Extramural Checklist Instructions & Glossary

Extramural Checklist Instructions & Glossary

Office of Sponsored Programs Guidance Extramural Checklist Instructions & Glossary

Extramural Checklist Instructions & Glossary

Download UAB Extramural Checklist (fillable PDF form) here.

Sponsor Portal - If you are submitting your application through a sponsor portal, indicate which one (e.g., ASSIST, FastLane, Workspace, etc.). Otherwise select N/A.

Sponsor Portal Application # - If you are submitting through a sponsor portal, indicate the application number given by the sponsor in the portal.

OSP Review – Indicate the type of OSP review requested. Options are Complete or Limited Review. See OSP Review Plan for more information.

1.     PD/PI - Indicate last name, first name, middle initial, BlazerID, telephone number, email address, and mailing address of the Principal Investigator (PI). This policy defines who may serve as a Principal Investigator.

Submitting Unit – Indicate the UAB School, Department, and Division (if applicable) to be associated with this project. The submitting unit should be the primary appointment of the Principal Investigator (PI). Centers are not valid entries. 

Graduate Student Fellowship - If this application is to support a Graduate Student Fellowship, select Yes.


VA-IPA Assignee – If this application is to support a Veteran’s Affairs-Intergovernmental Personnel Act (VA-IPA) assignee, select Yes.

 

Trainee/Assignee - Enter the fellowship trainee or VA-IPA assignee name, BlazerID, phone, and email address.

2.     Funding Source/Sponsor: Enter the sponsor from whom UAB will directly receive funding. If not applicable, select N/A.

Note: If a clinical research organization (CRO) is involved, indicate the CRO in #23 and not here.

  1. CFDA # – Enter the Catalog of Federal Domestic Assistance (CFDA) number. The CFDA number is a unique number that indicates the particular Federal agency and program. It is usually found on the notice of grant award or may be in the program announcement.  If not applicable, select N/A.

    Note: CFDA# does not apply to federal contracts or industry agreements.

    Single IRB - Please refer to the web page for 
    Single IRB for more information. If Single IRB is applicable to your submission, select Yes. Otherwise, select No.
  2. Submission Type - Select the Submission Type for project being submitted. Some submission types may require additional information such as an existing OSP assigned number, start/effective date, and sponsor award number.

See definitions in table below.

Type

Description

Original/New

Application to fund a new project not currently funded by this sponsor.

Fee for Service

Certain Research Related Fee for Service agreements are processed by the Office of Sponsored Programs. Under these agreements, UAB receives funds from an external entity to perform research related work in facilities owned or leased by UAB. Please see the corresponding announcement and memo regarding Fee for Service agreements.

Transfer In

Application to relocate a currently funded project from another organization to UAB.

Study Startup Agreement

Definition TBD. Agreement to fund study expenses incurred prior to site initiation.

Note: Not all sponsors require a study startup agreement. These expenses are generally included in the project budget.

Resubmission

Revised application to the same sponsor, replacing an earlier application that was not funded. Provide the previous OSP Assigned Number

Competing Continuation/Renewal

Competitive application to secure continued support from the same sponsor for a currently funded research program (subject to peer review), or an application to the state and local sponsor for an additional term of support based on a currently funded project. If this is a Competing Continuation, provide the original OSP Assigned Number and original project start date.

Change in PI

Request to replace the current Principal Investigator (PI) or Project Director (PD). Provide the current OSP Assigned Number, the previous PI's name, and the effective date of change.

Amendment/Modification

Amending one or more provisions of an existing agreement to increase or decrease funding. Provide the OSP Assigned Number and Sponsor Award Number.

Supplement/Revision

Application for additional funds for a currently funded project, i.e., Minority Supplement, Research Experiences for Undergraduates. Provide the OSP Assigned Number and Sponsor Award Number.

Transfer Out

Relinquishing a currently funded project from UAB to another organization. Provide the OSP Assigned Number and Sponsor Award Number.

5.     Sponsor Deadline Date - Enter the sponsor deadline date. If not applicable, select N/A.

Note: Do not include a deadline date for industry contracts. Also, remember that the sponsor deadline date refers to the sponsor deadline only and not your personal or departmental deadline.

