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.

In the heading, check the box if this is an electronic submission (OSP Dropbox), ASSIST#, or Other.

  1. The last name, first name, middle initial, and BlazerID, telephone no. and email address of the Investigator. This policy defines who may serve as a Principal Investigator (PI).

    The UAB School, Department, and Division to be associated with this project. In most cases, this is usually the same as the primary appointment. Centers are not valid entries.

    Enter the trainee or assignee name and BlazerID if this is a fellowship or a VA-IPA submission.

  2. Enter the sponsor from whom UAB will directly receive funding. If a clinical research organization (CRO) is involved, indicate the CRO in #25, not here.

    If this is a pass through, enter the name of the originating sponsor.

  3. Check the Submission Type being submitted:

    Submission Types

    Type Description
    Original/New Application to fund a new project not currently funded by this sponsor.
    Competing Continuation/ Renewal Competitive application to secure continued support from the same sponsor for a funded research program (subject to peer review) or an application to the state & local sponsor for an additional term of support based on a currently funded project.
    Transfer In Application to relocate a currently-funded project from another organization to UAB.
    Amendment/Mod Amending one or more provisions of an existing agreement to increase funding. List the OSP Assigned Number.
    Supplement / Revision Application for additional funds for a currently-funded project, i.e. Minority Supplement, Research Experiences for Undergraduates.
    Change in PI Request to replace the current Principal Investigator or Project Director. Enter the current OSP Assigned Number, the previous PI's name, and the effective date of change.
    Resubmission Revised application to the same sponsor, replacing an earlier application that was not funded. List the previous OSP Assigned Number.
    Transfer Out Relinquishing a currently funded project from UAB to another organization. List the OSP Assigned Number.
    ​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.

  4. If this is a Competing Continuation, enter the original OSP Assigned number and original project start date.

  5. Enter the sponsor deadline date (if applicable).

  6. Check the appropriate box(es) for all performance sites to be used.

  7. 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.
  8. On Campus / Off Campus - Refers to the location of research activities. Off-Campus refers to activities performed in facilities not owned or leased by UAB.

  9. Select the type of cost sharing (if applicable). 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. 

  10. Enter the full title of the project (complete, no abbreviations). For Industry clinical trial agreements (CTA), this should match the protocol title. If there is a change in title, please notify the Office of Sponsored Programs (OSP).

  11. Award Manager: Enter the full name, telephone no., email address, and BlazerID of the person managing the funds.

    Contact Person(s): Enter the full name, telephone no., email address, and BlazerID of the person to be contacted if a question arises about this application. Enter secondary contact information, e.g. study coordinator (FAP), if applicable.

    Secondary Contact: If necessary (optional).

  12. NOTE: If the primary purpose of the project is construction, e.g. federal or non-federal funding to support construction of a building or major renovation, please use the Construction Checklist. Construction grants and contracts should be coded as "Other Sponsored Activities".
  13. Indicate if this project involves any renovation with Yes (Y) or No (N). If Yes, Facilities Planning (4-1219) must sign off on this checklist.

  14. Is the sponsor an international entity? Check if yes.

    Is an international subcontractor involved? Check if yes.

    Will any activities be conducted in a foreign country? Check if yes and enter the name of the country.

    If there are multiple countries, enter the word "multiple" in the space provided.

  15. Select the CTSS Research Type or Not Applicable.

    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.

  16. The UAB unit (Department and Division) that is responsible for monitoring and managing the award funds and their organization code. The organization code is required.

  17. Billing/Collection Responsibility Designation: Select the appropriate responsible Group.

    • Department (PI/Award Manager) for Clinical Trials and Milestone-based Contracts

    • Grants & Contracts Accounting for Letter of Credit (LOC) Federal, Federal Pass-thru and reimbursement projects and scheduled payment projects.

  18. NOTE: Do not list Principal Investigator name or Sponsor name as keywords.
  19. Keywords: List a minimum of 3 scientific keywords that best describe your research or project.

  20. Will funds be leaving UAB? Indicate Yes (Y) or No (N). If yes, subcontract or consultant, or both if applicable. Please include the Statement of Intent or Letter of Collaboration (if applicable) or a letter of support for the consultant.

  21. Announcement ID No. - The Announcement or Solicitation number, PA, RFA, RFP, etc. in response to which a proposal is being submitted.

  22. Enter the URL address of the program name to which this proposal relates, e.g. Unsolicited R01 (if applicable).

  23. Purpose: What is the purpose of the grant or contract?

    Sponsored Research

    Definition: 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.

