Participants safety and Adverse events?

When an AE is labeled "associated with the use of the intervention" it means that...

there is a reasonable possibility that the AE may have been caused by the intervention and is meant to convey in general that there are facts (evidence) or arguments to suggest a causal relationship.

What is a serious adverse event?

An AE is considered serious if it poses a threat to the patient's life or functioning.

What is an adverse event?

An AE may be "any unfavorable or unintended" sign, symptom, or disease that occurs in a person who has taken medication. The occurrence does not need to be related to the drug/ device treatment. An adverse event (AE) may be: A physical event (e.g., a rash). A psychological event (e.g., depressed mood). A laboratory event (e.g., elevated blood sugar). An increase in the severity or frequency of a pre-existing symptom or condition (e.g., increased pain in a painful tooth) An adverse event may also be referred to as an "adverse experience."

For clinical studies in which investigational new drugs are used, the FDA defines an unexpected AE as:

An AE that is not consistent with the information about the drug's risks that appears in the relevant source document(s) (e.g., protocol, Investigator's Brochure, and consent documents), or An AE that is not consistent with the risk information, or An AE that has occurred within the class of drugs, but not specifically with the Investigational Product.

For clinical studies related to the use of marketed drugs, the FDA defines an unexpected Adverse event as

An AE that is not listed in the drug's current labeling, or An AE that is more severe or more specific than indicated in the labeling.

Relatedness when referring to an AE means

A causal relationship means that the intervention caused (or is reasonably likely to have caused) the AE. This usually implies a relationship in time between the intervention and the AE (e.g., the AE occurred shortly after the participant received the intervention).

Situations involving the use of a drug in humans in which an adverse event may occur

A drug overdose, whether accidental (e.g., the patient is of a small size or has poor metabolism of the drug) or intentional (e.g., suicide attempt). An interaction with food or with another medication. Drug abuse (e.g., the patient faints when taking a nonprescribed drug to "get high"). Drug withdrawal (e.g., the patient stops taking a prescribed medication and has a seizure). Any failure of expected pharmacological action (e.g., a drug given to slow a patient's heart rate instead increases the heart rate). The use of a drug in professional practice (e.g., when an approved [marketed] drug is given to a patient and he or she develops a rash). The patient does not need to be enrolled in a clinical trial.

A 15 year old male has come in for a site visit. The participant was randomized to product Z for treatment of severe cystic acne. The participant's parents report that after several weeks on the treatment the participant had mood swings, was crying, said he was "feeling blue" and attempted suicide. The participant discontinued the drug. Is this a reportable event(s)? A. Yes B. No

A) Correct, (A) is the best answer. Suicide attempt is a reportable event.

IS THIS AN ADVERSE EVENT (AE) OR A SERIOUS ADVERSE EVENT (SAE)? Scenario Severe cramps in arms and legs.

AE

IS THIS AN ADVERSE EVENT (AE) OR A SERIOUS ADVERSE EVENT (SAE)? Tinnitus (ringing in ears) after taking an anti-histamine.

AE

What is an adverse event?

Adverse Event - An event, preventable or nonpreventable, that caused harm to a patient as a result of medical care. This includes never events; hospital-acquired conditions; events that required life-sustaining intervention; and events that caused prolonged hospital stays, permanent harm, or death.

IS THIS AN ADVERSE EVENT (AE) OR A SERIOUS ADVERSE EVENT (SAE)? Nausea and vomiting at day 7 of dosing.

Adverse Event - this is an untoward event experienced by the participant.

The following are key points to remember about data and safety monitoring:

Data and safety monitoring must occur periodically throughout every study. The frequency of monitoring is commensurate with the risks involved in the study, as well as the size and complexity of the study (i.e. a small, single-site Phase I trial versus a large, blinded, multi-site Phase III trial). Periodic data summary reports are prepared to determine if the study should change in any way or stop. Any significant changes in the study are implemented with the approval of the local IRB and reported to appropriate institutional officials, the study sponsor, and the FDA

Should drug abuse during a study be reported as an Adverse Event?

Drug abuse during a study should not be recorded as an AE unless it worsens during treatment (e.g., the participant is hospitalized for detoxification).

For participants that were screened, enrolled, and randomized sometime prior to experiencing the medical events described below, which are considered SAEs? A. Participant reports severe neck pain after a whiplash injury in a car accident that occurred in the previous week. B. Participant reports an ER visit due to pneumonia and was hospitalized subsequently for treatment with intravenous antibiotics. C. Participant with a history of mild asthma reports a 2-day hospital stay for severe asthma attack treatment in the study's final week. D. Participant (A) and (B) only E. Participant (B) and (C) only F. Participant (A) and (C) only

E) Correct! For Scenario B, the participant experienced a medical occurrence that led to hospitalization. For Scenario C, the participant's pre-existing condition worsened to require intensive treatment and a hospital stay. Both cases are considered SAEs.

