Research Affairs / 
Forms & Online Tools


INDEX TO FORMS:

Animal Welfare Protections (Applying to LLU's IACUC)
Authorship Guidelines

Clinical Trial Center Forms (see comprehensive list on CTC website)
Research Price Lists for Clinical Research

ClinicalTrials.gov Registration

Contracts Guide
Clinical Trial Agreements (coordinated by the Clinical Trial Center)
Sponsored Research Agreements
Subcontracts
Transferring Research Materials (Material Transfer Agreements)
See also Technology Management-related agreements 

Effort Reporting

Grants Guide - Pre-Award
Find Funding
Pre-Award Financial Management (Budget development, F&A costs, Cost Sharing, etc)
Proposal Development
Cover Sheet Information
LLU Transmittal

Grants Guide - Post-Award
Post-Award Financial Management

Human Research Protections (Applying to LLU's IRB)

HIPAA (Privacy in Research)

Research Conflict of Interest

Technology Management
Disclosing an Invention
Protecting an Invention (Confidential Disclosure Agreements)
Licensing an Invention


Animal Welfare Protections

Applying to LLU’s Institutional Animal Care and Use Committee (IACUC)

 

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IACUC-IBC-RSC Application Form 1/10 (doc)

Use this application to submit a protocol for animal research to the LLU Institutional Animal Care and Use Committee (IACUC).  Also included are application questions for the Institutional Biosafety Committee (IBC) if you are using biohazardous materials and questions for the Radiation Safety Committee (RSC) if you are using radioactive materials

Authorship Guidelines

Authorship Guidelines


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Authorship criteria administrative guidelines.

Clinical Trial Center

Research Price Lists

 

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In order to facilitate clinical trial processing and to have consistent research pricing at our institution, the Clinical Trial Center has established four standardized Research Price Lists for our clinical research community. 

ClinicalTrials.gov Registration

ClinicalTrials.gov Registration Worksheet

 

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ClinicalTrials.gov Registration Worksheet 10/10 (pdf)

Use this worksheet to help determine whether your clinical trial must be registered with ClinicialTrials.gov. 

Helpful Links & Tools for ClinicalTrials.gov Registration

Contracts Guide

Transferring Research Data and Materials

Material Transfer Agreements

 

 

 

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Materials Transfer Agreements (MTAs)  are used for incoming and outgoing materials of Loma Linda University to other research institutions, commercial companies, etc.  MTAs describe the terms under which LLU researchers and outside researchers can share materials, typically for research or evaluation purposes. Intellectual property rights can be endangered if materials are used without a proper MTA.

Helpful Links & Tools for Material Transfer Agreements

Sponsored Research Agreements 

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Sponosored Research Agreements describe the terms under which sponsors provide research and/or funding support to LLU.

Contract Request Form (pdf) 

If you determine that a contract is the appropriate instrument to secure services, then this form must be completed and forwarded to the Contracts Analyst.

Helpful Links & Tools for Subcontracts

Subcontracts








 

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Subcontract Request Form (pdf)

If you determine that a subcontract is the appropriate instrument to secure services, then this form must be completed and forwarded to the Contracts Analyst  

Subrecipient Commitment Form 4/11 (pdf)

All subrecipients must complete this form when submitting a proposal to Loma Linda University. It provides a checklist of documents and certifications required by sponsors, as well as an area for the authorized institutional representative to sign. The completed form should be submitted to LLU Research Affairs 5 working days before the sponsor deadline.

Helpful Links & Tools for Subcontracts

Effort Reporting

Personnel Activity Reports (PARs)

 

 

 

 

Affiliate Invoices & Effort Certification

 

 

 

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Personnel Activity Reports (PAR) (xls)

This form, generated by University Payroll, lists the total activity for which the employee is compensated.  Total activity is listed with the account numbers the employee is paid from in conjunction with the level of effort being paid from the different accounts or sponsored projects.  The employee must evaluate the effort and accounts and determine is it is accurate or if changes need to be made according to what they actually spend their time (effort) on. 

