February 2024 SOCRA Source Journal - Journal - Page 30
TABLE 4:
SUMMARY OF CLINICAL TRIALS REGISTRATION AND REPORTING REQUIREMENTS
Requirement
• NIH policy:Registration and results reporting
• FDAAA (Final Rule): Registration and results reporting
• ICMJE policy: Registration
Intervention type:
•
•
•
NIH policy: All (e.g., including behavioral, diagnostics, dietary supplement, etc.)
FDAAA (Final Rule): All FDA-regulated drugs, biologics and devices
ICMJE policy: All (e.g., including behavioral, diagnostics, dietary supplement, etc.)
Funding source:
• NIH policy: NIH
• FDAAA (Final Rule): Any
• ICMJE policy: Any
Phase:
• NIH policy: All
• FDAAA (Final Rule): Not phase I
• ICMJE policy: All
When to register:
• NIH policy: Not later than 21 days of enrollment of the first subject
• FDAAA (Final Rule): Not later than 21 days of enrollment of the first subject
• ICMJE policy: Prior to enrollment of the first subject
If non-compliant:
• NIH policy: Loss of NIH funding (to the principal investigator and/or the institution)
• FDAAA (Final Rule): Loss of Health and Human Services funding (to the study and/or the
institution), “Pre-notice” and/or “Notice of Noncompliance”, Civil monetary penalties (up to
$11,805 per day is the RECORD)
•
ICMJE policy: Rejected from publishing in ICMJE and other journals
results reporting system. Table
2 provides an overview of
the requirements for clinical
trial registration and results
reporting on ClinicalTrials.gov.
For an applicable clinical trial
(ACT), the responsible party
is responsible for registering
clinical trials and submitting
results. The responsible party is
30
defined as:
• “The sponsor of the clinical
trial, as defined in 21 CFR
50.3; or
• The principal investigator
(PI) of such clinical trial if so
designated by a sponsor,
grantee, contractor, or
awardee, so long as the PI is
responsible for conducting
the trial, has access to and
SOCRA SOURCE © May 2023
control over the data from
the clinical trial, has the right
to publish the results of the
trial, and has the ability to
meet all of the requirements
for the submission of clinical
trial information.”3
Under the General
Requirements of the Final
Rule3, the responsible party