This form should only be used to report unanticipated problems involving risks to subjects or others (hereafter known as unanticipated problems) and investigator- or sponsor-initiated study suspensions or holds. Do not use this form to report non-compliance.
Progress Reports
|
Study Type |
Reporting
Schedule |
|
Clinical Trials |
Comprehensive
progress report every 6 months, regardless of study stage (no submission fees
required) |
|
Other Studies |
At the time of
continuing review / renewal (generally annually, unless otherwise specified
by ISERC or required by initial approval conditions) |
Categories of Adverse Events
AE Category
|
Reporting
Deadline |
|
Unanticipated,
life-threatening, or fatal SAEs |
Immediately or
within 24 hours of the investigator becoming aware |
|
Other
unanticipated SAEs |
Within 7–10
days to MTRH/MU-ISERC |
|
Non-serious but
related adverse events |
Summary or
periodic report at continuing review, alongside deviation/violation reports |
Protocol Deviations and Violations
|
Type |
Definition |
Action
Required |
|
Protocol
Deviation |
Minor or unintentional
departure from the approved protocol that does not significantly affect
participant safety, rights, or data integrity (e.g., missed study visit, late
lab test) |
Report in
periodic/continuing review submission |
|
Protocol
Violation |
Significant
breach that could compromise participant safety, rights, or scientific
validity (e.g., enrolling ineligible participants, failure to obtain informed
consent, wrong study drug dose) |
Immediate
reporting to MTRH/MU-ISERC; corrective action may be required |