  1. On Campus/Off Campus - Indicate where the project will be conducted. Off campus refers to activities performed in facilities not owned or leased by UAB.

    Note: If more than 50% of a project is performed off campus (excluding the subcontract component), the off-campus rate will apply to the entire project.

7.     Performance Sites - Check the appropriate boxes for all performance sites to be used. If an off-campus or other location is used, please indicate the location in the appropriate field.

  1. Cost Sharing - Indicate if cost sharing will be used in this project. If Yes, indicate the type of cost sharing that will be used. See the Cost Sharing Commitment Form or In-Kind Cost Sharing Form for definitions. Cost Sharing definitions are on page 2 of the Cost Sharing Commitment Form. 
  2. Project Title - Enter the full title of the project with no abbreviations. For industry clinical trial agreements (CTAs), this should match the protocol title.

    Note: If there are any changes in title, please contact the Office of Sponsored Programs (OSP).

10.  Award Manager - Enter the last name, first name, middle initial, BlazerID, phone number, and email address of the person managing the funds. 
Primary Contact - Enter the first name, last name, middle initial, BlazerID, phone number, and email of the person to be contacted if a question arises about this application.
Secondary Contact - Enter the first name, last name, middle initial, BlazerID, phone number, and email of the person to be contacted if the primary contact is not available. Leave blank if there is no secondary contact.

  1. Renovation - Indicate if this project involves any renovation. If Yes, Facilities Planning (4-1219) must sign off on this checklist.

    Note: If the primary purpose of the project is construction (e.g., federal or non-federal funding to support construction of building or major renovation), use the Construction Checklist. Construction grants and contracts are considered “Other Sponsored Activities.”

12.  International involvement – If there is no international involvement, select N/A. If there is international involvement, indicate if there is an International Sponsor, International Subcontractor, and/or Activities in any foreign countries. Then, list all foreign countries who are sponsoring the project, all foreign subcontractors, and all foreign countries where activities are taking place.

  1. Keywords - List a minimum of three scientific keywords that best describe your research or project. This will be put into IRAP for reporting purposes. While this is not a required field for OSP, your department/division may require this for reporting purposes.

    Note: Do not list Principal Investigator (PI) name or Sponsor name as keywords

  2. Grants Accounting Financial Management Affiliation – Indicate the UAB department and division responsible for monitoring and managing the award funds and their Organizational Code. If there is no Division for your area, choose N/A.
  3. Billing/Collection Responsibility Designation - Indicate who is responsible for billing/collection by selecting either the Department or Grants and Contracts Accounting (GCA). Include the address to receive payment. If billing/collecting does not apply to the project, select N/A.

    Note: Generally the department is responsible for billing/collection for non-federal clinical trials and milestone-based contracts. Generally GCA is responsible for billing/collection for letter of credit (LOC), Federal, Federal pass-through projects, reimbursement projects, and scheduled payment projects.

16.  Will funds be leaving UAB? Indicate Yes or No. If Yes, indicate whether the funding is for a Subaward/Subcontract, Consultant, or both if applicable. If there are subawards or subcontracts, please indicate how many. If you have subawards/subcontracts, please see our subaward page for guidance. If you have a consultant, please include a letter of support for the consultant as part of the application submission.

  1. Announcement ID No. – Indicate the Announcement or Solicitation number [Program Announcement (PA), Request for Application (RFA), Request for Proposal (RFP), etc.]  to which the proposal is being submitted. If not applicable, select N/A.
  2. Program – Indicate the specific program name to which the proposal is being submitted. Enter the URL address if applicable. If this is not applicable, select N/A. This is needed for many programs that do not have a particular RFP#, PA#, etc. Some non-profits and other federal projects would fit into this category. Include this information so those involved in reviewing your project can find the appropriate solicitation/website.
  3. Purpose (Program Type) - Indicate the purpose for the grant or contract as Sponsored Research, Sponsored Instruction, or Other Sponsored Activities. See definitions below.
    Sponsored Research is all research and development activities that are sponsored by federal and non-federal agencies and organizations. Fellowship/training awards to perform research activities are considered Sponsored Research. Clinical trials are not typically considered sponsored research except when a clinical trial is federally funded.

