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Clinical Research Operations | Overview

The clinical research professionals of the Clinical Research Operations Center provide exceptional support and service to investigators conducting clinical research studies at Boston Children’s Hospital. The Center supports a full spectrum of studies from high-risk interventional trials with experimental therapeutics, and experimental drugs and devices, to the minimal-risk observational clinical research studies. The Center provides exceptional service in the following areas:

  • protocol development
  • project management for planning and implementation of studies
  • case report form creation
  • coordination of database builds
  • recruitment and retention of research subjects
  • administration of surveys, interviews and study tracking
  • biospecimen collection and tracking
  • medical record abstraction, data entry and reports
  • study close out activities management of multi-institutional clinical trials
  • single patient INDs
  • support for FDA-regulated trials
  • development of data safety monitoring plans and data safety monitoring boards or committees
  • facilitating collaborative partnerships among key institutional resources that support clinical research
  • foster collaborative relationships between clinical trialists and basic/translational researchers
  • support for grant applications and publication submissions
  • medical writing
  • scientific review
  • support for consortium work

For more information or to request assistance, contact Cindy Williams, DNP, RN, PNP, NE-BC.

Clinical Research Operations Center scientific review

The Clinical Research Operations Center provides an optional scientific review with the goal of strengthening the scientific rigor and study design of investigator-initiated clinical research studies. The scientific review process is also intended to expedite the IRB review process by anticipating and addressing protocol issues that stand to be raised during the IRB review. The Center’s Scientific Review Committee is an interdisciplinary team of experienced investigators, biostatisticians, research nurses, regulatory experts and other clinical research professionals with experience in conducting various types of clinical research studies. Feedback is provided to the investigator within 14 days of submission of the protocol.

There is no requirement or expectation to address or change the protocol based on the reviewers’ comments. Nor do investigators respond to the committee’s reviews. The feedback/comments are strictly for the investigator’s consideration. The review is confidential and intended as a service to the Boston Children’s clinical research community. There is no charge associated with the review.

To further discuss scientific review for your protocol, please contact Leah Cheng.

Waltham satellite location

The Clinical Research Operations Center also can provide support to study teams conducting clinical research in the Boston Children’s Waltham satellite location.  Learn more >> .