UAB defines a clinical trial as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
Examples of intervention include: drugs; small molecules; compounds; biologics; devices; procedures (i.e., surgery); delivery systems (i.e., face-to-face interviews); strategies to change health-related behavior (i.e., diet, cognitive therapy, exercise, development of new habits); or prevention, diagnostic or treatment strategies. A clinical trial always involves: (i) human subjects and (ii) the testing of an investigational intervention or the testing of an approved intervention for an investigational purpose.
The Food and Drug Administration (FDA) classifies a clinical trial of a drug based on the study's characteristics, such as the objective and number of human subject participants. There are five phases (see table).
Phase | Description |
---|---|
Phase 0 | Exploratory studies, involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (e.g. screening studies, microdose studies). |
Phase I | Studies that are usually conducted with healthy human subject participants and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted. |
Phase II | Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, human subject participants receiving the drug may be compared to similar human subject participants receiving a different treatment, usually an inactive substance, called a placebo, or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. |
Phase III | Studies that gather more information about safety and effectiveness by studying different human subject populations and dosages and by using the drug in combination with other drugs. |
Phase IV | Studies occurring after the FDA has approved a drug for marketing. These include post-market requirement and commitment studies that are required of or agreed to by the study sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use. |
This section covers clinical trials that are supported by for-profit companies like pharmaceutical companies or device manufacturers, the federal government, or non-profit organizations. An investigational new drug application (IND) or investigational device exemption (IDE) are the mechanisms by which regulatory authorities approve and monitor the testing of investigational drugs and devices in clinical trials.
When a clinical trial is labeled investigator-initiated (IIT), it means that the UAB Principal Investigator (PI) wrote the protocol, rather than the pharmaceutical company or device manufacturer. The PI has made the intellectual contribution to the project, and the pharmaceutical company or device manufacturer is providing only funding and/or the study drug, device, or diagnostic. If there is an FDA-regulated product involved and it is considered to be investigational, generally UAB/PI will hold the IND/IDE. UAB is the sponsor of the study for IIT clinical trials.
Sponsor-initiated clinical trials are those in which a sponsor (company/person), rather than the PI, writes the protocol and also provides funding and the study drug or device. If there is an FDA-regulated product involved and it is considered to be investigational, generally the sponsor will hold the IND/IDE.
Industry-sponsored and sponsor-funded IIT clinical trials that meet UAB’s definition of a clinical trial (see Clinical Trial F&A Flowchart) are eligible for the clinical F&A rate of 30%. All other clinical trials will be subject to the DHHS negotiated F&A rate (see UAB Rate Agreement) for other sponsored activities or applicable UAB policy, calculated on the Modified Total Direct Cost (MTDC) basis.
A Project Master Agreement (PMA) is an umbrella contract between UAB and another entity that sets the legal terms and conditions that will govern multiple studies/projects between those parties. A PMA facilitates faster approval of subsequent clinical trials or research projects because most terms and conditions, especially the most arduous, have already been negotiated. An attachment (e.g., exhibit, addendum, task or work order, etc.) to the PMA is ordinarily utilized to incorporate the scope or statement of work, budget and any additional terms specific to that study/project.
The Project Master Agreement (PMA) is a proposal type in IRAP. The OSP AVP is listed as the PI on all PMAs. If you are working on a project under a PMA you should see the referenced PMA or amendment by clicking the Related Agreements folder of the IRAP proposal record. You will, however, not be able to open the PMA record as only the OSP AVP is listed on it as Responsible Personnel. For access contact the OSP officer supporting your department, division or school.
Required Documents Search Tool
List of active PMA records at UAB (requires login)
A teaming agreement is an agreement between two or more parties to pool resources to obtain and perform a government contract. A typical teaming relationship for UAB involves a large corporation as prime contractor collaborating with UAB as a subcontractor.
