Tracy Walker, RN, BSN, CCRP Research Nurse OHSU Knight Cancer Institute

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Tracy Walker, RN, BSN, CCRP

Research Nurse

OHSU Knight Cancer Institute

503-346-1183

(2)

Exercise Questions to Keep in Mind

• Is there an adverse event?

• What is the severity?

• What is the relationship to study drug?

• Is it a serious adverse event?

• Is it an unanticipated problem?

• Does it need to be reported?

• To whom do you report?

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Safety Reporting Definitions

• Serious adverse experience (21CFR312.32)

–

Any adverse experience occurring at any dose that results in any

of the following outcomes:

• death

• life-threatening adverse experience

• in-patient hospitalization or prolongation of existing

hospitalization

• persistent or significant disability/incapacity

• congenital anomaly/birth defect

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Unanticipated Problems – Remember: ‘Must fit all’

1. On Protocol 2. SAE 3. Unanticipated 4. Related or Possibly Related Category 1 1. On Protocol 2. Anticipated AE or SAE 3. Related or Possibly Related 4. Occurring at a higher frequency or severity Category 2 1. Unanticipated AE or SAE 2. Related or Possibly Related 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process Category 3 1. Unanticipated 2. ‘Other’ events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. Category

4

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A Phase II Trial of the Safety and Efficacy of

Abc-001 for the Treatment of CoordinatorStressitis

2 yr trial

Abc-001 50 mg tablet daily PO

30 subjects

Age > 18 years

Dx: occupation in research

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9/29/201 4

Investigator’s Brochure

Drug:

Abc-001

Serious reactions

• Death

• Respiratory distress

• Severe neutropenia

• Hepatitis

• Excessive bleeding

Common side effects

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Abnormal LFT’s

• Rash

• Low K+

• Elevated QTc

• Headaches

(7)

History for Subject 507

• 41 year old female otherwise in good general health

• Diagnosis of occupation in research

• Medical hx: asthma, allergies

• Complains of intermittent, mild headaches

• No known drug allergies

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Physical for Subject 507

• Alert, oriented, NAD

• Normal physical exam

• BP 110/70, HR 76

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Progress Note

1/3/10 Subject 507 in for study visit. Reports feeling her

usual self. Takes study drug regularly. No side

effects reported. No change in concomitant

medications.

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Subject Diary

1/10/10 Anxiety attack had to miss work. Felt nervous

all day.

1/12/10 Feeling better.

Back at work.

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Exercise Questions to Keep in Mind

• Is there an adverse event?

• What is the severity?

• What is the relationship to study drug?

• Is it a serious adverse event?

• Is it an unanticipated problem?

• Does it need to be reported?

• To whom do you report?

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Unanticipated Problems – Remember: ‘Must fit all’

4

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Progress Note

1/22/10 Subject 507 in for study visit. Reports nausea

lasting 2 hours on 1/18/10.

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9/29/201 4

Investigator’s Brochure

Drug:

Abc-001

Serious reactions

• Death

• Respiratory distress

• Severe neutropenia

• Hepatitis

• Excessive bleeding

Common side effects

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Abnormal LFT’s

• Rash

• Low K+

• Elevated QTc

• Headaches

(15)

Exercise Questions to Keep in Mind

• Is there an adverse event?

• What is the severity?

• What is the relationship to study drug?

• Is it a serious adverse event?

• Is it an unanticipated problem?

• Does it need to be reported?

• To whom do you report?

(16)

Unanticipated Problems – Remember: ‘Must fit all’

4

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1/27/10 Reports fractured ankle from falling off a horse.

Outpatient surgical repair with excessive bleeding that

required overnight hospitalization. Study drug held for 2

weeks. Vicodin added to concomitant medications.

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9/29/201 4

Investigator’s Brochure

Drug:

Abc-001

Serious reactions

• Death

• Respiratory distress

• Severe neutropenia

• Hepatitis

• Excessive bleeding

Common side effects

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Abnormal LFT’s

• Rash

• Low K+

• Elevated QTc

• Headaches

(19)

Exercise Questions to Keep in Mind

• Is there an adverse event?

• What is the severity?

• What is the relationship to study drug?

• Is it a serious adverse event?

• Is it an unanticipated problem?

• Does it need to be reported?

• To whom do you report?

(20)

Unanticipated Problems – Remember: ‘Must fit all’

4

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Progress Note

2/2/10 Subject 507 in for study visit. Reports recovering

from ankle fracture. Complains of increased headaches.

Doubled her use of ibuprofen, continues pain medication

and no change in other meds. Headaches are so severe,

subject could not go to work.

(22)

9/29/201 4

Investigator’s Brochure

Drug:

Abc-001

Serious reactions

• Death

• Respiratory distress

• Severe neutropenia

• Hepatitis

• Excessive bleeding

Common side effects

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Abnormal LFT’s

• Rash

• Low K+

• Elevated QTc

• Headaches

(23)

Unanticipated Problems – Remember: ‘Must fit all’

4

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Progress Note

2/15/10 Subject 507 in for study visit. Reports cold

symptoms of runny nose and non-productive cough. Took

cold remedies for 2 days. Does not recall the medication

names, doses or dates taken.

Plan: Review the importance of keeping track of dates and

any concomitant medications while participating in a study.

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9/29/201 4

Investigator’s Brochure

Drug:

Abc-001

Serious reactions

• Death

• Respiratory distress

• Severe neutropenia

• Hepatitis

• Excessive bleeding

Common side effects

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Abnormal LFT’s

• Rash

• Low K+

• Elevated QTc

• Headaches

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• 2/20/10 Someone broke into your car and stole a few

items … including the laptop on which you keep data

for this study.

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Unanticipated Problems – Remember: ‘Must fit all’

4

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Progress

Note

3/3/10 Subject 507 in for study visit.

Reports stomach ache about 30 minutes

after taking study drug. Lasts 1 hour,

does not require medication or interfere

with her usual activity.

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Progress Note

3/15/10 Subject 507 in for study visit. Reports rapid

onset of intermittent blurred vision beginning 3/9/10

and lasting 3 days. Reports no other problems.

Continues study drug and no change in concomitant

medications.

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9/29/201 4

Investigator’s Brochure

Drug:

Abc-001

Serious reactions

• Death

• Respiratory distress

• Severe neutropenia

• Hepatitis

• Excessive bleeding

Common side effects

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Abnormal LFT’s

• Rash

• Low K+

• Elevated QTc

• Headaches

(31)

Unanticipated Problems – Remember: ‘Must fit all’

4

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Progress Note

4/15/10 Subject reports having horrible nightmares.

According to her spouse, she is sleep walking and

has become a danger to herself.

Subject is admitted to the sleep unit for overnight

observation.

(33)

9/29/201 4

Investigator’s

Brochure

Drug:

Abc-001

Serious reactions

• Death

• Respiratory distress

• Severe neutropenia

• Hepatitis

• Excessive bleeding

Common side effects

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Abnormal LFT’s

• Rash

• Low K+

• Elevated QTc

• Headaches

(34)

Unanticipated Problems – Remember: ‘Must fit all’

4

(35)

Exercise Questions

• Is there an adverse event?

• What is the severity?

• What is the relationship to study drug?

• Is it a serious adverse event?

• Is it an unanticipated problem?

• Does it need to be reported?

• To whom do you report?

(36)

AE tracking logs

Link to AE tracking logs on the Bridge:

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