on the project will not begin until the SOW has been signed by all parties. Staff cannot make an exception for short deadlines.

Deliverables and deadlines set forth in the SOW may be subject to change, depending on data quality, dataset size and complexity, software, changes in methodologies, or other factors. If during the project period the statistician evaluates that the analysis will take longer than the time allotted on the SOW, the PI/researcher will be contacted to discuss the best course of action and a new SOW with updated deadline and/or deliverables will be completed before work resumes.

SOWs for UCI researchers require a financial contact and a valid account number for recharge. If you do not have this information, please check with the Principal Investigator (PI). The financial contact is the person who works with the PI/researcher to manage invoices and payments. A signed SOW without this information will be considered incomplete and work on the project will not begin until the information is provided.

SOWs for external clients (both non-profit and for-profit) must include a financial contact for managing invoices and payments.

External clients, both non-profit and for-profit, must complete a UC Sales and Services Agreement (SSA) in addition to the Scope of Work (SOW).

Sales and Services Agreements

All external clients, including non-profit and for-profit organizations, must complete a UC Sales and Services Agreement (SSA) alongside the Scope of Work (SOW). Work on the project cannot begin until both the SSA and SOW are fully executed.

Types of Assistance

Grant Preparation:

The BERD/CSC units support all UCI investigators and co-investigators by providing essential grant preparation for research studies, governed by the following policies and guidelines.

Grant Preparation Support: Contingent upon the statistician’s inclusion in the proposal. The following funding structures apply:
- Subsidized Support: Provided at no cost if the statistician is allocated a minimum of 5% effort, subject to approval by the PI and BERD/CSC Director.
- Fee-Based Support: If the allocated effort is less than 5%, all services are billed at the standard hourly rate and must be paid as the work is completed.

Budgetary Requirements: Submitted budgets must specify the statistician’s planned duration of effort (years and annual percentage) and include either
- Named Effort: A defined percentage for one or more BERD/CSC statisticians; OR
- Service Allocation: A minimum of 50 hours to be billed at the standard hourly rate.

Clients are required to submit the grant proposal budget before any final deliverables will be provided.

Timeline and Integration: Statisticians require at least 6 weeks prior to the deadline to assist with study development. This involvement includes study design, outcome measurement, sample size calculations, and data analysis plans.
Final Review: The BERD/CSC must review the final application before submission to verify consistency across the design and analysis sections and to confirm that requested statistical funding is sufficient for the proposed scope.

Specialized Research Support:

The BERD/CSC provides statistical expertise for power analyses, IRB applications, data analysis, and the preparation of abstracts, manuscripts, and presentations. These services are governed by the following guidelines:

General Analytics & Submissions: All power analyses and data-driven projects (including manuscripts and presentations) are subject to standard policies regarding timeline, budget review, and billable hours.
Post-Submission Manuscript Revisions: Support for manuscript revisions is determined by your current funding status:
- Active Funding (Grant or Subscription): Revisions are covered under the existing agreement and established percent effort.
- Inactive/Concluded Agreements: If a subscription has ended or the original Scope of Work (SOW) has been fulfilled, a new SOW must be executed to cover the additional time required for revisions or supplemental analyses.

Assistance with Dissertations or Theses:

Graduate students may use BERD/CSC services. However, to establish a formal agreement for data analysis support, BERD/CSC requires direct communication from the student’s primary faculty advisor confirming their awareness and approval of the student’s use of these services for dissertation or thesis work. Please note that BERD/CSC does not help with coursework or qualifying exams.

Data Privacy Policy

The BERD/CSC strictly prohibits the receipt of datasets containing Personally Identifiable Information (PII). It is the sole responsibility of the Principal Investigator (PI) or lead researcher to ensure all data is fully de-identified prior to submission.

Work on the project cannot begin until compliance is verified. Note that “hiding” columns within Excel or other database management tools is insufficient; all PII must be permanently deleted from the file. For comprehensive guidelines on what constitutes PII, please refer to the UCI Information Asset Classification page.

