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Susan Tse, RN, BSN, CCRPJansina Fok, BS, CCRP
*Adverse Events
* Any untoward medical event that occurs while a
patient is on a clinical trial. It can be a sign, symptom, or disease
temporally associated with the investigational agent.
Adverse Event
* Subject Safety* Inform Others* Trial Analysis* Toxicity Profile
*Why do we collect AE’s?
*Adverse Events
• The investigator is responsible for protecting the rights, safety for protecting the rights, safety and welfare of subjects 21CFR 312.60
• Ongoing safety evaluation of the investigational product/s being tested in a clinical trial, is essential in maintaining the safety of human subjects
• Do you have the necessary knowledge and training to be able to capture this valuable information by:• Identifying the events that impact safety• Document these events appropriately • Report
* Recording Adverse Events
Depends upon: 1. Phase of the study 2. PI3. Sponsor4. Department* Phase 1 trial usually capture all AE regardless of grade* Phase 4 trial is the post market approval, all AE may not need to be captured mostly
for unexpected or not known to be occurred* Before the study is activated, it is important for all clinical trial staff to know what AE
needs to be captured, consistent for all subjects
*How do we Report AE’s?
*The event should be reported in medical terminology.*The relationships must be listed.*The grade should be listed using CTCAE
guidelines.*If the event meets the requirements of an
SAE, it should be reported as such.
*Elements of Adverse Event
*Grade Found in CTCAE*Event Found in CTCAE*Attribution relationship to the
study agent or intervention decided by PI or collaborating
physician*Duration start and stop date
*Purpose of CTCAE
• Standardize AE reporting in Oncology Research Community
• Facilitate evaluation of new cancer therapies, treatment modalities, and supportive measures
• Aid in AE recognition and grading• Monitor safety data and for regulatory reporting• Define oncology research protocol parameters
Such as Eligibility, Dose Limiting Toxicity, Maximum Tolerated Dose, Dose Modification
*CTCAE V4.0 or V3.0
GradeTerm
* Documenting Adverse Events
*Clinic Station dictations*Progress notes*Telephone documentation forms *Emergency Room assessments*Follow up visit notes*Adverse Events tracking forms*Medication Administration Records*Diagnostic reports*Outside correspondence*Patient diaries
*An Adverse Event can be
*Related*Expected*Serious*Internal
*Unrelated*Unexpected*Not serious*External
*Attribution
*Related or unrelated?*The attending decides. The attending can
be overridden by the PI.
Expected* Is listed in the informed
consent or investigators brochure.
Unexpected* Is not listed in the
informed consent or investigators brochure.
* Is a nature, severity, or frequency that is different than what is listed.
*Expected or unexpected?
Serious* Results in death* Life threatening and puts the
patient at immediate risk of death
* Results in persistent or significant disability/incapacity
* Requires or prolongs hospitalization
* Results in a congenital anomoly/birth defect
* Is an important medical event
Not serious*Does not meet serious
requirements.
*Serious or not serious?
Internal*Occurs with a patient at
your site on your trial.*Reported to you by the
patient, family member, or physician.
External*Occurs to a patient at
another site. *Reported to you by the
sponsor.
*Internal or External
*Reporting at MDA
What form?
*External SAE’s
*Are reported immediately if they are related, unexpected, and serious. *All reportable external SAEs are to be
reported within 5 working days (including unanticipated death)*If they do not meet the above
requirements, they do not need to be reported to MDA IRB.
*Internal SAE’s
*If it is serious, related, and unexpected, it must be immediately reported within 5 days.*If it is unanticipated death and related, it
must be reported within 24 hours *If it does not meet the criteria, it must be
listed on the Internal SAE Log. *This log is submitted with your annual
report.*You must complete all known information
on this log.
*What is wrong with these?
