Safety Reporting

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Safety Reporting

Corporate Headquarters: Corporate Headquarters:


Max House, G.F. Max House,G.F.

1 Dr. Jha Marg, Okhla


New Delhi 110020

1 Dr. Jha Marg, Okhla

New Delhi 110020 India India


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Definitions

What is an AE ? (1/3)
Adverse Event / Experience (AE):

Any unfavorable or unintended sign (including abnormal laboratory finding for example), symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to it

What is an AE ? (2/3)
This includes any undesirable signs experienced by the patient from signing of the informed consent until completion of the study [Week 78 (Day 545)]

Pre-existent disease signs, symptoms, and/ or laboratory abnormalities are not considered AE(s) unless

...these symptoms (AE) re-occur after the patient recovered or represent an exacerbation in intensity or frequency

What is an ADR ? (3/3)


All noxious and unintended responses to a medicinal product related to any dose

A causal relationship between the medicinal product and the Adverse Event is at least a reasonable possibility, i.e. the relationship cannot be ruled out

Classification

Adverse Events Classification

Seriousness Expectedness Severity Causal Relationship

Serious Adverse Event (1/3)


A SAE includes any event that results in one of the following: Death Life-threatening condition Requires or prolongs inpatient hospitalization A persistent or significant disability/incapacity A congenital anomaly / birth defect in an offspring of patient exposed to ADXS11-001

Important medical events that based on appropriate medical judgment may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above

Serious Adverse Event (2/3)

Life threatening The patient was at immediate risk of death from the adverse event as it occurred. (e.g. Anaphylaxis) Life threatening does not include that if an adverse event occurred in a more severe form, it might have caused death. Persistent or significant disability/incapacity Any adverse event that results in a substantial disruption of a persons ability to conduct normal life functions.

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Serious Adverse Event (3/3)


Important medical event

Event that may not be immediately life threatening, or result in death or hospitalization, but which may jeopardize the patient or may require intervention to prevent one of the other serious criteria

Based on Medical judgment


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Expectedness
Unexpected - Is any adverse event of which the specificity or severity is not consistent with the applicable product information. In clinical trials this generally refers to the current Investigator Brochure - Expectedness has nothing to do with expected complications of underlying disease

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Expectedness vs. Unexpectedness


An expected AE Nature and severity have been previously observed and documented for the study product An unexpected AE (Not previously observed) Any AE not consistent with protocol, current Investigators Brochure or general investigational plan

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Severity
Mild: symptom(s) barely noticeable to the patient; do not influence performance or functioning. Prescription RX usually not needed Moderate: symptom(s) of sufficient severity to make the patient uncomfortable; performance of daily activities is influenced; patient is able to continue in study; treatment may be needed Severe: symptom(s) causes severe discomfort the patient severe discomfort; severity may cause cessation of treatment with study drug; treatment of symptoms(s) may be given and/or patient hospitalized Life threatening: symptom(s) requires immediate treatment to prevent loss of life. Requires hospitalization & in-patient follow up

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Causality
Related (ADR) Definite Probable Possible

Not related Unlikely Not related

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Definite (All 4 criteria)


AE follows reasonable temporal sequence from time of drug administration AE cannot be reasonably explained by patients environmental/ toxic factors or other modes of therapy administered to patient The AE occurs immediately following drug administration, improves with de-challenge, reappear on re-challenge The AE follows a known response pattern of the study drug

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Probably related (3 out of 4 criteria)


AE follows reasonable temporal sequence from time of drug administration The AE follows a known response pattern of the study drug The AE cannot be reasonably explained by other factors such as the patients clinical state, therapeutic interventions or concomitant medications The AE is confirmed by improvement of symptoms on dechallenge of the suspected drug

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Possibly related (2 out of 3 criteria)

AE follows reasonable temporal sequence from time of drug administration The AE follows a known response pattern of the study drug The AE cannot be reasonably explained by other factors such as the patients clinical state, therapeutic interventions or concomitant medications administered to the patient

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Unlikely (2 out of 4 criteria)


The AE does not follow a reasonable temporal sequence from administration of study drug The AE could readily have been produced by patients clinical state, environmental/ toxic actors or other modes of therapy administered to the patient The AE does not follow a known response pattern to the suspected drug The AE does not reappear or worsen when the drug is readministered

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Not related
Those AE that are clearly and incontrovertibly due to extraneous causes (disease, environment, etc) as determined by the investigator

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Not a SAE !
The following cases do not constitute a hospitalization (unless they meet other SAE definitions): Emergency Room visits with patient treated and released < 24 hrs Patient in for observation < 24 hrs, but not admitted Out patient treatment, <24 hrs

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Pregnancy
Pregnancies occurring between the signing of the informed consent form till the end of study (week 78, day 545) the last dose of ADXS11-001 must be reported by the site staff within 24 hours of their knowledge of the event using the SAE Form Any patient who becomes pregnant during participation in this study must be promptly withdrawn from the study Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the infant will be required

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Players in Safety Monitoring

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Players in Safety Monitoring


Ethics Committee

Regulatory agency (DCGI)

Safety Monitoring

Investigator

Sponsor /Designee (CRO)

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SAE reporting timelines

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SAE reporting timelines


Investigator Sponsor/designee (within 24 hrs of detection of the event) Investigator Ethics Committee (within 7 working days of detection of event)

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USAE reporting timelines


Sponsor calendar days of detection) Regulatory authority (within 14

Sponsor Other participating investigators (within 14 calendar days of detection)

To the respective Ethics Committees

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Principal Investigator Responsibilities


Medical management of the adverse event(s) Train the site personnel Assessing AEs Reporting AEs Inform sponsor about all SAEs within 24 hrs Responsibility towards IRB/EC Informing IRB/EC within 7 working days or as per their SOPs whichever is stringent

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Study Coordinator Responsibilities


Inform the PI about the adverse event(s) Collecting information regarding adverse Sending the IND safety reports to IRB Informing IRB as per their SOPs

event(s)

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Thank You

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