The objectives of data and safety monitoring are to:

Ensure that risks of participation in a clinical study are minimized as far as is reasonably possible. Avoid exposing participants to excessive risk. Ensure the integrity of the data collected in a clinical study. Stop a study If safety concerns arise, or As soon as the study objectives have been overwhelmingly met, criteria usually spelled out before the study begins.

how many days after a sponsor learns about an AE does an investigator have until they need to report to the FDA?

FDA must be notified of serious, related and unexpected AEs associated with the use of the drug that are not fatal or life-threatening in a written safety report no later than 15 calendar days after the sponsor first learns of the event.

What is an adverse event in a behavioral study?

In certain studies, including some behavioral studies, it may be important to capture the occurrence of nonmedical events such as arrest, imprisonment, and violence to others, which may be contributing factors to an AE or may indicate that an AE has occurred

What is a intercurrent disease?

Intercurrent disease: A disease that intervenes during the course of another disease. A patient with AIDS may develop an intercurrent bout of pneumonia

how many days does the FDA require investigators to report threatening AEs?

Related and unexpected fatal or life-threatening AEs (severity grade 4 or 5) that are associated with the use of the drug must be reported to FDA by telephone or fax no later than 7 calendar days after the sponsor first learns of the event. This initial report must be followed within 8 additional calendar days by a written safety report that is as complete as possible.

The FDA defines a serious adverse event (SAE) as any untoward medical occurrence that:

Results in death, or Is life-threatening (places the patient at risk of death), or Requires hospitalization or prolongs an existing hospitalization, or Causes persistent or significant disability or incapacity, or Is a birth defect, or Requires medical intervention to prevent one of the above outcomes (e.g., an asthma attack that requires intensive treatment in an emergency room, a seizure that does not result in hospitalization but requires medical treatment).

IS THIS AN ADVERSE EVENT (AE) OR A SERIOUS ADVERSE EVENT (SAE)? Emergency hysterectomy during the study.

SAE Serious Adverse Event - This is emergency surgery and not planned.

IS THIS AN ADVERSE EVENT (AE) OR A SERIOUS ADVERSE EVENT (SAE)? Severe bronchospasms that resulted in ER visit for intervention

Serious Adverse Event - it meets the criteria of important medical event

Under these guidelines, expedited reporting to the FDA is generally not necessary for AEs that are:

Serious but expected. Serious but not related to the study drug, whether expected or not (e.g., a patient who dies of a cancer that was present prior to entry into a study of an antidepressant). Non-serious, whether expected or not.

Should Stable chronic conditions (e.g., arthritis) be considered AEs?

Stable chronic conditions (e.g., arthritis that is present before the participant enters a clinical trial and does not worsen) are not considered AEs. These conditions should be accounted for in the participant's medical history.

What does ADR stand for?

adverse drug reaction

What is an adverse drug reaction?

an adverse drug reaction (ADR) implies an adverse event that results from a medicine or treatment (i.e., there is a degree of relatedness between the adverse reaction and the treatment).

how soon does an investigator have until they need to report an SAE to the NIDA

any AE that meets FDA's criteria for a serious adverse event (SAE) must be reported within 24 hours to the NIDA Study Medical Officer and all parties specified in the protocol.

What is an untoward occurence?

characterized by misfortune, disaster, or annoyance · 2 not auspicious; adverse; unfavourable

CTN stands for?

clinical trial network

Severity of adverse event vs Seriousness ofAE?

everity refers to the intensity of a specific event (e.g., mild, moderate, or severe pain). However, the event itself may be of minor medical significance (e.g., a severe toothache) By contrast, the seriousness of an AE is assessed by the extent to which it poses a threat to the patient's life or functioning.

What is an adverse event in a behavioral study?

for a behavioral trial that does not involve treatment with a drug, an AE may be defined as: Any unfavorable, unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease that occurs during the study, having been absent at baseline, or—if present at baseline—appears to worsen.

Where do you document particpants' adverse events?

patient progress notes or case report form

What is an unanticipated problem?

related to a subject's participation in the research; and. suggests that the research places subjects or others at greater risk of harm - physical, psychological, economic or social harms - than was previously known or recognized.

If an AE is thought to have a causal relationship with the intervention, and the AE raises concern about the safety of the participant...

serious consideration must be given to temporarily halting or permanently discontinuing the intervention