Other Not Including Serious Adverse Events Template
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Summary
More details available in the Results Data Element Definitions. April 2017Other (Not Including Serious) Adverse Events Template ClinicalTrials.gov *§ Time Frame [*] Adverse Event Reporting Description Source Vocabulary Name for Table Default ① *§ Collection Approach for Table Default ① (Select One) Systematic Non-Systematic * Arm/Group Title *§ Arm/Group Description ② * Other (Not Including Serious) Adverse Events * Frequency Threshold for * Number * Number * Number * Number * Number * Number Reporting Other Adverse Participants Participants Number Participants Participants Number Participants Participants Number Events (0–5%) _____% Affected at Risk Events Affected at Risk Events Affected at Risk Events * Total * Adverse Event * Organ System Term ③ ④[*] ④[*] ④[*] ③ ④[*] ④[*] ④[*] ③ ④[*] ④[*] ④[*] ③ ④[*] ④[*] ④[*] ③ ④[*] ④[*] ④[*] ③ ④[*] ④[*] ④[*] ③ ④[*] ④[*] ④[*] ③ ④[*] ④[*] ④[*] * Required *§ Required if Primary Completion Date is on or after January 18, 2017 [*] Conditionally required ① If entered, the table default values apply to all Adverse Event Terms. The values may be changed for any single Adverse Event, if different from the table default
② Arm/Group Description describes details about the intervention strategy (e.g., dose, dosage form, frequency, duration) or groups evaluated
③ Organ System must be selected from a pick-list of high-level categories. See the Results Data Element Definitions for details
④ Number of Participants at Risk for an Adverse Event Term is only required when the value differs from the Total Number of Participants at Risk
The values may be changed for any single Adverse Event, if different from the table default. ② Arm/Group Description describes details about the intervention strategy (e.g., dose, dosage …
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Frequently Asked Questions
What is a serious adverse event?
What is a Serious Adverse Event? An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is: Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
Why are adverse events evaluated in clinical trials?
One of the reasons that a research molecule undergoes through different phases of clinical trials is to establish the safety and efficacy of the drug. To establish the safety profile of any drug, the most important aspect is to evaluate every adverse event (AE) that a clinical trial individual experiences.
What is an adverse event in medical coding?
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is: Death. Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
What is considered a life threatening adverse event?
An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of the investigator, its occurrence places the patient or subject at immediate risk of death. It does not include an adverse event or suspected adverse reaction that, had it occurred in a more severe form, might have caused death.