Regulatory File Set Up - Dana-Farber/Harvard Cancer Center

DANA-FARBER / HARVARD CANCER CENTER
STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH
TITLE: GCP Training Requirement for New Researchers
SOP #: ET-205 Page: 1 of 2
Applicable Regulations
& Guidelines:
Other References:
Responsible Personnel:
Policy Statement:
CTEO website
New Researchers, CTEO, QACT, OHRS, Clinical Trials
Committee Chairs, Clinical Trial Offices
New researchers are required to complete the DF/HCC
Investigator Good Clinical Practice (GCP) Training course
prior to their involvement in human subject research.
Researchers must complete this course regardless of
whether or not they have completed GCP training at
another institution.
Definition:
New Researchers: Physicians, Site Responsible PIs, or Collaborating
Investigators who are assuming human subject research responsibilities
for the first time on a trial being conducted at DF/HCC. This includes
both:
1. Researchers without prior research experience
2. Researchers coming to DF/HCC from external institutions
Procedure:
Please note: This policy applies to clinical and non-clinical researchers.
1) Program leaders and/or Clinical Trial Offices will apprise new researchers of
the requirement to complete the DF/HCC Investigator Good Clinical Practice
(GCP) Training course. Proactive completion of the course prior to being listed
on a DF/HCC protocol will be encouraged.
2) New researchers must contact the CTEO to register for the online GCP course.
Once researchers are registered, they only need to enter their username and
password to access the training site.
a. The training site is accessible from the CTEO website. Click on Education
which is located on the right navigation bar. Next, look for the section on
Investigator Education.
3) To prevent delays in protocol participation, QACT and CTEO staff will
screen all newly submitted protocols and amendments for new DF/HCC
researchers; and confirm the GCP training requirement has been met.

TITLE: GCP Training Requirement for New Researchers
SOP #: ET-205 Page: 2 of 2
4) If a new researcher listed on a protocol has not completed training, the Overall PI
will be informed of this requirement as part of the QACT comments submitted at
the time of SRC and/or IRB review. The new researcher must complete the
training in order to remain on the protocol, or his or her name will be removed at
the time of protocol activation. CTEO will inform OHRS when the new
researcher has met the training requirement. If a name is removed it may be
added in the form of an amendment at a later date, after GCP training is
completed.
Original Approval Date: 3/2/10
Revision Dates:
Effective Date: 8/2/10