Teaming agreements are usually requested by the prime contractor at the proposal stage. Teaming agreements should be submitted to the OSP with the UAB Expedited Checklist as soon as requested as they require review, routing, negotiation and execution by a university official with binding signature authority. Primary areas where language is of concern includes exclusivity, duration of the agreement, agreed outcomes if the submission results in award and negotiation of the teaming relationship versus the subcontract terms.
An Interagency Personnel Agreement (IPA) is a funding mechanism for the VA to reimburse the Department at UAB for a portion or all of the salary and fringe benefits of a UAB employee (faculty or non-faculty) working on sponsored research projects funded by the VA. The goal of this type of agreement is to strengthen the relationship between UAB and the VA by the temporary assignment of UAB skilled personnel to work with the VA; the goal being a mutually beneficial outcome for both parties, e.g. the use of new technologies to solve governmental problems and provide experience to the UAB employee that will enhance his or her performance in their job at UAB.
IPAs can be made for a period of up to two (2) years and can be extended for an additional two (2) year period. Please allow at least thirty (30) days from the date the IPA agreement is generated by the VA for the processing and execution of the agreement.
Any significant changes in an employee’s duties, responsibilities, salary, or work location must be recorded as a modification to the original agreement. Minor changes, such as annual salary increases or change in benefit rates are processed via a standard VA memorandum.
VA IPA Initiation and Process
The VA Investigator notifies the VA and the Department at UAB of the UAB employee they would like to place on an IPA.
- Post Docs and Graduate Students cannot be on an IPA.
- The UAB employee must be a 01 or 03 status employee for at least 3 months or 90 days.
- Those residing in the US on a student visa cannot be placed on an IPA.
- The Department initiates the process with a letter or email to the VA.
- The letter includes the employee’s name, salary, fringe, work location and supervisor.
- The VA generates the agreement and sends it to the Department.
- The Department has the employee sign an original and generates a UAB checklist.
- The Department submits the IPA and Checklist to the OSP.
- OSP Data Entry enters the submission into IRAP. A project number (OSP Assigned Number) is automatically assigned.
- OSP reviews and signs the UAB checklist and the IPA and then calls the VA for pick-up of the original.
- After being signed by the VA, the fully executed original is sent to the OSP.
- Fully executed copies are distributed to the PI, Award Manager and G&C Accounting.
VA IPA Termination
When terminating an IPA, the VA must be notified as soon as possible so that the termination memorandum can be generated and the account closed.
- The Department notifies the VA of the request to terminate.
- The VA issues a termination memorandum.
- OSP reviews the termination memorandum and forwards to G&C Accounting to close the account.
Please direct questions regarding VA IPAs to your officer or to
NOTE: The VA will not pay indirect costs on an IPA.
The grant application from UAB should only list the UAB institutional base salary and request the salary in proportion to the effort devoted to the project.
A signed copy of the VA MOU only (Other Support is not required at this time) must be submitted with the application to OSP for a new, competing or resubmission grant application and with a progress report if there is a change in responsibilities from the original submission. The MOU, including Other Support, must be updated with:
- a Just-in-Time (JIT) submission,
- each significant change (i.e. change in VA appointment or significant change of 25% or greater in research commitment) of the faculty member’s responsibilities or effort or
- at the very least annually if there was no significant change (one year since the last revision).
All faculty members listed on a proposal who have a joint UAB/VA appointment must:
- disclose the joint appointment on the budget justification of the application, and
- complete the UAB/VA MOU in accordance with the above paragraph.
Cost Sharing: Please note that any VA effort expended on a sponsored project at UAB must be approved by the VA and disclosed to the sponsor. Any such effort does not fulfill any mandatory cost sharing requirements even with sponsor approval. Any effort should be referred to as effort expended on a VA appointment and must never be referred to as “cost sharing”. It is not acceptable to cost share with other federal funds unless it is specifically authorized in the appropriation.
Information in IRAP – Search for Proposal Type of VA MOU or amendment.