Unlocked Word Version of the Agreement
All industry agreements (including applicable exhibits, attachments, appendices, etc.) provided to UAB must be in the form of an unlocked and editable Microsoft Word document. Because UAB has multiple levels of internal review that may include privileged communications that are not shared with external parties, UAB will not participate in contract negotiations if a template is provided in a locked or otherwise uneditable format.
Please be assured that UAB: (1) will not make edits without both parties being made aware of any such changes; (2) will track all edits in “track changes” mode; and (3) will provide a redlined copy reflective of any and all changes made. UAB’s integrity is of the utmost importance in all contractual negotiations.
Study Start-Up Fees
Study start-up fees are non-refundable and due upon (1) full execution of the agreement and (2) confirmation of IRB and/or other regulatory approval(s) (as applicable). Site initiation may not be a trigger for payment of start-up fees because doing so places UAB at risk of not recovering its start-up expenses in the event a sponsor decides not to initiate UAB as a site. Without site initiation, a sponsor would have no obligation to pay start-up costs incurred by UAB, which would equate to UAB subsidizing a sponsor’s research as most start-up activities have occurred before the site initiation. As a non-profit public entity of the State of Alabama, UAB is prohibited from subsidizing a for-profit entity’s research.
Existence of an Agreement Cannot Be Confidential
While UAB can agree to keep certain terms and conditions of an agreement confidential, UAB cannot accept contract language that requires the existence of an agreement to remain confidential. As a non-profit public entity, UAB is subject to the State of Alabama’s Public Records Laws and could be required to disclose certain information relating to the agreement, such as the existence of the agreement, the sponsor’s name, the investigator’s name, the total funding amount received, the title of project, and the project period. UAB’s position is that confidential information owned by a third party is protected from disclosure pursuant to public policy exemptions, and UAB will use its best efforts to protect a sponsor’s confidential information from disclosure as appropriate under the law.
Prime Agreement as an Exhibit to an Incoming Subcontract
UAB cannot accept an incoming industry subcontract where the prime agreement between the sponsor-institution and funding source is included as an exhibit and/or attachment to, is referenced in, or is otherwise incorporated into the subcontract. UAB is not a party to the prime and, as such, will not accept responsibility for reviewing the terms of the prime in order to determine whether a provision is applicable to UAB’s conduct in the relevant study. Instead, UAB requires that any terms or conditions from the prime that are specifically applicable to UAB’s conduct of the study be included in the body of the subcontract provided by the sponsor-institution and that any language not applicable to UAB be removed from the subcontract agreement between UAB and the originating institution.
Navigating the Clinical Protocol Activation Process for Industry-Written and Sponsored Clinical Trials
The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow diagram). Each step is very important and establishes a good foundation for the next. Note that as you navigate the process, while some steps are serial, most are parallel and there is a true flow to the process to get the desired outcome, which is to have all tracks of the process completed simultaneously.
This document is a living document and the flow is subject to change as some systems change or processes are streamlined. Please don’t hesitate to submit any questions, suggestions, or comments you may have to the Clinical Trials Administrative Office at
GLOSSARY TERMS
|
|
FLOWCHART
STEPS
-
DETERMINE INTEREST
Initial Contact by Sponsor
- CDA or NDA required?
- Information about CDAs and the corresponding submission documents/process are available on OSP’s website.
- CDA or NDA required?
-
ASSESS PROTOCOL
Assess Protocol to determine interest, opportunity, resources, and determine if planning to proceed. If yes –
- Determine activities and related locations
- Identify all potential study personnel
- Budget considerations, will the protocol utilize any of the following:
- Center for Clinical and Translational Science (CCTS) services
- Category A or B Devices
- Clinical billable services (services provided and/or billed by any UAB Health System location)
- Other service providers (Dermatology Research, Ophthalmology, Radiology Research, etc.)
