This document discusses adverse events and serious adverse events in clinical trials. It reviews FDA inspection findings related to reporting adverse events and the regulations surrounding adverse event reporting. It outlines how adverse events should be recorded, including source documentation and attribution. It also discusses reporting criteria and timelines for reporting adverse events to sponsors and regulatory bodies. Finally, it reviews considerations for auditing adverse events, such as whether events were properly graded and reported.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Overview of Validation in Pharma_Katalyst HLSKatalyst HLS
Introduction to Validation Concepts in Pharma, Bio-Pharma, Medical Device, Cosmetics, Food, Beverages industry.
Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com
Study setup_Clinical Data Management_Katalyst HLSKatalyst HLS
Introduction to Study Setup in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Introduction to Argus Event Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Oracle Clinical Overview in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Introduction to Argus Analysis Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Argus Screen Shots General Tab - Katalyst HLSKatalyst HLS
Introduction to Argus Screen Shots General Tab - Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
ARGUS Query Process Overview_Katalyst HLSKatalyst HLS
Introduction to ARGUS Query Process Overview in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Pharmacovigilance in USA and Europe_Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in USA and Europe for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Argus Product Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Screening for disease or Early detection of disease is detecting a disease at an earlier stage than would usually occur in standard clinical practice.
This denotes detecting disease at a pre-symptomatic stage, at which point the patient has no clinical complaint ( no symptoms or signs) and therefore no reason to seek medical care for the condition
Early detection of disease is beneficial and that intervention at an earlier stage of the disease process is more effective or easier to implement than a later intervention
Adverse Event Reporting in Pharmacovigilance: Principles and ChallengesClinosolIndia
Adverse event reporting is a crucial component of pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Here are the principles and challenges associated with adverse event reporting in pharmacovigilance:
Principles:
Timeliness: Adverse events should be reported promptly to ensure timely assessment and appropriate action. Reporting delays can hinder the detection of safety signals and the implementation of necessary interventions.
Completeness: Comprehensive reporting of all relevant information regarding the adverse event is vital. This includes patient demographics, medical history, drug details (name, dose, route of administration), onset and duration of the event, outcomes, and any concomitant medications.
Causality Assessment: Adverse events should be evaluated for their potential causality with the suspected drug. This involves considering factors such as temporal relationship, dechallenge/rechallenge information, and the presence of alternative explanations or confounding factors.
Confidentiality and Privacy: Adverse event reporting must uphold patient confidentiality and privacy. Personal identifiable information should be protected, and data should be handled in accordance with applicable data protection regulations.
Collaboration and Communication: Effective communication and collaboration between healthcare professionals, regulatory authorities, pharmaceutical companies, and patients are essential. Sharing information and feedback helps in improving patient safety and optimizing the understanding of adverse events.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Preventing Medication Errors: A $21 Billion OpportunityHealth Catalyst
With a potential industry-wide savings of almost $21 billion and an impact on more than seven million patient lives, preventing harmful medication error is a significant improvement opportunity for health systems. Also known as adverse drugs events (ADEs), harmful medication errors comprise about 37 percent of all medical harm. Approximately 50 percent of ADEs are preventable, making their reduction a highly impactable area of patient safety.
Current data and analytics workflow tools are making ADE surveillance, monitoring, and prevention increasingly more effective with four key capabilities:
Perspective surveillance for ADEs and identification of previously undescribed ADEs.
Identification of the root cause of many ADEs by drug class.
Prescription at appropriate doses for patients with compromised kidney or liver functions.
Identification of different types of harm to find causes.
Introduction to Adverse Drug Reactions in Pharmacovigilance and Drug Safety in Pharma, Biotech, Medical Device, Cosmeceutical and Foods.
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"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
2. Objectives:
Recognize Adverse Events and Serious Adverse Events
Review FDA inspection findings related to Adverse Events
Review regulations related to Adverse Events
Discuss recording and reporting of Adverse Events
Discuss auditing of Adverse Events
Demonstrate audit of Adverse Events
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3. FDA Inspection:
“Failure to prepare and submit complete and
accurate and timely reports of unanticipated
adverse device effects”
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5. Adverse Events:
Any adverse event associated with the use of a drug in
humans, whether or not considered related.
21CFR 314.80
Any untoward medical occurrence in a patient
administered a pharmaceutical product and which does
not necessarily have a causal relationship with the
treatment
ICH E6
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6. Adverse Event:
NCI
An unexpected medical problem that occurs during
treatment with a drug or other therapy.