    Examples of Sponsored Research awards are:
  • Exploring a hypothesis
  • Conducting animal models
  • Fellowship/training awards given for research purposes - federal and non-federal
  • Special purpose equipment - equipment which is used only for research, medical, scientific, or other technical activities.

Included in this category are NIH funding mechanisms starting with the following letters: 

    • F-series
    • K-series
    • N-series
    • P-series
    • R-series (with the exception of conference grants R13 and R25)
    • S-series
    • T-series
    • U-series (with the exception of conference grants U13)

Sponsored Instruction applies when the award's primary objective is to teach and/or train, whether the teaching and/or training is offered for a credit toward a degree or certificate or on a non-credit basis. Such teaching and/or training can be offered through regular academic departments or separate divisions. 
Included in this category are federal grants starting with R25 (education projects). 

Other Sponsored Activities are programs and projects financed by Federal and Non-Federal agencies and organizations that involve the performance of work other than instruction and sponsored research. All non-federal Clinical Trials are considered Other Sponsored Activities including Investigator-Initiated Clinical Trials. 

Examples of Other Sponsored Activities are: 

    • Health service projects and community services programs
    • Conference Grants (e.g., NIH R13 and U13)
    • Theater performances
    • General purpose equipment - equipment which is not limited to research, medical, scientific or other technical activities
    • Construction contracts and grants
    • Verifying and or testing a product that has already been created
    • Travel grants
    • Any awards that are not considered Sponsored Research or Sponsored Instruction

Included in this category are federal grants starting with the following letters or numbers: 

    • G20 (Grants for repair & renovation of existing research facilities)
    • H-series (excluding HHSN which is sponsored research)
    • R13 (conference grant)
    • U13 (conference grant)

20.  Instrument Type: Choose either contract or grant. See definitions below.

  • grant is a funding mechanism for a broad programmatic objective with standard and acceptable terms and conditions which are preset by the awarding entity and are non-negotiable by UAB.
  • contract is a funding mechanism for specific deliverables in which all or some of the more rigorous terms and conditions are subject to review and acceptance by UAB signature, and if those terms and conditions are not acceptable, would require negotiation between the parties.

  Note: Contracts, like those provided by the Federal Government or industry sponsors, are subject to negotiated terms and conditions. 

21.  Activity Description: Choose the type of grant or contract you are submitting. See definitions in the tables below. 

Grant Type

Description

Individual Grant

Grants are awarded to institutions to allow a Principal Investigator to pursue a scientific focus or objective in his or her area of interest and competence. Institutional acceptance assures the Sponsor that the institution will provide facilities necessary to conduct the research and will be accountable for the grant funds. Applications are accepted for research and development in all areas within the scope of the Sponsor’s mission.

For individual grants that are also clinical trials, a Clinical Trial grant provides support for the initial development of a clinical trial, including the establishment of the research team, identifying tools for data management and oversight of the research. It also includes the development of a trial design and other essential elements of the study, such as the protocol, recruitment strategies, and procedure manuals and to collect feasibility data.

Program/Center Grant

To support multidisciplinary or multifaceted research programs that have a focused theme or a specific major objective. Each component project should be directly related to and contribute to the common or specific major objective. (P01, P20, P30, P50)

Individual Training Grant

Individual training grants are awarded to individual fellows to support research training, to broaden their scientific background, with the potential to become independent investigators.

Institutional Training Grant

Institutional training grants are awarded to institutions to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers in areas of biomedical, behavioral, and clinical research. It provides funding to the institution to increase the number of pre-doctoral and postdoctoral trainees who wish to pursue a long term or short term career in research.

Cooperative Agreement Grant

A support mechanism used when there will be substantial scientific or programmatic involvement by the sponsor. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Equipment Grant

An institutional award to support the purchase of equipment to be used by one or more recipients of active research grants.