Acknowledgement and Authorship Policy:

Acknowledgement Guidelines

Any proposal, publication, or presentation resulting from the use of BERD/CSC resources must formally acknowledge the center and/or the Institute for Clinical and Translational Science. In cases where a statistician has made significant contributions to the project but does not meet the full criteria for authorship, they should be recognized individually within the acknowledgements section.

Authorship Criteria

In accordance with the International Committee of Medical Journal Editors (ICMJE) standards, BERD/CSC requires that the statisticians be offered authorship if they meet the following four criteria:

Substantial Contributions: Significant involvement in the conception or design of the work, or the acquisition, analysis or interpretation of data.
Intellectual Contributions: Drafting the manuscript or providing critical revisions for important intellectual content.
Final Approval: Review and approval of the final version to be published.
Accountability: Agreement to be accountable for all aspects of the work, ensuring that questions related to the accuracy or integrity of the research are appropriately investigated and resolved.

Protocol and Expectations

Early Consultation: To ensure transparency and avoid misunderstandings, authorship should be discussed at the onset of the collaboration and explicitly outlined in the Scope of Work (SOW).
Right of Refusal: BERD/CSC statisticians reserve the right to decline authorship at their discretion.
Compensation: Authorship is an acknowledgement of intellectual merit and is not accepted as a substitute for financial compensation or service fees.

Project Deadlines and Timeline Management

Lead Times and Scheduling

Early engagement is critical for high quality statistical support. We recommend the following lead times:

Study Design and Protocol Development: Please initiate contact at least 6 weeks prior to your deadline.
Data Analysis: Timelines vary significantly based on complexity, ranging from several hours to several months. Researchers are expected to plan accordingly.
Late Requests: As deadlines approach, our capacity to provide meaningful support diminishes. BERD/CSC reserves the right to decline requests if the remaining timeframe is insufficient to ensure methodological integrity.

Should the statistician determine the analysis requires more time than originally allotted in the SOW, the PI will be contacted to discuss the project’s direction. A revised SOW must be executed before work continues.

Flexibility of Deliverables

Deliverables and deadlines established in the Scope of Work (SOW) are preliminary and may be adjusted based on:

Data quality and dataset size and/or complexity.
Required software transitions or methodological refinements.
Unforeseen analytical challenges.

Mutual Accountability

Successful collaboration requires adherence to agreed-upon schedules.

Adherence to Timelines: PIs are expected to strictly follow deadlines for providing data, protocol drafts, and necessary documentation. Failure to meet these internal milestones will necessitate a timeline renegotiation and updated SOW.
Project Oversight: It remains the PI’s responsibility to ensure the project moves forward according to the required external deadlines. While BERD/CSC endeavors to meet all investigator needs, we cannot accommodate unrealistic timelines the compromise the quality of the work.

Payment Options and Billing Administration

Principal Investigators (PIs) may choose from the following service models:

UC Irvine Researchers:

Hourly Rate Model (departmental recharge): $115 per hour
- Rates are valid October 1^st – September 30^th and are subject to change on an annual basis. Researchers must provide an account number appropriate for the recharge. This internal rate is only available to UCI researchers who are paying via departmental recharge. Statistical analyses paid for by a non-profit or for-profit entity must be billed the external rate, as appropriate. Account Numbers and Financial Contacts: An account number is required for recharge. The listed financial contact is the person who works with the PI/Researcher to manage invoices and payments.

Grant Support Model: Free when the BERD/CSC statistician or unit is included as part of the grant budget.
- To qualify, the inclusion minimum is 5% effort or a minimum of 50 hours. The goal for providing grant support at no cost is to cultivate a collaborative environment that will lead to successful grant applications. For applications that BERD/CSC staff help prepare and write, it is expected that the PI will include them on the grant for a percent effort, as appropriate. BERD/CSC involvement from the initial steps of the application helps ensure that study design, data analysis, and power analysis are appropriate and rigorous, and increases the chance that the grant will be funded.
Subscription Model: UCI Principal Investigators who require statistical support on a variety of projects may “subscribe” to a portion of a BERD/CSC statistician’s time. Those requesting this model must agree to fund a minimum of 5% effort for at least 6 months. This payment model is only available to internal UCI clients. A Memorandum of Understanding (MOU) detailing the length of agreement, account details, and contact information must be signed by all parties before work begins.

