Feb. 1, 2016:

In this month’s Q&A, Big Ten Cancer Research Consortium (Big Ten CRC) Administrative Headquarters addresses common questions related to correlative research.

In what aspects of a clinical trial are correlative research managers at Big Ten CRC Administrative Headquarters able to assist?

As clinical trials continue to increase in complexity and further emphasize translational science, the collection of correlative specimens and the succeeding specimen analysis becomes ever more important. To ensure this process is carried out effectively, the correlative managers act as the point of contact for sites to answer any correlative questions that may arise. Correlative managers also assist sponsor investigators with several functions, including the creation of the correlative budget for a clinical trial and helping to identify laboratories and researchers to perform critical analyses. In addition, for all clinical trials involving correlative specimen collections, the correlative managers create study specific correlative specimen collection kits and the portion of the Study Procedures Manual that instructs participating sites on how to collect, label, process, store, and ship specimens. Finally, assistance is provided on how to enter biospecimen data into the electronic data capture system at Big Ten CRC Administrative Headquarters.

Why am I provided a Study Procedures Manual along with the protocol?

A Study Procedures Manual includes information that is specific to each trial. The Correlative Laboratory Procedures portion of the manual outlines in detail the instructions for collecting, processing, labeling, storing, and shipping each type of correlative specimen. This manual also includes the specimen submission forms that must accompany each specimen. It is important to follow the instructions outlined in the Study Procedures Manual for all correlative specimen collections to ensure consistency is achieved across all participating sites.

Why am I instructed to use only the correlative specimen collection kits provided by the Big Ten CRC Administrative Headquarters instead of supplies at my site?

It is very important for correlative specimen analysis that the collection of specimens for each clinical trial is standardized. The correlative managers at Big Ten CRC Administrative Headquarters provide all appropriate correlative specimen collection kits for each trial which include all items needed for the collection. This ensures all sites use the exact blood tube, cryovials, labels, etc. that are required for each protocol. It is important that sites do not use supplies from their own site. At any point in which kits are needed, a Kit Request Form found in each Study Procedures Manual may be completed and submitted to Big Ten CRC Administrative Headquarters.

Why is it important to enter accurate biospecimen data into the EDC system in a timely manner?

Just as the clinical data is highly important to understand the overall outcome of clinical trials, so too is the biospecimen data. Research staff at all participating sites must enter the biospecimen data into the EDC system according to the instructions provided in the Study Procedures Manual. Biospecimen data includes the date and time the specimens are collected, the quantity collected of each specimen, the date and time the specimens are processed, and when and where the specimens were shipped. This allows Administrative Headquarters staff to complete data entry by marking the specimens as being received by the corresponding laboratory and correcting any discrepancies that may exist between the biospecimen data entered into the EDC system and the data found on the specimen submission forms.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org.