Affiliated Invoices & Effort Certification (xls)

This document is used to certify effort for NON-University employees.  Effort reporting systems have not been set up with the various Loma Linda affiliates such as Faculty Physicians and Surgeons, Loma Linda University Health Care, LLUMC, etc.  Therefore, Affiliate Invoices & Effort Certification documents serve two purposes:  1) to certify employee effort, and 2) to reimburse the affiliated entity for the time the employee spends working on the project.

Helpful Links & Tools for Effort Reporting

Grants Guide -- Pre-Award

Find Funding

 

 

 

 

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Instructions for Conducting SPIN and SMARTS Searches in LLeRA (pdf)

This document provides step by step guidance on how to search for funding using LLeRA.  The LLeRA database includes funding opportunities from federal agencies, foundations, professional societies, associations, and corporations. 

 2 types of searches are described:  SPIN (for immediate queries) and SMARTS (a saved query that can be sent on a daily basis). 

Financial Management

Budget Development

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Facilities & Administrative Cost Waiver Form

 

 

 

Cost Sharing

 


 



Request for Pre-Award Spending

 

 

 

Links to OMB Circulars

 

 

 

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Budget Planning Rate Guide (pdf)

This document summarizes important information to consider when drafting a budget for a sponsored research project, such as current F&A rates, fringe benefit rates, salary caps, tuition and health insurance rates for students and post-docs, etc.

Budget Templates:

Detailed Budget -- This budget example breaks down the estimated project costs in detail. A detailed budget template is available for federal projects to help determine the costs of a project. For non-federal projects, a separate template is available.

NIH Modular Budget – NIH does not require a detailed budget to be submitted if the project allows for modular budgeting. However, the institution does require detail for personnel and costs that are exempt from F&A. This budget lists personnel costs in detail (required by the institution) and summarizes the remaining costs.

An NIH Modular Budget template is available to help determine how many modules should be requested. Please note that subcontract direct and indirect costs are both charged as direct costs. However, the subcontract F&A costs may be requested above the normal $250,000 direct cost limit. NIH forms provide fields to separately capture consortium F&A costs for each budget year.Note, consortium/contractual F&A costs are not factored into the direct cost limit. They may be requested in addition to the $250,000 limit.

Clinical Trial Cost Budget – The clinical trial budget template is very detailed.

Budget Justification example    

Proposal Budget Review Guide (pdf)

This document identifies the information and documents that will be required in order for Research Affairs - Financial Management (RAFM) to review and approve a proposal budget.

Helpful Links & Tools for Budget Development

 

F&A Waiver or Reduction Form (pdf)

Use this form to request that the F&A rate on a sponsored research project be waived or reduced. 

Helpful Links & Tools for F&A Costs

 

Cost Sharing Authorization Form (pdf)   

Use this form to get authorization to include cost sharing as part of a sponsored research budget.

Helpful Links & Tools for Cost Sharing

 

Request for Pre-Award Spending (pdf)

Use this form to open an account for spending award funds before the official award notice has been received. 

Helpful Links & Tools for Pre-Award Spending

 

Proposal Development 

 

 

 

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LLeRA Proposal Development Instructions (pdf 12/10) 

For the majority of submissions to federal sponsors via the Grants.gov portal, Loma Linda University uses the LLeRA (Loma Linda electronic Research Administration) system-to-system (S2S) software. (Request LLeRA password)

Helpful Links & Tools for Proposal Development

Cover Sheet Information

 

 

 

 

 

 

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SF424 Cover Sheet information

This web page summarizes the information commonly required on the NIH SF424 cover sheet (applicant information, employer identification number, organizational DUNS number, etc.) and other commonly required information on proposal applications.

A more detailed version is available for LLU investigators (must be logged into MyLLU).

Generic Proposal Cover Form 12/10 (doc)

This form is required for use by LLU investigators as a cover form for those extramural funding agencies not providing their own proposal cover form and includes essential administrative information required by most sponsors. 

LLU Transmittal

 

 

 

 

 

 

 

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LLU Transmittal Form RA 2/13 (pdf)

When you plan to submit a sponsored research application or need assistance in starting a new record, you start with the LLU Transmittal.  Fill in all the required sections on the first page, then submit to Research Administration either by hard copy, fax, or by clicking on the "Submit by Email" button to email the form as an attachment (option available for those who have Adobe Professional installed on the computer).

Always use the current version of the LLU Transmittal from the website instead of using one stored on a hard drive.  