    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

    Definition: The Sponsored Instruction category 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

    Definition: Other Sponsored Activities are programs and projects financed by Federal and Non-Federal agencies and organizations which involve the performance of work other than instruction and sponsored research. Clinical Trials are 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
    • Any awards that are not Sponsored Research or Sponsored Instruction

    Included in this category are federal grants starting with the following letter or number:
    • G20 (Grants for repair & renovation of existing research facilities)
    • H-series (excluding HHSN which is sponsored research)
    • R13 (conference grant)
    • U13 (conference grant)

  24. Instrument Type: Check either contract or grant.

    A 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.

    NOTE: Contracts, like those provided by the federal government or industry sponsors, are subject to negotiated terms and conditions. A 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 signature by UAB, and if those terms and conditions are not acceptable, would require negotiation between the parties.

  25. Activity Description: If you select grant in #21, see the grant table below. Otherwise if you selected contract, see the contract table below:

    Grant Types

    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.
    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.
    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.
    Clinical Trial Grant 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 which 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)
    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.
    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 Types

    Type Description
    Individual Contract A written agreement between the institution and the sponsor which obligates both parties.
    Cooperative Agreement A written agreement between multiple parties in which the obligations flow between two or more parties.
    Clinical Trial Contract 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.
    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.
    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.
    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.
    Non Sponsor Funded Research Entity is providing either a product, material or equipment in lieu of funds.

  26. NOTE: CFDA # is not applicable to federal contracts or industry agreements.
  27. CFDA # (If applicable) - The Catalog of Federal Domestic Assistance contains detailed program descriptions for Federal Assistance programs. It only applies to federal grants and is usually on the notice of grant award or may be in the program announcement.

  28. If Clinical Trial was selected in #22, complete the information below:
    • Enter the CRO name (if applicable).
    • Select the appropriate source of the protocol and provide the protocol # and IND or IDE #.
    • Indicate if the CCTS (Center for Clinical and Translational Science) will be utilized.
    • Indicate if FAP has reviewed the project.
    • If registered on CT.gov provide the NCT number.
  29. Clinical Trial Phases

    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 Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.
    Post 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.


    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.

  30. Provide the Sponsor/CRO Contact Name, telephone number, email address, and sponsor's reference # for the contract if applicable.

  31. Project Requested Dates

  32. NOTE: Remember the dollar amount should reflect the new amount / increase and not include the previously awarded amounts.

  33. Enter the Direct and F&A (Indirect Cost) to show total funds requested. Select the applicable methodology in accordance with UAB's current F&A rate agreement.
     
    Select the F&A Rate Basis:

    NOTE: Modified Total Direct Costs, consisting of all salaries and wages, fringe benefits, materials, supplies, services, travel and subgrants and subcontracts up to the first $25,000.00 of each subgrant or subcontract (regardless of the period covered by the subgrant or subcontract). Modified total direct costs 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 and subcontract in excess of $25,000.00.

    • 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 which 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.

  34. Indicate if any F&A (indirect costs) are to be shared with a department other than the PI's primary appointment. Yes (Y) or No (N). If yes, complete and attach the Indirect Cost Revenue Redistribution Agreement.

  35. If this is related to any other agreements, please provide the related OSP Assigned Number (OSPAN), as applicable.
    • PMA (Project Master Agreement)
    • CDA (Confidentiality Agreement)
    • MTA (Material Transfer Agreement)
    • Non Sponsor Funded Research Project

  36. Review the Export Control guidelines and decision tree and answer the related question - Yes or No.

  37. Existing Intellectual and / or Tangible Property
    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.

  38. Intellectual Property Declaration
    Industry sponsored clinical studies are primarily testing arenas designed by and for the benefit of the sponsor: they are not opportunities to conduct research. Accordingly, opportunities for UAB researchers to conceive and/or reduce to practice new or serendipitous inventions are likely to be rare. Furthermore, if such inventions relate to the sponsor’s product, the sponsor is likely to require assignment of ownership rights and consequently subsequent commercialization revenue, if any. You need to inform UAB if you are willing to proceed with a study on that basis or not. Mark an X in either 1 or 2 and initial next to your entry.
    NOTE: UAB may designate multiple individuals as Project Director/Principal Investigator. All PD/PIs must sign the checklist and a multi PD/PI application must include a Leadership Plan and the PD/PIs must have a PD/PI role type in the NIH Commons. NIH Grants which do not allow multiple PIs will indicate that in the funding announcement.
    Signatures needed for proper walk through procedures:
    1. Principal Investigator/Project Director - PI 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.