- Any other departmental costs (personnel, file storage, additional review or start-up fees for other service providers (BMT/Apheresis or Pharmacy)
- Special reviews/approvals required for the protocol:
- Special reviews/approvals - potentially hazardous agents:
Radioisotopes Microbial agents Recombinant DNA/RNA molecules Toxic chemicals Gene Therapy Toxins Nanoparticles Experimental Drugs Vaccines Carcinogens Mutagens Teratogenics
- Special reviews/approvals - potentially hazardous agents:
- Obtaining anatomic pathologic materials cells, tissue or organs (from any site) or clinical pathologic materials (serum, plasma, cerebrospinal fluid or non-tissue-based microbiologic specimens)?
- UAB cancer patients involved?
- Study conducted at any of the following locations/sites? (UAB Hospital, Highlands, Kirklin Clinic, Children’s Hospital, Eye Foundation, Jefferson County Department of Health)
- Participants involved with contagious infections at UAB or Children’s Hospital?
- Dispensing of drugs to participants at UAB or Children’s Hospital involved?
- Determine activities and related locations
-
REGISTER FOR ‘SINGLE IDENTIFIER’
Process currently being implemented across campus. More information coming soon.
-
SUBMIT FOR SPECIAL REVIEWS (as applicable)
Conflict of Interest
- Disclosures must be submitted to the Conflict of Interest Review Board (CIRB) by the Principal Investigator and any other person who is responsible for the design, conduct or reporting of the research including anyone who is involved in the informed consent process for human studies. Note: Conflict of interest disclosures must be submitted to IRB and will be forwarded to WIRB. For questions, call CIRB at 975-9691 or forward to
This email address is being protected from spambots. You need JavaScript enabled to view it. .
- Department specific review, submit Protocol Oversight Review Form (FOR205) using departmental letterhead
- OCCC Clinical Trials Review Committee (CTRC) – protocols that involve cancer patients at UAB must be submitted to the CTRC for review and approval (contact Aparna Tamhane 975-9877 or
This email address is being protected from spambots. You need JavaScript enabled to view it. for information and submission forms)
- Registering your project with Radiation Safety
- Registration for Recombinant DNA Research
- Institutional Biosafety Committee (IBC)
- Gene Therapy Project Review Panel
- Report of the Project Review Panel (FOR214)
- Vaccine Trials Project Review Panel (FOR201)
- PORF for Vaccine Trials using departmental letterhead
- UAB Hospital at 934-5324
- Children’s Hospital at 939-9265
- UAB Hospital
- Complete the Release of Drugs for Human Research Use-UAB Pharmacy (FOR217)
- Send this form along with a copy of the Study Protocol, Investigator’s Brochure (if available), and Pharmacy Manual (if available) to
This email address is being protected from spambots. You need JavaScript enabled to view it. - NOTE: allow 7-10 days for review
- Children's Hospital
- Submit a copy of the study protocol to: TCHA Pharmacy Department Attn: Adrienne Travis, 1604 6th Ave South, Dock A, Birmingham, AL 35233
- TCHA pharmacy completes the TCHA Pharmacy Release Form (FOR218) and forwards to the Pharmacy director for signature.
- TCHA notifies the coordinator when forms (3 copies) are ready for pick-up.
- Principal Investigator signs all copies and returns 2 copies to TCHA pharmacy
- Complete and sign the Anatomic Pathology Release Form (FOR215) and submit along with a hard copy of the study protocol to the Office of the Director for Anatomic Pathology, Kracke Building, Room 506.
- Complete and sign the Clinical Pathology Release Form (FOR216) and submit along with a hard copy of the study protocol to the Office of the Director for Clinical Pathology, West Pavilion, Room P230.
- The Principal Investigator is contacted by phone once the form is ready for pickup.
