Clinical Research Support
Clinical Trials Education Office (CTEO)
Workshops
These workshops were designed to help new research staff better understand their roles and responsibilities, general guidance and information for conducting clinical trials through the Dana-Farber/Harvard Cancer Center.
Registration* for the workshops is required and can be done by accessing the on-line registration form located at the end of each workshop description. Questions regarding the workshops should be sent to Clinical Trials Education Office (CTEO@dfci.harvard.edu).
Support and Guidance for Clinical Trials
Representatives from the Quality Assurance Office for Clinical Trials (QACT), Research Pharmacy, Research Nursing, Biostatistics Core and Clinical Trials Education Office (CTEO) provide a review of their roles in the research conducted at DF/HCC. Topics such as protocol development, drug procurement, patient recruitment, inservices, registration, auditing and monitoring will be covered in this hour and a half session.
Upcoming Course Date:
Thursday October 2nd 10am-11:30am Smith 308 Register
IRB Process
This workshop focuses on the human subject review process and pertinent federal regulations. New research staff members unfamiliar with the IRB review process and federal regulations pertaining to clinical research and veteran research staff looking to refresh their knowledge of the submission process and IRB review are welcome to attend.
Upcoming Course Date:
Thursday October 16th 10am-11am Smith 308 Register
IRB Forms: A Hands on Approach
This workshop focuses on the completion of Post-Activation forms. Learn what form to submit, when to submit them, how to fill them out accurately, and what information should accompany them. Anyone involved in submitting forms to the IRB is encouraged to attend.
Upcoming Course Date:
Thursday October 30th 10am-11:30am Smith 308 Register
Thursday Novembe 6th 10am-11:30am Smith 308 Register
Roles and Responsibilities: Protocol Management
This workshop focuses on a study coordinator's responsibilities when it comes to protocol management. Topics include understanding a protocol, deviations/violations, pre-study activities, study initiation meetings and subject enrollment. New research staff are stongly encouraged to attend this informative session.
Upcoming Course Date:
Thursday November 13th 10am-11:30am Smith 308 Register
Thursday November 20th 10am-11:30am Smith 308 Register
Roles and Responsibilities: Document and Data Management
This workshop focuses on a study coordinator's responsibilities when it comes to data management. Topics include source documents, regulatory binders, research files and case report forms.
Upcoming Course Date:
Thursday September 4th 10:00am-11:00am Smith 308 Register
Thursday September 11th 10am-11:00am Smith 308 Register
Roles and Responsibilities: Adverse Event Reporting
This is an in-depth review of adverse events including definitions, determinations and reporting requirements for serious adverse events. This workshop gives a lot of real life examples including searching the CTCAE for correct terminology and the DF/HCC reporting guidelines.
Upcoming Course Date:
Thursday October 9th 10am-11:30am Smith 308 Register
Thursday October 30th 10am-11:30am Smith 308 Register
*Registration is limited to 15 people per session*
