Clinical Research Support
The Clinical Trials PROTOCOL LIFECYCLE highlights the 8 key steps from creation to completion of a clinical trial at DF/HCC. Click through the steps below for more information, and refer to the left-side menu for policies, guidances, forms, templates, and other resources.
Step 1
Researchers interested in conducting cancer related human subject research at any of the five DF/HCC academic medical centers (Boston Children’s Hospital, Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, and Massachusetts General Hospital) are required to follow DF/HCC Standard Operating Procedures (SOPs) and use DF/HCC protocol templates when creating new proposals.
Step 2
Once a new DF/HCC protocol has been created, it must be submitted to the Office for Human Research Studies (OHRS) before research can begin. New protocol submission types include Clinical Trials Research, Social and Behavioral Research, Retrospective Medical Records Review, Prospective Collection of Human Material or Data, Request for an Exemption Determination, or Request for a Determination of Not Human Subjects Research. Submissions to OHRS require researchers to have access to: OHRS Submit, OnCore and OncPro systems.
Step 3
The Office for Human Research Studies (OHRS) manages the submission and review of all new DF/HCC protocol submissions. Scientific Review is a requirement of the DF/HCC Cancer Center Support Grant (CCSG) and is conducted by the Scientific Review Committees (SRC). The Institutional Review Boards (IRB) review and approve all new DF/HCC research prior to study activation.
Step 4
The Office for Human Research Studies (OHRS) manages the activation of new DF/HCC protocol submissions. After approval from the Scientific Review Committees (SRC) and Institutional Review Boards (IRB), and before the research can begin, OHRS routes the research for Activation Sign off by key departments responsible for conducting the research. The process ensures that all departments involved in the research from each participating site, including Pharmacy, Nursing, Pathology, and Research Administration, are fully prepared to conduct the research.
Step 5
Conduct of all DF/HCC clinical trials must follow all DF/HCC Standard Operating Procedures (SOPs). The Office of Human Research Studies (OHRS) and Quality Assurance for Clinical Trials (QACT) have created numerous Guidances and Information Sheets to assist researchers in the management of their studies. QACT also offers data management services for PI-initiated studies. Serious Adverse Event Reporting and Continuing Review requirements are essential elements of trial conduct. The Clinical Operations Committee (CLINOPS) provides a forum for research management at the DF/HCC member institutions.
Step 6
Oversight of research at DF/HCC is managed by the DF/HCC Clinical Research Committee (CLC), the Quality Assurance Office for Clinical Trials (QACT), and the Office for Human Research Studies (OHRS). Oversight activities include internal auditing and monitoring, review by the Data and Safety Monitoring Committee (DSMC) and Data and Safety Monitoring Board (DSMB).
Step 7
DF/HCC provides resources for investigators to assist with publication of their research results. Resources include data analysis, biostatistician support, and publication tools.
Step 8
When the results from a DF/HCC research have been published and no further research will ensue, the research must be formally closed out following DF/HCC Standard Operating Procedures (SOPs). The Office for Human Research Studies (OHRS) must be notified of the study completion and all materials related to the study must be securely maintained after the research concludes.