The principal investigator (PI) submits any
reports of protocol deviations/violations to the Committee for the Protection
of Human Subjects (CPHS ), and this Policy/Procedure
describes the CPHS process for reviewing them.
Policy/Procedure
I.The deviation/violation report shall be submitted via the Internet
Research Information System (iRIS) no later than 10
working days after the Investigator first learns of the event.
A.The report of the protocol
deviation will be reviewed by the IRB coordinators to assess the significance
of the deviation per guidelines established by CPHS.
1.Those of substance or of serious consequence will be
brought to the attention of the CPHS chairperson (Chairperson) of the committee
at which the research was approved originally.
a)The Chairperson will review the deviation/violation
and determine if any further action is warranted.
(1)At the discretion of the Chairperson, serious or
significant deviations may be forwarded to the original subcommittee for
further review and/or included as discussion items on the committee agenda.
b)The Chairperson, subcommittee, or full committee
shall determine whether an appropriate plan of action is warranted to prevent
reoccurrence of the deviation and shall have the prerogative to approve and
require implementation of a remedial plan.
c)The Chairperson, subcommittee, or full committee
shall determine if the PI and/or research team shall be required to undergo
additional education on the conduct of research.
d)The Chairperson, subcommittee, or full committee may
request the Clinical Research Monitor conduct a monitoring review of the
research and of other research by the PI and/ or research team.
2.If the deviation is not of substance or serious
consequence it will remain in the iRIS system and
will not have further action.
B.All reported deviations
will be available in the iRIS system for continuing
review.