- Disclosures must be submitted to the Conflict of Interest Review Board (CIRB) by the Principal Investigator and any other person who is responsible for the design, conduct or reporting of the research including anyone who is involved in the informed consent process for human studies. Note: Conflict of interest disclosures must be submitted to IRB and will be forwarded to WIRB. For questions, call CIRB at 975-9691 or forward to
-
CREATE EXTRAMURAL CHECKLIST FOR OSP
Submit all required documents, Checklist must be submitted with signatures, other documents must be submitted electronically to
This email address is being protected from spambots. You need JavaScript enabled to view it. .- Completed UAB Extramural Support Checklist
- Responsible Personnel List (RPL)
- Electronic version (Word) of the clinical trial agreement/contract
- Final protocol
- Budget (draft or final) - see also Industry Budget Template (if applicable)
- Informed Consent Form (draft or final)
- Investigator Agreement (if applicable)
- Hospital Letter of Agreement for Category B Device Trial (if applicable)
- Cost-sharing Form (if applicable)
This email address is being protected from spambots. You need JavaScript enabled to view it. .NOTE: Negotiation of contract terms occurs in parallel with department budget negotiations; however, an executed contract is contingent on having a finalized budget, CIRB release and IRB approval.
-
DRAFT CONSENT FORM AND PREPARE IRB SUBMISSION
Draft IRB submission and Consent Form for applicable review board Note: Projects to be reviewed by WIRB are NOT forwarded until CIRB release is issued.
-
DEVELOP PRELIMINARY BUDGET AND CREATE CBR SUBMISSION
If using -
- CCTS clinical services, (CRU) (NOTE: keep in mind to notify OSP of this decision as negotiations with Sponsors requires special contract language)
- Complete CCTS Registration Form and include the following in the submission:
- Schedule of Events (highlighting all services you wish CCTS to provide)
- Consent Form(s)
- Protocol (Grant application, sponsor protocol, study group protocol)
- Complete CCTS Registration Form and include the following in the submission:
- Category A or B devices?
- Complete a Clinical Billing Review (CBR) Submission Form, include required documents, and submit to
This email address is being protected from spambots. You need JavaScript enabled to view it. .
- Complete a Clinical Billing Review (CBR) Submission Form, include required documents, and submit to
- Other service providers?
- Submit to applicable service providers (protocol, study manuals and department request form)
- Boshell Diabetes CV MRI – Trina Corbitt at
This email address is being protected from spambots. You need JavaScript enabled to view it. - Civitan Functional Neuroimaging Lab – Dr.
This email address is being protected from spambots. You need JavaScript enabled to view it. , cc: Autumn Alexander,This email address is being protected from spambots. You need JavaScript enabled to view it. - Dermatology Research –
This email address is being protected from spambots. You need JavaScript enabled to view it. - UAB Hospital Research Pharmacy – Chris Chapleau
This email address is being protected from spambots. You need JavaScript enabled to view it. and complete the UAB Pharmacy Release Form (FOR217) - Ophthalmology Research, Contact Karen Searcey at
This email address is being protected from spambots. You need JavaScript enabled to view it. and complete the Ophthalmology New Account for Ophthalmology Research Exams (price request form) - Radiology Research (contact:
This email address is being protected from spambots. You need JavaScript enabled to view it. ) Include the appropriate Radiology forms, study protocol, and if applicable, study-related radiology manuals. - Tissue Procurement – Kathy Sexton,
This email address is being protected from spambots. You need JavaScript enabled to view it. - Bone Marrow Transplant (BMT)/Apheresis –
This email address is being protected from spambots. You need JavaScript enabled to view it.
- Boshell Diabetes CV MRI – Trina Corbitt at
- Submit to applicable service providers (protocol, study manuals and department request form)
- CCTS clinical services, (CRU) (NOTE: keep in mind to notify OSP of this decision as negotiations with Sponsors requires special contract language)
-
CBR SUBMISSION
Does the trial include Clinical Billable Services? If so, please submit through CBR.
