AMP Core Lab – Procedures for Initiating a New Clinical Trial
Approval and pricing for WU clinical trials (CT)
Prior Communication and Approval. Investigators must communicate with the Lab Director or Lab Manager about potential clinical trials well in advance of grant submission and any trial start date. Our decision to support a trial hinges on a number of factors including: departmental priorities, identification of an appropriate study pathologist by the investigator, compatibility with existing clinical workflows, and the projected workload for the lab. AMP Core Labs requires identification of one or more study pathologists.
Considerations for Standard of Care Testing. It is important to understand that the AMP Core Labs does not support primary testing for standard of care biopsies performed at the Medical Center. For studies involving such specimens, it is essential to consult with the Lab Manager for BJH Surgical Pathology. With appropriate IRB approvals, investigators can arrange to obtain the blocks after sign-out. These materials could then be transferred to the AMP Core Labs for the preparation of additional slides and/or non-standard testing.
Required Study Summary. If it is determined that the trial can be supported a written summary of the trial must be provided by the investigator. The summary should briefly describe the study and the study design. It must also indicate the type of testing required, the duration of the study, the planned patient accrual, and the planned start date. Significant changes will require submission of a revised summary.
Price Estimates. A formal price estimate will be generated. Modifications to the study design that impact on testing will usually require reevaluation and new price estimates, and pricing provided for one trial will not usually apply to another. Multi-year projects will be charged current costs as reevaluated annually. Given that Ventana reagent costs alone increase by 3% per year, an annual increase of up to 5% should be projected. The department does not subsidize clinical trials.
Test Interpretation. Prices for tests include routine quality control, but do not cover interpretive services. These are best covered by allocating appropriate effort for the study pathologist on the grant. If these services cannot be covered by the grant, prior arrangements must be made with the study pathologist and Pathology & Immunology Business Office. Digital imaging or molecular services will require separate estimates.
Clinical trial specimens are often initially received by the Tissue Repository, but can also be received by the trial office from participating medical centers. Regardless of how the specimen will enter the system the investigator must identify a study coordinator who will serve as the primary contact, assume responsibility for generating any lab service requests, and/or arrange for transport of all case materials to and from the Lab, including transport to the study pathologist.
Clinical trial materials must be delivered during workday hours to the Lab Services Coordinator in the West Building, Room 4715. All trial specimens must be accompanied by a pre-approved specimen requisition (inventory) and all specimen containers must be appropriately labeled with predetermined identifiers.
Creating test protocols and requisitions
Test Protocols. All clinical trial specimens are accessioned, tracked, and reported in CoPath as a WCT specimen type. One or more test protocols are created in CoPath with the assistance of the study coordinator or investigator and the CoPath administrator. The test protocol always includes the assigned study name, but may include other information if more than one specimen is to be received for a given patient.
Specimen Requisitions. Requisitions must be carefully designed to reflect the requirements of the clinical trail. For some trials multiple specimens may be received for the same patient at different times during the study with different tests on each specimen. In such cases the study coordinator must provide sufficient information on each requisition to insure that the appropriate protocol is used. The terminology used for each successive specimen should be standardized and documented in the Clinical Trials Log at the time of setup. Likewise, if there are multiple arms to the study the specimen requisition must be designed to allow unambiguous ordering of the required test(s). It is never the responsibility of lab staff to determine the type of testing that applies to a given trial specimen.
Any significant change in the study protocol will usually require changes in test protocols and/or specimen requisitions. Such changes require planning and must be arranged well in advance of specimen delivery.
Creating a project on the Webportal
Although all clinical trial specimens are accessioned in CoPath, cases can with prior approval be accessioned into the Webportal-based ordering and tracking system. This allows the study coordinator to generate a requisition for trial specimens that are not initially received by the Tissue Repository and permits the study coordinator to track the status of specimens online.
The Lab Manager interacts with the clinical trial coordinator to create a Webportal project with an appropriate trial name, shared user name and password, and contact information for any electronic notifications. The same project is used for submitting online orders for each patient specimen associated with a given clinical trial.
Special considerations for receiving and accessioning
For some trials a specimens may be received as more than one part, with each part receiving its own CaTissue number. In this situation, the CaTissue number for the first part (A) is used as the first name according to the CT specimen naming convention. Other parts are described and identified in the gross description. In some cases, the last name corresponds to the trial name, with the first name representing some other participant identifier. The Lab does not offer complex grossing functions or distribute received specimens to other laboratories.
For specimens that involve pathological interpretation, the sign-out of the case occurs when the pathologist signs-out the case in CoPath. For specimens that do not, a technical sign-out occurs when the last part of the order is completed. The Lab will provide one email notification to a predetermined individual, usually the study coordinator (or a group of individuals) that indicates that the laboratory component has been completed.