ARTOSS Foot and Ankle Registry (ARK)
Form 3 - Surgical complications and adverse events
Patient Registry Number (enter text) *
Adverse Event Definition: “Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).
If an adverse event as described above has been recorded in the patient’s chart call the Director of Regulatory and Clinical Affairs, Artoss Inc. at 813-545-9361.
Surgical Complication (occurs during surgery or before discharge, describe, enter text)
Causality Catagories:
• Certain: a clinical event, including laboratory test abnormality, occurring in a plausible time relationship to drug administration, and which cannot be explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the drug (dechallenge) should be clinically plausible. The event must be definitive pharmacologically or phenomenologically, using a satisfactory rechallenge procedure if necessary.
• Probable/Likely: a clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal (dechallenge). Rechallenge information is not required to fulfil this definition.
• Possible: a clinical event, including laboratory test abnormality, with a reasonable time sequence to administrations of the drug, but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.
• Unlikely: a clinical event, including laboratory test abnormality, with a temporal relationship to drug administration which makes a causal relationship improbable, and in which other drugs, chemicals or underlying disease provide plausible explanations.
• Conditional/Unclassified: a clinical event, including laboratory test abnormality, reported as an adverse reaction, about which more data is essential for a proper assessment, or the additional data is under examination.Unassessable/Unclassifiable: a report suggesting an adverse reaction which cannot be judged because information is insufficient or contradictory, and which cannot be supplemented or verified.
Relation to NanoBone
Treatment (describe, enter text)
Reportable?
Resolved? *
Adverse Event (occurs after discharge during follow-up period, describe, enter text)
Days From Surgery (enter text)
Relation to NanoBone
Reportable?
Resolved? *
Notes:
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