Adverse Events

Ask closed questions

"What time did your symptoms start?"

SAEs may result in:

1. Modification of inclusion or exclusion criteria to mitigate the newly identified risks. 2. Implementation of additional procedures for monitoring subjects 3. Suspension of enrollment of new subjects 4. Suspension of research procedures in currently enrolled subjects 5. Modification of informed consent documents to include a description of newly recognized risks 6. Provision of additional information about newly recognized risks to previously enrolled subjects.

Required action for adverse events:

AEs must be reported to the IRB according to their SOPs. Reporting AEs to the sponsor will follow the specifics of the protocol.

Adverse Event Data Collection

Adverse event data may be obtained from observation of a participant, laboratory report, or report by participant. Often times, the majority of the AE information is collected from the participant. Effectively communicating with our participants is crucial in obtaining all data related to the symptom(s).

Required actions for unexpected adverse events:

An unexpected AE, whether serious or not, should be reported to the IRB and sponsor within 24hrs.

Unexpected Adverse Event

An unexpected or unanticipated adverse event is an AE that is not consistent with information found in the IB, the package insert, the protocol, or what is written in the risk section of the ICF.

Verbal techniques

Ask open-ended questions (ie "Tell me about your symptoms") Be sure to use layman's terms

Listen

Be sure the participant is finished speaking before asking the next question. Allow them to elaborate by giving a moment of silence prior to asking the question

Confirm

Be sure you understand the participant correctly. Demonstrate that you heard them and understood them. Use phrases like, "If I understand you correctly, you said..."

All other AEs should be reported to the IRB on the [?] form

Continuing Review

Serious Adverse Events

Depending on the nature of the study, the definition of an SAE may vary. The protocol and IRB SOPs will provide direction. In general, an SAE is any event that results in any of the following outcomes: 1. Death 2. Life threatening adverse drug experience 3. Inpatient hospitalization or prolongation of existing hospitalization 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect

Recording Adverse Events

Each single symptom, sign, or observed change is identified as a separate AE. This "splitting" approach to AE documentation is standard and helps to ensure complete collection of information. "Lumping" into illness or syndrome may be done later by an Investigator, according to protocol or Sponsor preference.

Clarify

If the participant reports having a stomach ache or other generalized symptom, use the AE Cued Details form to aid you in thinking of open-ended questions that might help the participant elaborate. For example "Tell me about your pain." "Is your symptoms similar to anything you've experience before?"

Non-verbal techniques

Listen, gesture (ie nod head). Provide positive feedback for the participant to continue giving information without interrupting.

True/False: Every Adverse Event must be reported to the IRB.

True

True/false: All adverse events regardless of severity, seriousness, and causality should be tracked and documented in a subject's source document and CRF.

True

True/false: Any AE that is related or possibly related or unexpected, whether serious or not, should be reported to the IRB and sponsor within 24 hours.

True

True/false: Serious adverse events (SAEs), whether related or not, should be reported to both the IRB and the sponsor within 24hrs.

True

Required action for Serious Adverse Events:

Upon evaluation of the reported AE, some or all of the following actions may be taken by the PI, IRB and or sponsor: Changes to the research protocol initiated by the investigator prior to obtaining IRB approval to eliminate apparent hazards to subjects.

Facilitate

Urge the participant to continue the discussion without interrupting by using phrases like "Go on" and "Uh huh"

Conclude

Use statements like, "I think I have all the information I need, is there anything else you'd like me to know?" This gives the participant another opportunity to provide additional details.

Reflect

Use the participant's statement as a question. For instance, a participant reports having a headache, you might say "So, you're having a headache, and...". Use caution with this technique as it is easily mistaken for mockery

Summarize

Verbally summarize the information the participant gave you. Again, this demonstrates that you've heard everything they have to say and understood it correctly.

Observe

What is the participant doing when they report the symptom? Is their behavior erratic? Are they uncomfortable? Do they avoid eye contact?

Adverse Event (AE)

any untoward medical occurrence that may present itself during treatment or administration with a pharmaceutical drug or device, and which may or may not have a causal relationship with the treatment

If the IB states that a headache may occur but does not list light sensitivity with the head ache and a subject presents with a head ache that includes light sensitivity, how should the AE be reported?

b. Unexpected AE

Who is responsible for determining the severity, causality, and seriousness of an AE?

c. PI

Who is responsible for documenting an AE/SAE?

d. All staff; PI will report to sponsor/IRB

Sponsor will collect AE information at interim [?]

monitor visits