There are four submission types: Full, Device, Amendment, and Feasibility. Complete the CBR Submission Workbook and the relevant forms included (as listed below). After completion, submit toThis email address is being protected from spambots. You need JavaScript enabled to view it. .- Checklists for each Submission Type
- CBR Submission Form
- Laboratory Form (if applicable)
- Flow Cytometry Form (if applicable)
- Device Form (if applicable)
- Complete Attachments (as applicable)
- Billing Plan (for Full, Device, Amendment)
- CTAW (for Feasibility Requests only)
- Upload the following (or attach to submission email)
- Final Protocol (or HSP)
- Draft Consent
- Completed Billing Plan
- Draft Sponsor Budget (if applicable)
- Lab Manual (if available)
- If Device Trial, include
- Draft Clinical Trial Agreement
- CMS Approval Letter
- FDA Letter with CMS Category
-
SUBMIT FOR CMS REVIEW (if applicable)
Category A or B devices that are investigator-initiated or with an FDA letter date prior to 01/01/2015?
- Submit protocol, IRB approval letter, approved consent and FDA letter to the Office of Clinical Billing Review at
This email address is being protected from spambots. You need JavaScript enabled to view it. . - Upon receipt of CMS approval letter, the Office of Clinical Billing Review will forward a copy to the PI/Research Coordinator.
- Submit a copy of the CMS approval letter with your submission to the Office of Clinical Billing Review at
This email address is being protected from spambots. You need JavaScript enabled to view it. .
- Submit protocol, IRB approval letter, approved consent and FDA letter to the Office of Clinical Billing Review at
-
COMPLETE ONCORE SUBMISSION IN REDCAP
For trials that include clinical billable services through the UAB Health System, an OnCore calendar must be requested here.
-
CREATE RESEARCH STUDY SUMMARY FOR POWERTRIALS
All trials being conducted through the Clinical Trial Management System (OnCore) must have a Research Study Summary generated and submitted as a PDF to
This email address is being protected from spambots. You need JavaScript enabled to view it. for posting within the Cerner EHR for patient-safety purposes at the point of care. -
SUBMIT TO GREENPHIRE
Unless utilizing University checks for the payment of participants (or an exception is secured), a request should be submitted to Financial Affairs via
This email address is being protected from spambots. You need JavaScript enabled to view it. to set-up a trial in Greenphire, the University’s participant payment system. You may find additional information on Greenphire at the CTAO site. -
RECEIVE PENDING ACCOUNT FROM GCA
Grants & Contracts Accounting will automatically send a Pending Account to the designated Award Manager on the OSP Extramural Checklist so that the Department may begin allocating expenditures (including faculty and staff effort) to the trial’s appropriate account. These expenditures must be applied in a reasonable timeframe to avoid delays in the execution of the contract.
-
NEGOTIATE FINAL BUDGET (Department Administrator)
Department will negotiate final budget with the industry sponsor.
-
RECEIPT OF IRB, CIRB APPROVALS
Note: If the commercial sponsor requires compliance with ICH-GCP, UAB’s WIRB liaison will not release the WIRB approval required under IRB POL005 without confirming that the UAB key personnel listed on the WIRB Initial Review Submission Form have completed the appropriate training and the training is documented in the Blazer ID Enabled Dissemination/Recognition of Official Content (BEDROC).
UAB’s Conflict of Interest Review Board (CIRB) will notify OSP when the project has been reviewed against UAB’s Conflict of Interest Policy and will provide OSP notification that “it is OK to release funds upon award” as approval.
Note: In the vast majority of industry sponsored clinical trials at UAB the central IRB for your project will be WIRB. There is a requirement for CIRB review and release prior to the WIRB application being forwarded by the UAB WIRB liaison to WIRB for review and approval. The UAB WIRB liaison must receive and will review the statement of conflict or no conflict from CIRB ensuring that it matches the investigator WIRB Initial Review Submission Form. If your industry sponsored clinical trial meet(s) the criteria for review by UAB IRB, CIRB release is not a requirement for review and approval, but it is a requirement for OSP to issue your award.