Educational Activity

An agreement between the institution and the sponsor which provides funds for educational activities through seminars, conferences, workshops and classes that serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships of healthcare personnel. May be accredited or non-accredited.



Contract Type

Description

Individual Contract

A written agreement between the institution and the sponsor which obligates both parties.

For individual contracts that are clinical trials, a clinical trial contract is a study which involves the systemic investigation in a human population of the effects of an experimental drug, treatment regimen, or device for disease or disorder according to a formal protocol. Clinical Trials may be based on industry or investigator written protocols.

Small Business Technology Transfer (STTR)

A federal program designed to support cooperative research/research & development with potential for commercialization, through a formal cooperative effort between a small business and UAB.

Non-Sponsor Funded Research

Entity is providing either a product, material or equipment in lieu of funds.

Small Business Innovation Research (SBIR)

A federal program designed to support small business concerns conducting innovative research/research & development with potential for commercialization through a formal cooperative effort between a small business and UAB

Cooperative Agreement

A written agreement between multiple parties in which the obligations flow between two or more parties.

Educational Activity

An Agreement between the institution and the sponsor that provides funds for educational activities through seminars, conferences, workshops and classes that serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships of healthcare personnel.

Compassionate Use Agreement

Drugs: 
Expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial. 

Devices: 
Compassionate Use (or Single Patient/Small Group Access) The compassionate use provision allows access for patients who do not meet the requirements for inclusion in the clinical investigation but for whom the treating physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition. This provision is typically approved for individual patients but may be approved to treat a small group.

Research Collaboration

A Research Collaboration agreement means an agreement entered between two or more researchers engaged in a research project about the nature of their working relationship. It specifies about the intent of the parties to share data, research materials and facilities, and to publish research findings.?

  1. CCTS Research Type - Select the UAB Center for Clinical and Translational Science (CTSS) Research Type for your project, or select Not Applicable. See definitions below.
    Clinical Research 
    Patient-oriented research (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which a researcher directly interacts with human subjects or human materials. 
    Translational Research 
    The process of applying insights and discoveries generated during laboratory research and in preclinical studies to the diagnosis, treatment or prevention of human disease. 
    This includes:
    • T1 Research: Moving basic discoveries into candidate health applications.
    • T2 Research: Assessing value of T1 application for health practice leading to evidence-based guidelines.
    • T3 Research: Moving evidence-based guidelines into health practice through delivery, dissemination and diffusion research.
    • T4 Research: Evaluating real world health outcomes of a T1 application in practice.

23.  Complete all information regardless of sponsor type or activity description:

    • Enter the Contract Research Organization (CRO) name or choose N/A
    • Enter the Sponsor/CRO contact name, telephone number, email address, and Sponsor/CRO reference number, or choose N/A.
    • Select the appropriate Source of Protocol/Statement of Work (SOW)/Research Plan, or select N/A. Options are: Sponsor-Provided/Written Protocol, UAB Investigator Initiated, or Non-UAB Investigator Initiated.
    • Indicate if this project is a clinical trial by choosing Yes or No.
    • Indicate if the federally funded Clinical Research Unit (CRU) will be utilized by choosing Yes or No.
    • Enter the Funding Source’s Protocol number.
    • Indicate which clinical trial phase applies to your project or No Phase if not applicable (see table below)
    • Enter the Investigational New Drug (IND) or Investigational Device Exemption (IDE) number, or select N/A if not applicable.

Clinical Trial Phase

Description

Phase I

Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

Phase I / II

Combination of Phases I and II.

Phase II

Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.

Phase II / III

Combination of Phases II and III.

Phase III

Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.

Phase III / IV

Combination of Phases III and IV.

Phase IV

Generally, Post Phase IV research is considered "field research" or "community based research" and is designed to test generalization of the intervention to a larger sample and under typical and variable clinical contexts.

No Phase

Select this if phases are not applicable.


Investigational New Drug (IND) Application information may be found here
Investigational Device Exemption (IDE) Application information may be found here
From each web page, links are provided to further information

24.  Requested Project Period Dates – Enter the overall project start and end dates. For industry projects, if a date is not entered, OSP will enter today’s date (when entered into IRAP) for start date and end date as one year from now. This will be adjusted when the agreement is finalized.

