The Clinical Research Center Research Practice Manual Guideline for Writing a Study Protocol – RPG-04 Guideline Purpose

Developing protocols for clinical research in collaboration with investigators at Boston Children‘s Hospital is one of the primary activities mandated by the mission of the Clinical Research Center (CRC). The written protocol is the embodiment of a clinical research plan and expresses its scientific agenda, clinical relevance, organizational thoroughness, and professional quality. A crucial interest of CRC is therefore to ensure that protocols developed under its auspices follow a high standard of scientific merit and methodological content. An additional aim of equal importance is that a protocol be clear and comprehensible to the variety of audiences that it addresses, including medical, statistical, and human-subjects reviewers as well as the co-investigators and staff who are ultimately charged with carrying out the research. A comprehensive, readily available Standard Operating Procedure for protocol development, comprising outlines, guidelines, templates, ‗boilerplates, ‘ comments, and examples, should enable, by its regular use, CRC staff to attain and maintain high standards in performing this central task, particularly when collaborating with inexperienced medical investigators. The intent of this document is to furnish the reader with guidelines on the important scientific elements of a clinical research protocol; to describe their essential content and interrelationships; to indicate which elements are optional and which mandatory; and to illustrate their key features with examples. Guidelines will also be provided for handling the collaborative processes and collegial issues that often arise in protocol development. All investigators should follow the specific instructions provided by the CHB Committee on Clinical Investigation (CCI) when submitting a protocol for IRB approval, particularly regarding requirements for human subjects protection. Information and guidelines from CCI can be found on the hospital intranet unde