-
SUBMIT FINAL BUDGET TO OSP
Once budget negotiations are concluded the department will notify OSP that the budget is final, providing OSP with the agreed upon budget in the sponsor’s per patient/per visit format. The internal budget should be forwarded to OSP at this time.
-
OSP CONTRACT EXECUTED
Once OSP has negotiated the terms and conditions of the contract, receives approval from the UAB IRB, receives communication from CIRB that the project is “OK to award”, and is informed by the department that the budget is final, receives the Hospital Letter of Agreement (HLOA), if applicable, and receives the final agreement from the company, the contract will be presented for institutional signature.
Note: In many instances the sponsor requires UAB to sign the contract first. As a result, the UAB executed documents must be returned to the sponsor for counter signature prior to the award being distributed.
-
OSP RELEASES FINAL AWARD TO GCA, PI, AWARD MGR, AND CONTACT PERSON
OSP will issue the final award and the PI, contact person, award manager and Grants and Contracts Accounting (GCA) will receive a notification email. The award will consist of the contract (terms and conditions of the project), the internal budget, and any third party documents, e.g. Letter of Indemnification (LOI), required to ensure that UAB is indemnified in accordance with its policy (LOI required when indemnification is not included in the contract).
Note: Due to administrative process it may take GCA up to an additional 5 days to process this award into an active account. If you have additional questions about the status, please contact Tina Ealy in the Grants and Contracts Accounting Department at 934-9388 or
This email address is being protected from spambots. You need JavaScript enabled to view it. . -
SCHEDULE SITE INITIATION VISIT
Work with study sponsor to schedule initial site visit.
Effective April 1, 2020, the Third Party Determination Form will be a required document at the proposal stage for any federal grant that includes one or more subawards. Below is a description of the federal requirement:
Subrecipient vs. Contractor
Determinations are made on a case-by-case basis at the proposal stage. A Subrecipient vs. Contractor Determination Form is to be completed for each subrecipient. Before a proposal is submitted to an agency, OSP will make the final determination using the recommendations from the Third Party Determination Form.
It is important to differentiate between subrecipients and contractors before entering into an agreement with a third party organization performing a portion of UAB’s research project. This classification will determine the type of legal agreement as well as the type of monitoring required for the relationship. Misclassification may result in delays in subaward processing, as well as inclusion of incorrect facilities and administrative costs (F&A), leading to significant budgetary errors. UAB follows the requirements in the OMB Uniform Guidance (2 CFR 200), Section 200.330 to determine subrecipient or contractor status.
A subrecipient relationship may be appropriate when many of the following factors are present:
- The organization’s SOW represents a substantive and intellectually significant portion of UAB’s research project.
- The organization participates in a creative way in designing and/or conducting the research.
- The organization retains some element of programmatic control and discretion over how the work is carried out.
- The organization makes independent decisions regarding how to implement the requested activities.
- A principal investigator has been identified at the organization and functions as a “Co-Investigator.”
- There is an expectation that the organization will retain ownership rights in potentially patentable technology or products produced in the course of fulfilling its SOW.
- Publications may be created or co-authored at the organization.
- The organization assumes responsibility for adherence to applicable sponsor program compliance requirements.
A contractor relationship may be appropriate when many of the following factors are present:
- The organization is providing specified services in support of, or ancillary to, UAB’s research project.
- The organization has not significantly participated in the design of the research or project itself, but is implementing the research plan or project activities of the UAB investigator.
- The services are performed in the organization’s normal course of business and marketed to a range of customers.
- The organization makes little or no independent decision-making in the design and/or conduct of the research being completed.
- The expectation is that the work will not result in patentable technology that would be owned by the organization.
