Safety Monitoring
All participants involved in the study are monitored by
licensed doctors of chiropractic serving as research clinicians.
Research clinicians routinely evaluate participants
for status change by probing for adverse events and performing
clinical evaluations at each visit throughout the
study period.
Adverse Events
We monitor safety at two levels: 1) adverse events (AE)
that are possibly, probably, or definitely related to the
practice of spinal manipulation and 2) serious adverse
events (SAE) regardless of their attribution. For this
study, we define an AE as any untoward medical occurrence
that may present itself during the conduct of the
study and which may or may not have a causal relationship
with the study procedures. The Adverse Event
Grading and Reporting Protocol defines when and how
these events are reported to the DSMC and the IRB.
Clinicians assess whether an AE is: 1) mild, moderate,
severe, or serious; 2) expected (disclosed in the Consent
Form or part of an underlying disease) or unexpected
(more serious than expected, or not disclosed in the
Consent Form); and 3) definitely related to intervention,
probably related, possibly related, unlikely related or
unrelated.
We use the FDA definition of SAE, which is any
adverse experience occurring during treatment that
results in any of the following outcomes: death, a lifethreatening
adverse experience, hospitalization or prolongation
of existing hospitalization, a persistent or significant
disability/incapacity, or a congenital anomaly/
birth defect resulting from a pregnancy (21CFR314.80,
revised 01 April 2010). AE information is collected during
the treatment encounters and at all follow-up assessments.
Participants also are instructed to contact
investigators in the event of clinically important pain,
discomfort or distress that they believe may be associated
with treatment. We developed an automated
web-based system for recording and monitoring all AE’s
that are possibly, probably or definitely related to study
participation and all SAE’s. The clinical team recordsunrelated and unlikely related AE’s and reports these
events to the IRB and DSMC quarterly. The project
managers and senior clinician are responsible for tracking
and reporting all adverse events to the principal
investigator. The Adverse Event Grading and Reporting
Protocol determines when and how these events are
reported to the DSMC and the IRB when appropriate
Safety MonitoringAll participants involved in the study are monitored bylicensed doctors of chiropractic serving as research clinicians.Research clinicians routinely evaluate participantsfor status change by probing for adverse events and performingclinical evaluations at each visit throughout thestudy period.Adverse EventsWe monitor safety at two levels: 1) adverse events (AE)that are possibly, probably, or definitely related to thepractice of spinal manipulation and 2) serious adverseevents (SAE) regardless of their attribution. For thisstudy, we define an AE as any untoward medical occurrencethat may present itself during the conduct of thestudy and which may or may not have a causal relationshipwith the study procedures. The Adverse EventGrading and Reporting Protocol defines when and howthese events are reported to the DSMC and the IRB.Clinicians assess whether an AE is: 1) mild, moderate,severe, or serious; 2) expected (disclosed in the ConsentForm or part of an underlying disease) or unexpected(more serious than expected, or not disclosed in theConsent Form); and 3) definitely related to intervention,probably related, possibly related, unlikely related orunrelated.We use the FDA definition of SAE, which is anyadverse experience occurring during treatment thatresults in any of the following outcomes: death, a lifethreateningadverse experience, hospitalization or prolongationof existing hospitalization, a persistent or significantdisability/incapacity, or a congenital anomaly/birth defect resulting from a pregnancy (21CFR314.80,revised 01 April 2010). AE information is collected duringthe treatment encounters and at all follow-up assessments.Participants also are instructed to contactinvestigators in the event of clinically important pain,discomfort or distress that they believe may be associatedwith treatment. We developed an automatedweb-based system for recording and monitoring all AE’sthat are possibly, probably or definitely related to studyparticipation and all SAE’s. The clinical team recordsunrelated and unlikely related AE’s and reports theseevents to the IRB and DSMC quarterly. The projectmanagers and senior clinician are responsible for trackingand reporting all adverse events to the principalinvestigator. The Adverse Event Grading and ReportingProtocol determines when and how these events arereported to the DSMC and the IRB when appropriate
การแปล กรุณารอสักครู่..