February 2024 SOCRA Source Journal - Journal - Page 32
trials on ClinicalTrials.gov.9
ICMJE requires registration of
any human research project that
prospectively assigns human
subjects to intervention or
comparison groups to study the
cause-and-effect relationship
between a medical intervention
and a health outcome.10
Medicare requires registration
for all Medicare qualifying trials,
including some Phase 1 and
device feasibility trials, in order
to receive reimbursement. This
was effective as of January 1,
2015. National Clinical Trial
(NCT) numbers are required
on clinical research-related
claims in order to receive
payment. Patients should not
be enrolled in a trial unless
the NCT registration number
is in place.11 The Final Rule
and the NIH policy require the
initial registration within 21
days of the enrollment of the
first participant. ICMJE policy,
however, requires registration
before the enrollment of the
first participant.
Table 4 provides the summary
of Clinical Trials Registration
and Reporting Requirements.
For clinical trials initiated on or
after January 18, 2017, the Final
Rule requires updating the study
status and other information
on ClinicalTrials.gov at least
every 12 months. If a protocol is
amended in such a manner that
changes are communicated to
human subjects in the clinical
trial, however, updates to
ClinicalTrials.gov must be made
within 30 calendar days after
the protocol amendment is
approved by a human subjects
protection review board.
Some of the following critical
32
data elements must be updated
within 30 calendar days, as per
the Final Rule12:
• Study Start Date
• Overall Recruitment Status
• Individual Site Status
• Human Subjects Protection
Review Board Status
• Primary Completion Date
• Study Completion Date
• Responsible Party Changes.
The record verification date
must be updated any time
the responsible party reviews
the complete set of submitted
clinical trial information for
accuracy and not less than
every 12 months, even if no
other updated information is
submitted at that time.12
Sometimes, the ClinicalTrials.
gov protocol registration
and results reporting
system team will send the
responsible party queries about
errors, deficiencies, and/or
inconsistencies in the clinical
trial registration or results
reporting. The responsible party
must answer registration queries
within 15 calendar days and
results reporting queries within
25 calendar days.
In order to determine when
results for interventional and
observational studies must be
reported on ClinicalTrials.gov, it
is necessary to know the primary
completion date and the study
completion date.12
The primary completion date is:
“The date that the final
participant was examined or
received an intervention for the
purposes of final collection of
data for the primary outcome,
whether the clinical study
concluded according to the
SOCRA SOURCE © May 2023
pre-specified protocol or was
terminated.”
In the case of clinical studies
with more than one primary
outcome measure with different
completion dates, this term
refers to the date on which data
collection is completed for all of
the primary outcomes. Once the
clinical study has reached the
primary completion date, the
responsible party must update
the Primary Completion Date
to reflect the actual primary
completion date.”12
The study completion date is:
“The date the final participant
was examined or received an
intervention for purposes of
final collection of data for the
primary and secondary outcome
measures and adverse events
(for example, last participant’s
last visit), whether the clinical
study concluded according
to the pre-specified protocol
or was terminated. Once the
clinical study has reached the
study completion date, the
responsible party must update
the Study Completion Date
to reflect the actual study
completion date.”13
One year after the primary
completion date, submission
of primary outcomes data
is required. Once the study
completion date is reached,
submission of secondary
outcomes data is required. The
primary completion date is not
the date that the data were
analyzed. It is the date the study
was closed.
Compliance with the
requirements for clinical
trial registration and results
submission on ClinicalTrials.gov