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Clinical Research Support

Clinical Research Unit (CRU)

Policies and Procedures

Policies and Procedures

DF/HCC is responsible for ensuring high quality human subject research across its member institutions. The DF/HCC standard operating procedures (SOPs) are documents that describe how particular functions are carried out. Listed below are links to the DF/HCC-wide SOPs and other important documents. These SOPs apply to investigators and research personnel involved in the conduct of cancer related human subject research at DF/HCC.

Regulatory Documents for Sponsors
Direct questions to the designated person listed below or to qact@partners.org.

DF/HCC SOPs for Human Subject Research
All SOPs are implemented prospectively from the effective date. If you need copies of old SOPs, please consult your institutional clinical trials office. Otherwise direct questions to cteo@dfci.harvard.edu or qact@partners.org.

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fold faq Acronyms


fold faq Glossary


fold faq Administration (ADM) SOPs
fold faq Audit (AUD) SOPs

fold faq Committee (COM) SOPs
fold faq Consent (CON) SOPs
fold faq Data Management (DATA) SOPs
fold faq Documentation (DOC) SOPs
fold faq Education & Training (EDU) SOPs
fold faq Investigational Product (INV) SOPs
fold faq Monitoring (MON) SOPs
fold faq Multi-Center Trial (MULTI) SOPs
fold faq Research Close Out (RCL) SOPs
fold faq Research Conduct (RCO) SOPs
fold faq Registration (REGIST) SOPs
fold faq Research Start-Up (RSU) SOPs
Draft SOP Documents
Policies that will go into effect on the indicated date.