Research Practice Guidelines

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Disclaimer: The research practice guidelines on this website are meant to serve as guidelines and are not intended, nor should they be considered to be policies of Boston Children's Hospital.

RPG-01 Research Staff Training 
This document is intended to provide guidance to clinical investigators and staff conducting clinical investigations for tracking and documenting research staff training and education.

RPG-02 Guidelines for Developing Case Report Forms (CRFs) 
This document is meant to serve as a standard for the development of CRFs by the Clinical Research Center (CRC) staff and a guide to assist investigators in developing well-designed CRFs.

RPG-03 Guidelines for Developing Randomization Procedures
This document describes the features of the Clinical Research Center randomization application and the procedures used by the Clinical Research Center staff to perform a randomization for a specific clinical trial.

RPG-04 Guidelines for Writing a Study Protocol
This document is intended to provide guidelines on the important scientific elements of a clinical research protocol. Guidelines are also provided for handling the collaborative processes and collegial issues that often arise in protocol development.

RPG-05 Guidelines for Developing a Manual of Operations (MOO) 
This document provides guidelines and advice to investigators and study staff regarding development of a study specific Manual of Operations.

RPG-06 Guidelines for Developing Surveys
These guidelines address the development of surveys and questionnaires by the Clinical Research Center (CRC) staff and a guide to assist investigators in developing well-designed surveys. They include planning for a survey project, developing survey instruments, pretesting a survey, and evaluating an instrument’s reliability and validity.

RPG-07 Guidelines for Data Collection
This document provides investigators and study staff with Clinical Research Center recommendations for ensuring high quality data in clinical research studies.

RPG-08 Guidelines for Data Handling
This document provides guidance to investigators in the procedures for storing and managing data and other documentation used for clinical research.

RPG-09 Guidelines for Recruitment
This document provides investigators and study staff with strategies for recruitment of subjects into clinical trials at Boston Children's Hospital.

RPG-10 Guidelines for Developing Pharmacy Procedures for Clinical Trials
This document outlines the general procedures for setting up and implementing the research pharmacy procedures for clinical research studies at Boston Children's Hospital.

RPG-11 Guidelines for Data and Safety Monitoring Plans/Boards (DSMP/DSMB)
This document describes guidelines for writing a Data and Safety Monitoring Plan (DSMP) and for formation of Data and Safety Monitoring Boards (DSMB).

RPG-12 Guidelines for Assuring Quality in Clinical Research
The purpose of this guideline is to assist investigators in developing and implementing procedures that will promote the conduct of high quality clinical research. Such quality control and assurance procedures provide a system of checks and examinations that help ensure the quality of clinical research studies.

RPG-13 Guidelines for Developing a Clinical Research Budget
The purpose of this document is to provide Investigators with guidelines for developing clinical research study budgets to ensure costs needed to properly conduct the research are considered.

RPG-14 Communicating and Reporting Statistical Analyses and Results
This document defines and clarifies CRC standards for interdisciplinary communication and reporting of statistical results. Because communication within a collaborative team is critical to the success of a clinical research project, the CRC maintains a vital interest in facilitating and providing guidelines for interacting with clinical collaborators.

The future of pediatrics will be forged by thinking differently, breaking paradigms and joining together in a shared vision of tackling the toughest challenges before us.”
- Sandra L. Fenwick, President and CEO
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