March 4, 2016:

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

Monitoring staff at Big Ten CRC Administrative Headquarters will perform risk-based monitoring as outlined in our Data Monitoring Plans. Site monitoring is an essential part of the Big Ten CRC’s ability to successfully run trials. Monitoring staff will source verify critical data elements in the patient charts to what is entered into the OnCore database. Critical data is identified as data supporting the primary and secondary objectives (e.g., eligibility, treatment data, disease evaluations, adverse events, serious adverse events, specified tests, etc.).

How does a Big Ten CRC monitor prepare for a visit?

  • The monitor will contact the site with a personal phone call on first contact with the site, and will re-confirm by email to schedule the first site visit after the first patient is accrued at site for the study.
  • The monitor will ask the site for special traffic, parking, and lodging instructions. This information will help the monitor prepare for road construction, traffic delays, and alternate routes when needed.
  • Once a visit is scheduled, the monitor will send a confirmation letter to the site outlining the visit. This information will include the study being monitored, the records that will need to be available for the patient(s) to be source verified, who should be present (the PI should know who we are), details regarding a pharmacy visit, a reminder that all data should be current in the database, and the arrival time for the visit.

What is the timing of a Big Ten CRC monitoring visit?

The first monitoring visit is usually scheduled once a patient has received at least two cycles of treatment. After the first visit, the timing depends on accruals. Each site should expect to see a Big Ten CRC monitor once or twice in an 18-month period.

What types of monitoring visits does the Big Ten CRC perform?

  • Site Verification visits: The monitor will verify investigative sites and associated principal investigators for clinical trial participation in Big Ten CRC studies.
  • Initial visit: This visit will consist of monitoring the first patient on a trial at the site. If this is a first visit to a site, the monitor may ask for a tour and the opportunity to meet the staff and visit with the PI.
  • Follow-up visits: The monitor will perform routine follow-up monitoring visits to complete the monitoring on studies and patients previously monitored and any new patients as outlined in the Data Monitoring Plan.

What should a site expect during a Big Ten CRC monitoring visit?

  • Provide a space for the monitor to work for the duration of the visit. The site contact will show the monitor to the space, and the monitor will proceed to set up a laptop and tools needed to source verify.
  • Provide access to electronic medical records and/or paper chart(s). Prior to the visit, please secure a working login and password for the monitor.
  • Provide Internet access or information regarding any firewall issues or if we will need to provide a hotspot.
  • Ensure consent, baseline, eligibility, screening, randomization, and at least two cycles of treatment have been entered into the database.
  • The monitor will spend a few minutes discussing expectations and documentation requirements up front, explaining the monitoring plan, timing of visits, data clarifications and how these will be resolved, and that time will be used near the end of the visit to address queries, clarifications, training issues, and any questions.
  • The monitor will ask that clarifications not resolved during the visit be sent to the monitor within a week.

What is the site pharmacy monitoring process?

The goal of the site pharmacy monitoring process is to provide accurate storage of study drug, drug dispensing log, inventory, and destruction log.

Once the monitoring visit has been scheduled, the monitor will determine if a pharmacy visit is required. If a pharmacy visit is required, the monitor and the site will determine whether the coordinator will schedule the pharmacy visit or if monitor should contact the pharmacy to schedule the visit. This practice varies from site to site.

Pharmacy review will include:

  • Pharmacy security: Locked pharmacy and adequate security.
  • Storage of drug: Information is available in the full protocol.
  • Dispensing log: Random check for dispensing of study medication based on date and
    dose of drug.
  • Inventory: Inventory matches the dispensing log.

What should I expect after a monitoring visit?

  • You will receive a survey from Big Ten CRC Administrative Headquarters for your feedback regarding the visit. This is a very short survey that will help us improve our monitoring processes.
  • The monitor will send a follow-up letter to the PI, project manager, and any site contacts who request a copy.
  • The monitor will review accruals at each site during the course of the study and will contact sites for follow-up visits.

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