April 1, 2016:

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

What electronic data capture system (EDC) does Big Ten CRC Administrative Headquarters use for clinical trials?

The Big Ten CRC Administrative Headquarters uses OnCore Enterprise Research Electronic Data Capture Module (EDC), a product of Forte Research Systems. EDC is part of the larger OnCore Enterprise Research System that allows for protocol, subject, and data management in one centralized place. OnCore’s EDC provides the following key features:

  • Flexible forms design that can accommodate the wide variety of data captured during Oncology Clinical Trials.
  • A variety of built in or configurable validation checks and constraints to ensure data quality and consistency.
  • A range of data management tools and powerful reporting capabilities.

Does the OnCore EDC system allow for collection of biospecimens?

The EDC system does allow for the collection of biospecimen data. The Biospecimen Collection Console within the EDC system allows clinical research staff to log several data fields pertaining to biospecimens. These may include:

  • Type of Biospecimen (serum, plasma, whole blood, etc.)
  • Time Point of Collection (C1D1, End of Treatment, etc.)
  • Quantity (mLs, number of slides, etc.)
  • Barcode Number (each biospecimen is given a unique barcode number for tracking)
  • Collection Date and Time
  • Preparation Date and Time (time biospecimens were frozen, slides were cut, etc.)
  • Comments (any relevant comments pertaining to the biospecimens)
  • Destination (where biospecimens are being shipped for analysis/storage)
  • Shipped Date (Date biospecimens were shipped)
  • Received Date (Date biospecimens were received at receiving Lab)

How are protocols developed in the EDC system?

The Big Ten CRC Administrative Headquarters data team works collaboratively with the Sponsor-Investigator to develop complete, concise databases to capture the necessary data to meet study objectives.

  • Database development begins once a protocol has completed scientific review and received approval at the lead site.
  • A draft of the study eCRFs and calendar is presented to the Sponsor-Investigator for initial feedback and review for missing or unnecessary data points.
  • The Clinical Data Manager (CDM) and Clinical System Developer (CSD) at the Big Ten CRC Administrative Headquarters perform extensive testing of the eCRFs and Calendars for each study to ensure the database is complete and functional.
  • The final database is reviewed and signed-off by the Sponsor-Investigator prior to the study being opened for accrual.

How do sites gain access to the EDC system?

The Big Ten CRC access process requires the following steps:

  • 1. Request: Site staff may request access to OnCore during the Site Initiation Visit (SIV) or by contacting any HCRN Staff.
  • 2. Authentication: All access requests must be authenticated by authorized site staff before access may be granted.
  • 3. Training: All site staff must receive protocol-specific training before access will be granted. When an access request form is received the assigned CDM for the trial will schedule a training session with the site staff.
  • 4. Confirmation: Site staff will receive a training confirmation form at the conclusion of the training session. Once this form has been submitted access can be granted.
  • 5. Site staff will receive an introductory guide with instructions for accessing the OnCore system. This documentation also provides helpful tips for using OnCore.

What is data validation?

Data Validation is a piece of the Clinical Data Management process. Data validation involves data collection, data review to ensure high-quality data, and managing subject data in compliance with regulatory standards. High-quality data is defined by Accuracy, Integrity, Completeness, Validity, Consistency, Uniformity, Density, and Uniqueness. The Clinical Data Manager will ensure data meets the quality criteria to result in accurate and consistent data that meet the study objectives for reporting to regulatory bodies.

How is data prepared for analysis?

Following thorough data validation, data collected through the OnCore CTMS and stored in the OnCore database is prepared for analysis with the following steps:

  • Oracle views are created for all data collected in forms and through tabs in OnCore.
  • SAS datasets are created from Oracle views.
  • Raw data are stored in SAS data management datasets to create a snapshot of the data.
  • Data management datasets are processed into SAS statistical analysis datasets.
  • Statistical analysis datasets are checked for duplicates, missing data and other quality characteristics.
  • A clinical trial endpoint dataset is created to analyze the primary objective.
  • Correlative datasets are converted to SAS format, processed and added to the statistical analysis datasets.
  • Other datasets are converted to SAS format, processed and added to the statistical analysis datasets (e.g. dietary diaries).
  • The full collection of statistical analysis datasets are released to the statistician with data dictionaries.

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.