The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final document on its SG5:N5:2012 clinical trials adverse event reporting standard.
The standard, Reportable Events During Pre-Market Clinical Investigations, released 10 August 2012, is the product of GHTF's Study Group 5 (SG5)-a group charged with harmonizing clinical safety and performance standards for medical devices.
GHTF explains in the standard that pre-market clinical trials present unique safety problems for investigators, and should be held to even higher standards than post-market adverse event reporting because the devices have likely not yet been shown to be safe in humans. Advanced and expeditious identification of safety signals is necessary to alter the product's instructions for use, make changes to the clinical investigation plan or stop testing entirely.
Reporting Timelines and Content
The standard defines a number of terms, including subject, use error, adverse events, unanticipated serious adverse device effect, sponsor, serious health threat, serious adverse event, investigator, principal investigator, comparator, device deficiency, clinical investigation plan and adverse device effect.
All adverse events defined as being "serious" in nature are required to be reported to the National Competent Authority (NCA), as well as "device deficiencies" that could have resulted in a serious adverse event were it not for an intervening and fortunate circumstance. Since the latter is open to some degree of subjective interpretation, GHTF advises sponsors to make, "reasonable efforts to obtain additional information," adding that sponsors should err on the side of reporting such incidences.
GHTF's document also sets a series of reporting timelines that sponsors of pre-market clinical trials would be required to use. For serious health threats, defined as being a risk to a large population of trial enrollees, the NCA must be notified within 48 hours of being made aware of the threat. Serious and unanticipated adverse events must be reported to NCAs within 10 calendar days of the reporting party being made aware of the existence of a safety issue, while all other events are reportable within 30 calendar days.
Information required to be reported to NCAs for each report is detailed in GHTF's document, and includes information about the sponsor, the adverse event, the device, the trial, the patient and an assessment of the event.
The standard comes just days after the release of a GHTF guidance on transferring adverse event data between manufacturers, authorized representatives and National Competent Authorities. That document seeks to move adverse event reporting to an extensible markup language (XML)-based electronic reporting standard capable of being used by multiple stakeholders with different needs.
It is unclear whether the US Food and Drug Administration or other global regulatory bodies will act on the document after leaving GHTF in late 2011 to form the IMDRF. GHTF's transition to an industry-only body leaves its current standards in a state of limbo, with the potential to be adopted by IMDRF but lacking any guarantees.