External Researchers (Both Non-Profit and For-Profit Organizations):

A UC Sales and Services Agreement (SSA) is required before work on the project may begin. This contract is in addition to the Scope of Work (SOW).

Hourly Rate Model:
- Rates are valid October 1^st – September 30^th and are subject to change on an annual basis.
  - Non-Profit: $152 per hour
  - For-Profit: $178 per hour

Grant Support Model (Sub-Award Required): Free when the BERD/CSC statistician is included on the grant at a minimum of 5% effort. If the percent effort is less than 5%, clients will be billed on an hourly basis. Please note, for this payment model the client must have a sub-award in place for the project.

Payments and Invoicing

All clients who are billed on an hourly basis will receive monthly invoices sent to the email address on file. Payment is expected promptly upon receipt of the invoice, regardless of the completion of specific deliverables.

UCI researchers paying via departmental recharge are responsible for providing a valid account number that is appropriate for the recharge.

External researchers (both non-profit and for-profit) should make payments to “UC Regents” and note the invoice number on the payment.

Prepayments

Prepayment agreements are reserved exclusively for UC Irvine schools and departments in limited circumstances. Please note we do not accept prepayment for services when the funding source is a grant, an external organization (both non-profit and for-profit), or under any other circumstances.

Statistical Financial Support for UC Irvine Researchers

UCI researchers who do not have funds available from extramural grants may seek funding from departmental sources or through Institute for Clinical and Translational Science (ICTS) funding opportunities.

BERD/CSC maintain agreements with the following UCI schools and departments for prepaid services available to qualifying individuals on a limited basis:

School of Biological Sciences:
- Available to faculty, staff, and graduate students.

School of Population and Public Health:
- Available to graduate students only.

School of Nursing:
- Available to faculty only. Graduate students may request services on a faculty member’s behalf but must identify the faculty member as the PI on the service request.

Institute for Clinical and Translational Science (ICTS):
- Available to recipients of T, K, CCRI, ASAP, and Pilot awards, and MSRP.

Best Practices for Investigators: Effectively Engaging with a Statistician

Define Goals Clearly: State the research question, outcomes of interest, and how results will be used.
Engage Early: Involve the statistician during study design or data collection, not just after data are finalized.
Share Complete Context: Provide background, prior analyses, constraints, and relevant domain knowledge.
Provide Clean, Accessible Data: Clarify data sources, formats, variable definitions, and data issues up front.
Remove Personally Identifiable Information (PII): Hiding columns or rows is not sufficient; data must be permanently deleted.
Realistic Timelines: Allow time for data review, method selection, revisions, and follow-up.
Discuss Scope and Assumptions: Agree on deliverables, level of detail, and whit is (and is not) included.
Communicate Constraints: Flag deadlines, budget limits, regulatory requirements, or publication targets early.
Expect Iteration: Plan for questions, refinements, and possible changes as analysis progresses.
Clarify Authorship and Credit: Address expectations for acknowledgement or co-authorship at the outset.
Maintain Open Communication: Respond promptly to questions and schedule check-ins as needed.

Helpful Links

Biostatistics, Epidemiology, Research and Design Unit (BERD)

ICTS membership is required to request services. Membership is free and available to everyone. Follow the prompts at the links below to sign up for membership and request services:

Center for Statistical Consulting (CSC)

Questions? Email us at statconsulting@uci.edu.

Workshops and Training

Visit our UCI Center for Statistical Consulting & BERD Unit page on Eventbrite to view and register for upcoming workshops and training.

Recordings and presentations for our free workshops are available on our website at no charge.