25.  Requested Funding - Enter the Direct Costs and Facilities and Administrative (F&A) Costs (also known as Indirect Costs) and total funds requested. Enter the F&A Rate (%), and indicate the applicable F&A Rate Basis in accordance with UAB's current F&A rate agreement.

Note: Please enter 0.00 if non-sponsor funded.
Note: Remember the dollar amount should reflect the new amount/increase and not include any previously awarded amount.

  • Total Direct Cost (TDC) - F&A calculation methodology with no exclusions. F&A is applied to all direct cost categories.
  • Modified Total Direct Cost (MTDC) - F&A calculation methodology that excludes certain direct cost items. Those items can be found in the rate agreement.
  • Clinical - F&A calculation for clinical trials that meet the requirements for flat 30% rate. See Clinical Trials F&A Rate.
  • Fee for Service - Please see the corresponding announcement and memo regarding Fee for Service agreements and associated F&A information.

Note: Modified Total Direct Cost (MTDC) consists of all salaries and wages, fringe benefits, materials, supplies, services, travel and subgrants and subcontracts up to the first $25,000 of each subgrant or subcontract (regardless of the period covered by the subgrant or subcontract). MTDC shall exclude equipment, capital expenditures, charges for patient care, student tuition remission, rental costs of off-site facilities, scholarships, and fellowships as well as the portion of each subgrant or subcontract in excess of $25,000.

UAB F&A (Indirect Cost) Reimbursement Policy

  1. Indicate if any F&A (indirect costs) are to be shared with a department other than the PI's primary appointment. Select Yes or No. If Yes, complete and attach the Indirect Cost Revenue Redistribution Agreement.
  2. Related Agreements - If this project is related to any other agreements, please provide the related document number(s), including the OSP Assigned Number when required.

Indicate if there is a related:

  • Project Master Agreement (PMA). Provide PMA number.
  • Study Startup Agreement (SSA). Provide SSA number.
  • Confidential Disclosure Agreement (CDA). Provide CDA number.
  • Pre-application. Provide OSP number.
  • Other [examples: Material Transfer Agreement (MTA) or Non-Sponsor Funded Research Project]. Provide applicable document number.
  1. Export Control - Review the Export Control guidelines and decision tree and answer the related question - Yes or No.
  2. Existing Intellectual and/or Tangible Property 
    Indicate if you will be using any intellectual property in the conduct of the proposed project by selecting Yes or No. If Yes, answer the additional questions in #29.
  3. Note: A full and accurate understanding of the intention to use existing intellectual property (i.e., conceived and/or reduced to practice) or tangible property (cell lines, etc.) in the proposed study is essential. Identification of property to be used and ownership rights in such property allows UAB/UABRF’s rights in UAB’s existing property to be protected, ensures that UAB uses property owned by third parties in a manner consistent with existing contractual rights and obligations or identifies circumstances where requests for approval for additional rights and uses should be made, and assists UAB in negotiating contractual terms that are realistic, appropriate to the facts and circumstances of the proposed study and maintain an acceptable risk tolerance.

  4. Intellectual Property Declaration 
    Read the intellectual property/invention(s) certifications and check the one that applies. 

Certifications and Signatures 
Signatures required:

  1. Principal Investigator/Project Director – PI/PD certifications are required; no “per” signature is allowed.
  2. Division Director - only if required by the department
  3. Facility and Planning Signature – required if project involves any renovation. See #11.
  4. Department Chair - required
  5. Dean - required if the project has cost sharing, establishes a new faculty position, requests additional space, or is being transferred in or out of UAB

Note: UAB may designate multiple individuals as Project Director/Principal Investigator (PD/PI). All PD/PIs must sign the checklist. If you are submitting an NIH multi-PI/PI application, it must include a Leadership Plan, and the PD/PIs must have a role type indicated in the NIH eRA Commons system. NIH grants that do not allow multiple PIs will indicate that in the funding announcement.