OMB Uniform Guidance allows grantees to use judgment in determining whether a relationship is that of subrecipient or contractor. Not all of the characteristics listed above will be present. Conversely, the presence of many of the characteristics is not necessarily determinative. Thus, the substance of the relationship is more important than the form of the agreement. UAB PIs are required to analyze the substance of the relationship with their subrecipients and note their recommendations by completing the Third Party Determination Form and submitting it to OSP at the proposal stage.
Non-Profit / Foundation Resources
- American Heart Association (AHA) Funding Opportunities
- Patient Centered Outcomes Research Institute (PCORI) Funding Opportunities
- American Association of Cancer Research (AACR) Funding Opportunities
- Foundation Center - Foundation Stats
Other Non-Profit / Foundation Opportunity Websites
- American Academy of Pediatrics
- American Cancer Society
- American Diabetes Association
- American Federation for Aging Research
- American Hearth Association - National
- Amyotrophic Lateral Sclerosis Association
- Bill and Melinda Gates Foundation
- Burroughs Wellcome Fund
- Cancer Research Institute
- Crohn's and Colitis Foundation
- Commonwealth Fund
- Cystic Fibrosis Foundation
- Damon Runyon-Walter Winchell Cancer Research Fund
- Doris Duke Charitable Foundation
- Elizabeth Glaser Pediatric AIDS Foundation
- The Foundation Fighting Blindness
- Helen Hay Whitney Foundation
- Hereditary Disease Foundation
- Howard Hughes Medical Institute
- Human Frontier Science Program
- Leukemia and Lymphoma Society
- The Medical Foundation (Charles A. King Trust)
- Mellon Foundation
- Michael J. Fox Foundation
- National Alliance for Research on Schizophrenia and Depression
- Oak Foundation
- Robert Wood Johnson Foundation
- Special Programme for Research and Training in Tropical Diseases
- Susan G. Komen
Other Non-Profit / Foundation Fellowships
- Arthritis Foundation Postdoctoral Fellowship
- Cancer Research Institute Fellowships
- Cooley's Anemia Foundation
- Damon Runyon Cancer Research Fund
- EMBO Postdoctoral Fellowships
- Helen Hay Whitney Foundation Research Fellowships
- Human Frontier Science Program Fellowships
- Immune Deficiency Foundation Novartis Fellowship
- Irvington Institute for Medical Research Fellowships
- Jane Coffin Childs Memorial Fund for Postdoctoral Fellowships
- Juvenile Diabetes Foundation International
- Life Sciences Research Foundation Fellowship
- Lupus Foundation on America Fellowship
- National Multiple Sclerosis Society Postdoctoral Fellowships
The UAB Office of Sponsored Programs non-profit/foundation team supports the UAB research community by reviewing and submitting grant applications to non-profit and foundation organizations, and reviewing and negotiating agreements for execution.
The non-profit/foundation team reviews grant application, contracts, non-sponsor funded agreements, collaboration agreements, and data use agreements, including those from other non-profit educational institutions.
The UAB OSP non-profit/foundation team is led by Associate Director - Non-Profit/Foundation Area. Information concerning your nonprofit/foundation officer and specialist can be found in the Find Your Officer Tool.
Required Documents for nonprofit/foundation/institution submissions can be found at the Required Documents Tool.
Reminders
- When submitting your nonprofit/foundation grant application, you must include the RFA (Research Funding Announcement) of the opportunity for which you are applying.
- Even if the application was completed electronically, you must submit a copy of the completed application with your OSP submission.
- For Non-Profit submissions only, UAB will accept a reduced IDC rate if the sponsor has a published and universally-applied policy confirming their limited rate. You must provide this information to OSP with your submission package.
- Non-Profit proposals must go through OSP for review at the proposal stage, even those that do not require an institutional signature or electronic approval. Do not wait until the award stage to make your initial submission to OSP.
- What do I do if the sponsor requires proof of governmental or 501(c)(3) status?
Instructions from the UA System can be found here.
An IRS letter of determination can be found here.