AMP Core Lab – Procedures for Initiating a New Clinical Trial
Approval of clinical trial (CT)
Investigators must communicate with the Lab Director or Lab Manager about potential clinical trials well in advance of any 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.
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 describe the study design and type of testing required, the duration of the study and planned patient accrual, and the tentative start date. This information along with contact details of the investigator and study coordinator are documented in the Lab’s server-based Clinical Trials Log.
Pricing estimates are subject to the prior approval of the Business Office; this is necessary to help insure cost recovery and inclusion of appropriate overhead charges. Modifications to the study design that impact on testing will usually require reevaluation and new price estimates. Pricing provided for one trial will not usually apply to another.
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 online lab service requests, and/or arrange for transport of all case materials to and from the Lab.
Creating test protocols
All clinical trial specimens are accessioned, tracked, and reported in CoPath as a WCT specimen type. A specific test protocol is 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.
For some trials multiple specimens may be received for the same patient at different times during the study with different procedures performed on each specimen. In such cases the study coordinator must provide sufficient information on each order 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. It is never the responsibility of lab staff to determine the type of testing that applies to a given trial specimen.
Creating a project on the Webportal
Although all clinical trial specimens are accessioned in CoPath, cases can also 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, the 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, that indicates that the laboratory component has been completed.