In-Depth Look at Clinical Trials

In-Depth Look at Clinical Trials

Office of Sponsored Programs Guidance In-Depth Look at Clinical Trials

In-Depth Look at Clinical Trials

Investigator Initiated

When 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:

  1. The first, and more common, is where a UAB PI writes a protocol for a clinical trial using a sponsor’s drug, device, or diagnostic and the sponsor agrees to fund the project and provide the drug, device or diagnostic. UAB is the only site conducting the trial, and agrees to provide the sponsor the study results or data in return for receiving the funding.
  2. The second scenario is where a PI at another institution (either alone or with the UAB PI) writes a protocol and gets funding from a sponsor. UAB would then be a subsite for the trial, receiving money and drug from the other PI’s institution.
  3. The third scenario is where the PI has written the protocol, but the company is only providing the drug, device, or diagnostic, and the funding is coming from another source. This is covered in more depth on the Non-sponsor funded projects page.

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 Initiated

Most 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 CPAP diagram provides a useful overview of the process for getting a clinical trial up and running at UAB. 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 IRB 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 osp@uab.edu. 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 Documents

The required documents for a proper OSP submission for an industry sponsored clinical trial with a drug or diagnostic are:

  • UAB Extramural Checklist [Form] [Instructions]
  • Responsible Personnel List [Form] [Instructions]
  • Editable Agreement (or Work Order, if applicable)
  • Budget
  • Final Protocol
  • Informed Consent

The required documents for a proper OSP submission for an industry sponsored clinical trial with a device are:

  • UAB Extramural Checklist [Form] [Instructions]
  • Responsible Personnel List [Form] [Instructions]
  • Editable Agreement (or Work Order, if applicable)
  • Editable Agreement
  • Budget
  • Final Protocol
  • Informed Consent

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 Submission

  • Question #4: Should always be “N/A.” Do not provide a deadline date (or use “ASAP”) for projects that are not proposals.
  • Question #20: A clinical trial will be classified as Other Sponsored Activities
  • Question #24: must be completed FULLY
  • Question #29: The OSP # for any related CDA with the funding source is now required. The effective date of the related CDA will be used to set up the at-risk account for your sponsor-initiated clinical trial account, so this information is critical.
  • Question #27: If the project meets the UAB definition of a clinical trial, it will be eligible for the 30% clinical F&A rate. The rate should be 30% and the base should be clinical. Otherwise the F&A rate will be the DHHS rate (link) for other sponsored activities and the base should be MTDC. To determine whether your project meets all the criteria for the reduced 30% rate, please consult the F&A decision tree.
  • The project will not be assigned for review until all required items are received in OSP.
  • If your project is complex, related to another ongoing project, or there are project-specific requirements (e.g. subcontracts) your OSP officer should be aware of in negotiating the contract, please feel free to include this information in a ‘notes to reviewers’ document at the time of your submission.