July 13 2021
By Whitney Jacobson, RN, CCRP, OCN
Advocate Aurora Research Institute™| Aurora St. Luke's Medical Center
Pathology and biospecimen collections are commonplace in many oncology clinical trial protocols. Preparation is essential to successful specimen collection and shipping. The following are several recommendations and best practices for compliance with the study protocol.
Protocol Review
A patient may not be identified for months after protocol training. Once a patient is identified by the study team, an early thorough review of the study protocol is imperative. Be sure to look for any eligibility criteria regarding pathology central review to confirm specimen availability before approaching patients. Are specimen kits and shipping labels provided by the study or will you use institutional supplies? What’s the turnaround time for kit delivery and how could this turnaround potentially impact enrollment and treatment start date? Confirm you have the supplies on-site to build a kit from institutional supplies. Do you have access to systems for logging specimens? Lastly, carefully read through the collection time points and note any collection windows. Will specimens be shipped same day or can they be frozen and batch shipped? What days are sites allowed to ship specimens? Early clarification, if needed, with the study team will help minimize stress or potential issues.
Team Communication
Communication with all stakeholders is critical! Depending on your site’s operations, you may involve and interact with several individuals or groups to coordinate pathology and biospecimen review, collection, processing, and shipping. Consider developing a standardized workflow for requesting pathology review for research specimens (i.e., designating central pathology contacts, submit pathology requests via email vs. electronic medical record, use a template for pathology requests). If a phlebotomist and/or medical lab technician will be assisting, it’s a good idea to collaborate with them before the visit date to ensure they understand protocol requirements, have adequate staffing resources, and any questions have been answered. If the protocol requires a post-dose blood collection, ensure the clinical team is aware so the patient can be scheduled at an appropriate time to accommodate post-dose collections
Prepping the Kit
Re-review the specimen kits and corresponding specimen guidelines at least a couple days before the patient visit. Determine how the specimen collection supplies need to be labeled (i.e., are labels provided or do you need to create labels?), if any requisition forms need to be printed or can be pre-filled to save time, and whether shipping labels can be created in advance. Make a copy of the shipping label for source documentation. Collect the supplies needed to ship the specimens. Do you have the proper packaging materials? Taking these steps before the visit date will help improve efficiency on the day of.
Source Documentation
So, the pathology and biospecimens have been collected and shipped without a hitch. What’s next? Be sure you have the following available for source documentation: shipping manifests, requisition forms, shipping labels with tracking number, samples received notifications, tracking updates, documentation of collection date and time, applicable correspondences with study and site personnel, etc.