Helpful Links & Tools for the LLU Transmittal

Grants Guide -- Post-Award

Financial Management

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Commonly used account codes (xls)

This lists the most commonly used account codes for grant and contract accounting.  The full chart of account codes can be found by logging on to http://myllu.llu.edu/ under Business/Finance, choose Forms & Docs, and then click on the Documentation folder. 

Contractor vs Employee Status form 6.04.09 (pdf)

This form may be required by Human Resource Management when hiring a Consultant.

Equipment Release Authorization Form (pdf)

Before transferring, selling, re-assigning, or disposing of equipment bought with sponsored funds, you must submit this form, along a written request describing the intended action, to Sponsored Projects Financial Management.

Payment Voucher (xls)  Use this form for:

  • Invoices when a purchase order is not applicable
  • Consultant/independent contractors for services up to $5,000 (also attach Contractor vs. Employee Status form)
  • Utilities, dues, memberships, subscriptions, postage, delivery charges, and other relatively small miscellaneous expenditures

Personnel Activity Reports (PARs) see Effort Reporting

Procurement Analysis Form

All sections must be completed for each equipment purchase in excess of $2,500. Check all that apply.

Request for Sponsored Project Access (xls)  Use this form to add, modify, or delete users for: 

  • signature authority on sponsored project accounts
  • Banner access, or
  • Animal Care Purchases
This form is required to transfer an expense from one account to another that has been posted over 90 days.

Human Research Protections

Applying to LLU's IRB

Determination Request

Checklists for Review

 

 

 

 

 

 

 

 IRB Application

 

 

 

 Abstract Templates

 

 


Preparing the Informed Consent Document

 

 

 

 

 

 

 Protocol Outlines

 

Radiation Safety Application

Recruitment Forms

Reporting an Emergency Use of an Investigational Device or Drug

LLU Federal Wide Assurance with OHRP 

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    Note that Expedited does not mean a "fast" or shorter review. It refers to federally-defined categories of minimal risk research (45 CFR 46.110, 21 CFR 56.110)

    Both exempt and expedited research must meet all ethical and institutional regulations.  This may be reviewed administratively, rather than by the Full Board.

 

 

 

 

 

 

 

 

Privacy in Research (HIPAA)

Applying to LLU’s Privacy Board 

 

 

 

HIPAA Guidance for LLU Researchers  

 

 

HIPAA Definitions 

 


Other HIPAA Forms

 

 

 

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Research Conflict of Interest

Research Conflict of Interest Disclosure Form 

 

 

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electronic Research Conflict of Interest Disclosure form 

Helpful Links & Tools for Research Conflict of Interest

Technology Management

Disclosing an Invention

 

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LLU Invention Disclosure Form

Helpful Links & Tools for Invention Disclosure

Protecting an Invention 

Confidential Disclosure Agreements

 

 

 

 

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Confidential Disclosure Agreements (CDA) protect the confidentiality of an invention as it is being evaluated by potential licensees. CDAs also protect proprietary information of third parties that LLU researchers need to review in order to conduct research or evaluate research opportunities. Research Affairs - Financial Management manages CDAs that are related to non-clinical research contracts.

Helpful Links & Tools for Confidential Disclosure Agreements

Licensing an Invention

License Agreements

 

 

 

 

 

 

 

 

 

 

Inter-Institutional Agreements 

 

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License Agreements describe the rights and responsibilities of a party related to the use and exploitation of intellectual property developed at Loma Linda University. LLU license agreements usually stipulate that the licensee should diligently seek to bring the intellectual property into commercial use for the public good and provide a reasonable return to the institution.

License Option Agreements (or option clauses within research agreements) describe the conditions under which Loma Linda University preserves the opportunity for a third party to negotiate a license for intellectual property. Option clauses are often provided in a Sponsored Research Agreement to corporate research sponsors or are entered into with third parties wishing to evaluate the technology prior to entering into a full license agreement.

Helpful Links & Tools for Licensing an Invention

Inter-Institutional Agreements describe the terms under which two or more institutions (e.g., between two universities) will collaborate to assess, protect, market, license and share in the revenues received from licensing jointly owned intellectual property. 

Helpful Links & Tools for Inter-Institutional Agreements