Lower extremity arterial disease in patients with diabetes: a contemporary narrative review
Clinical Trials In-Depth
Investigator InitiatedWhen a PI becomes interested in working with a sponsor, or a sponsor contacts a PI regarding a project, a Confidential Disclosure Agreement (CDA) should be put in place between UAB and the sponsor, before any information is shared. A CDA will allow the parties to share and discuss confidential information about the project to enable them to determine whether to pursue it. For more information about CDAs, see the CDA page.
The first step when evaluating a clinical trial is to determine whether the PI or the sponsor wrote the protocol.
There are three scenarios for investigator-initiated clinical trials:
In the first and third scenarios, the sponsor should provide an agreement for investigator sponsored clinical trials, and in the second scenario, the other institution will provide an agreement to cover the project. If the sponsor of your project indicates that they do not have an agreement, please contact your OSP officer. You should never provide a contract to the sponsor.
Sponsor InitiatedMost sponsor-initiated clinical trials involve multiple investigators at multiple sites. When the parties agree that UAB will be a site, the sponsor will provide a clinical trial agreement (CTA). At this time, you will be able to begin the process of having the project and the agreement reviewed internally. Some sponsor-initiated clinical trials will be performed under a project master agreement (PMA) with the sponsor. In that case, the agreement the sponsor will provide will be a simple work order, as the significant terms of the agreement have already been negotiated between the parties.
The regulatory and financial aspects of clinical trials (no matter the protocol source) are handled exclusively by the PI's department staff, while the contract matters are handled by OSP. Ideally, the IRB/WIRB approval process, the budget negotiation, and the contract negotiation occur contemporaneously so that each is final at roughly the same point in time. For this reason, it is important that no submissions are made to IRB or OSP before the protocol is final. However, your project should be submitted for Fiscal Approval Process (FAP) review before it is submitted to OSP.
One important component of the regulatory aspect of a clinical trial is the informed consent document (ICF). The ICF explains the project to the subject in layman's terms, and also contains important information about how their health information will be used and how research-related injuries will be handled. It is always the department's responsibility to work with the UAB IRB to ensure that the information contained in the ICF is accurate and reflects UAB policy. Every clinical trial will require an informed consent document, which must be approved by the IRB and may be reviewed as well by the funding source.
The budget for a clinical trial will be a per-patient or per visit budget, with additional items like start-up costs and UAB Industry-Funded Clinical Trials Fees invoiced separately.
Once you have an agreement, a final protocol, and you've submitted to FAP, you should submit your clinical trial to OSP for review by emailing the required documents to This email address is being protected from spambots. You need JavaScript enabled to view it.. Upon completion of agreement negotiation, UAB procedure requires that the project have an IRB approval and CIRB release before the agreement can be signed by a UAB authorized signatory.
Required DocumentsThe required documents for a proper OSP submission for an industry sponsored clinical trial with a drug or diagnostic are:
The required documents for a proper OSP submission for an industry sponsored clinical trial with a device are:
NOTE: Before a clinical trial agreement involving a device can be executed, there will need to be a determination on whether or not a Hospital Letter of Agreement (HLOA) and a Non/Significant risk letter will be required. The Clinical Billing Review (CBR) group will assist in facilitating this review. If a HLOA is required, the agreement cannot be executed until OSP receives a copy of the agreement signed by all appropriate parties.
Tips for the Extramural Checklist & OSP SubmissionDisplaying Items By Tag: Adults
If you have the JAK2 V617F mutation, are aged 18-74 years old, do not smoke, do not have any known autoimmune disease, and attend medical checks at UAB regularly, you may be eligible for our study!This study focuses on better understanding how diet influences quality of life in MPN patients. We will test whether an anti-inflammatory food regime can help alleviate symptoms and decelerate disease progression.
Participants will meet with study staff to collect non-invasive samples, undergo anthropometric and metabolic measurements, and answer study related questionnaires. Samples to be collected include blood and stool samples.
Participants will be compensated $50 for each visit and providing samples if simply continuing their regular food intake, or $90 each month if trying an anti-inflammatory food regime for 3 months and completing the study visits and providing samples. Participants who adhere to an anti-inflammatory regime and would like to continue a further 9 months may be eligible to continue participating with a compensation of $90 per month. Study participants in all groups would receive information related to body inflammation, vitamin D levels, and metabolism if desired.
Total maximum compensation of $150, $270 and $810 depending on study group.
For more information, please contact us via phone or email at:Phone: 205-975-3752Email addresses: tmarquezlago@uabmc.Edu or mpn@uabmc.Edu
Displaying Items By Tag: Men
Are you between the ages of 18-60?The UAB Office of Psychiatric Research is actively recruiting participants for our studies and wants to connect with you on our research! Whether you are needing someone to talk to, or even have no history of mental health conditions and are just wanting to further knowledge within the medical and mental health field, we would love to get you involved!
Our studies can be broken down into two different categories:
1) TREATMENT STUDIES – Our Treatment Studies are designed to evaluate the effectiveness of new antidepressants on individuals living with Major Depressive Disorder or Treatment-Resistant Depression.
2) NON-TREATMENT STUDIES – Our Non-Treatment Studies do NOT involve testing a new medication or intervention. Instead, these studies focus on understanding behaviors and experiences of mental health conditions via interviews, tests, or surveys.
COMPENSATION IS PROVIDED!
For more information, please reach out to the UAB Office of Psychiatric Research at (205) 934-2484 or go to: https://tinyurl.Com/UABpsychiatricresearch and our team will be in contact with you shortly!
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