adverse events project

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?

*Questions

*Clinicalresearchsupport@mdanderson.org*ncictcashelp@mail.nih.gov