Tracy Walker, RN, BSN, CCRP Research Nurse OHSU Knight Cancer Institute
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1 Tracy Walker, RN, BSN, CCRP Research Nurse OHSU Knight Cancer Institute
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?
3 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
4 Unanticipated Problems Remember: Must fit all On Protocol 2. SAE 3. Unanticipated 4. Related or 2 1. On Protocol 2. Anticipated AE or SAE 3. Related or 4. Occurring at a higher frequency or severity 1. Unanticipated AE or SAE 2. Related or 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process 4 1. Unanticipated 2. Other events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. If event does not fit, it is not reportable.
5 Adverse Events Reporting Exercise A Phase II Trial of the Safety and Efficacy of Abc- 001 for the Treatment of CoordinatorStressitis 2 yr trial Abc mg tablet daily PO 30 subjects Age > 18 years Dx: occupation in research
6 Investigator s Brochure Drug: Abc-001 Common side effects Nausea Vomiting Diarrhea Abdominal pain Abnormal LFT s Rash Low K+ Elevated QTc Headaches Serious reactions Death Respiratory distress Severe neutropenia Hepatitis Excessive bleeding 9/29/201
7 History for Subject 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 Meds: Zyrtec, multi-vitamin, ibuprofen
8 Physical for Subject 507 Alert, oriented, NAD Normal physical exam BP 110/70, HR 76
9 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.
10 Subject Diary 1/10/10 Anxiety attack had to miss work. Felt nervous all day. 1/12/10 Feeling better. Back at work.
11 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?
12 Unanticipated Problems Remember: Must fit all On Protocol 2. SAE 3. Unanticipated 4. Related or 2 1. On Protocol 2. Anticipated AE or SAE 3. Related or 4. Occurring at a higher frequency or severity 1. Unanticipated AE or SAE 2. Related or 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process 4 1. Unanticipated 2. Other events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. If event does not fit, it is not reportable.
13 Progress Note 1/22/10 Subject 507 in for study visit. Reports nausea lasting 2 hours on 1/18/10.
14 Investigator s Brochure Drug: Abc-001 Common side effects Nausea Vomiting Diarrhea Abdominal pain Abnormal LFT s Rash Low K+ Elevated QTc Headaches Serious reactions Death Respiratory distress Severe neutropenia Hepatitis Excessive bleeding 9/29/201
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 On Protocol 2. SAE 3. Unanticipated 4. Related or 2 1. On Protocol 2. Anticipated AE or SAE 3. Related or 4. Occurring at a higher frequency or severity 1. Unanticipated AE or SAE 2. Related or 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process 4 1. Unanticipated 2. Other events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. If event does not fit, it is not reportable.
17 Progress Note 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.
18 Investigator s Brochure Drug: Abc-001 Common side effects Nausea Vomiting Diarrhea Abdominal pain Abnormal LFT s Rash Low K+ Elevated QTc Headaches Serious reactions Death Respiratory distress Severe neutropenia Hepatitis Excessive bleeding 9/29/201
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 On Protocol 2. SAE 3. Unanticipated 4. Related or 2 1. On Protocol 2. Anticipated AE or SAE 3. Related or 4. Occurring at a higher frequency or severity 1. Unanticipated AE or SAE 2. Related or 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process 4 1. Unanticipated 2. Other events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. If event does not fit, it is not reportable.
21 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. Vital signs: BP 170/95, HR 90
22 Investigator s Brochure Drug: Abc-001 Common side effects Nausea Vomiting Diarrhea Abdominal pain Abnormal LFT s Rash Low K+ Elevated QTc Headaches Serious reactions Death Respiratory distress Severe neutropenia Hepatitis Excessive bleeding 9/29/201
23 Unanticipated Problems Remember: Must fit all On Protocol 2. SAE 3. Unanticipated 4. Related or 2 1. On Protocol 2. Anticipated AE or SAE 3. Related or 4. Occurring at a higher frequency or severity 1. Unanticipated AE or SAE 2. Related or 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process 4 1. Unanticipated 2. Other events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. If event does not fit, it is not reportable.
24 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.
25 Investigator s Brochure Drug: Abc-001 Common side effects Nausea Vomiting Diarrhea Abdominal pain Abnormal LFT s Rash Low K+ Elevated QTc Headaches Serious reactions Death Respiratory distress Severe neutropenia Hepatitis Excessive bleeding 9/29/201
26 Progress Note 2/20/10 Someone broke into your car and stole a few items including the laptop on which you keep data for this study.
27 Unanticipated Problems Remember: Must fit all On Protocol 2. SAE 3. Unanticipated 4. Related or 2 1. On Protocol 2. Anticipated AE or SAE 3. Related or 4. Occurring at a higher frequency or severity 1. Unanticipated AE or SAE 2. Related or 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process 4 1. Unanticipated 2. Other events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. If event does not fit, it is not reportable.
28 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.
29 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.
30 Investigator s Brochure Drug: Abc-001 Common side effects Nausea Vomiting Diarrhea Abdominal pain Abnormal LFT s Rash Low K+ Elevated QTc Headaches Serious reactions Death Respiratory distress Severe neutropenia Hepatitis Excessive bleeding 9/29/201
31 Unanticipated Problems Remember: Must fit all On Protocol 2. SAE 3. Unanticipated 4. Related or 2 1. On Protocol 2. Anticipated AE or SAE 3. Related or 4. Occurring at a higher frequency or severity 1. Unanticipated AE or SAE 2. Related or 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process 4 1. Unanticipated 2. Other events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. If event does not fit, it is not reportable.
32 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 Investigator s Brochure Drug: Abc-001 Common side effects Nausea Vomiting Diarrhea Abdominal pain Abnormal LFT s Rash Low K+ Elevated QTc Headaches Serious reactions Death Respiratory distress Severe neutropenia Hepatitis Excessive bleeding 9/29/201
34 Unanticipated Problems Remember: Must fit all On Protocol 2. SAE 3. Unanticipated 4. Related or 2 1. On Protocol 2. Anticipated AE or SAE 3. Related or 4. Occurring at a higher frequency or severity 1. Unanticipated AE or SAE 2. Related or 3. May alter the risks and therefore warrants changes to the protocol, DSMP, or consent process 4 1. Unanticipated 2. Other events 3. May place subjects or others at greater risk of harm or discomfort. Harm need not have occurred. If event does not fit, it is not reportable.
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: Bridge
37 Questions? Comments?
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