Adverse events do not have to be a caused by the
drug or therapy
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8. Expected Vs. Unexpected
Expected
Known to Occur and is
Listed in the
Investigational Brochure,
Informed Consent, or
General Investigational
Plan
Unexpected
Not listed in Investigational
Brochure, Informed
Consent, or General
Investigational Plan
Also not listed in a drug
package insert
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10. Recording:
Know which adverse events the protocol requires to be captured
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11. Source Documentation:
Source Documentation of adverse events include
documentation in the medical records of:
Event
Date it occurred
Grade as determined by CTCAE
Expected or Unexpected
Attribution as assigned by PI
Date resolved
Treatment patient received specifically related to event
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12. Sample Adverse Event Recording Form
See template behind this presentation
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14. Attribution (Causality)
The attribution (relationship or causality or drug
related assessment) must be determined
A determination made by a clinical investigator
that describes the relationship or association of the
study product with an adverse experience
This determination must be recorded both in the
medical record as well as in the case report form.
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15. Attribution
What should the investigator consider
prior to assigning attribution?
Individual medical history
Known effects of concomitant medications
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16. Attribution:
Definite – Clearly related to study agent
Probable – Likely related to study agent
Possible – May be related to study agent
Unlikely – Doubtfully related to study agent
Unrelated – Clearly not related to study agent
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17. How to Capture Adverse Events?
Split or Lumped
Fever, Diarrhea, and Vomiting (Viral
Gastroenteritis)
Cough, Sniffles, Sore throat (Flu)
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18. How to Capture Adverse Events?
Problems with similar terms
Rash or Dermatitis
Wheezing, reactive airway disease, congestion,
cold, , asthma
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19. Documenting Resolution Dates:
Challenge
Does the patient remember when their adverse event
resolved?
Do you call the patient? Or wait till the next visit?
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20. Patient Toxicity Diary:
Diaries where patients capture toxicities
between their follow up appointments
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21. Patient Toxicity Diaries:
Patient writes down constipation because he did not have
a bowel movement one day
Research nurse captures constipation without assessing further
Physician copies the research nurse’s note and also dictates
constipation
Did anyone ask about the constipation?
According to CTC V3, constipation is grade 1 only if there is
occasional or intermittent symptoms; occasional use of stool
softeners, laxatives, dietary modification, or enema
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22. Patient Adverse Event Diaries:
Advantages
Allows capturing
information on a daily basis
while patient is away from
clinic
A communication tool for
patient returns to clinic
Useful in capturing onset
and resolution dates of
adverse events
Disadvantages
Time consuming
Patient non-compliance
Patient self diagnosis or
interpretation
Complicated Instructions
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23. Question to Ask:
When should site staff begin collecting
adverse event information?
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24. Question to Ask:
How long should one collect adverse
events after the subject completes study
treatment?
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26. Reporting Serious Events
An investigator must promptly report to the
sponsor any adverse effect that may reasonably
be regarded as caused by or probably caused
by the drug. If the adverse effect is alarming, the
investigator shall report the adverse effect
immediately.
21CFR312.64
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27. Reporting Criteria:
Routine Reporting
Know which events can be reported at
interim analysis or annual reviews
Expedited Reporting
Know which events require immediate
reporting
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28. Reporting Criteria
Know which type of expedited reports each
regulatory body requires
FDA
Sponsor
Co-Sponsor
MD Anderson
NCI
Collaborative Groups
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29. Issues in Reporting:
Primary events
Example
Patient admitted with Congestive Heart Failure
Subsequently develops: Pulmonary Edema and
Cardiogenic Shock
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30. Consequences of Improper Reporting
Protocol Violations
IRB will close protocol
FDA Hold
Sponsor Hold
Research Privileges Revoked
Patient Safety
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32. Auditing Check Points
Was the event a dose limiting toxicity?
Should the dose have been reduced?
If so, did the research team realize it as such and identify it
correctly?
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33. Auditing Check Points
How are AEs being recorded in the medical
record?
Does documentation include grade, onset,
resolution, and attribution?
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34. Auditing Check Points
Were all toxicities included?
Was the proper CTCAE version used for the
protocol?
Were the toxicities graded appropriately?
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35. Auditing
Are adverse events appropriately reported
within the time periods required by regulations,
sponsor, and IRB policies?
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36. We have reviewed……….
Recognizing adverse events and serious adverse events
Inspections and findings related to adverse events
Regulations related to adverse events
Recording and reporting of adverse events
Auditing of adverse events
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First we will cover recognizing Adverse Events and Serious Adverse Events
Although the definitions in the regulations address drugs, we expand the definition for those trials that do not involve drugs.
This slide lists the event outcomes that are considered serious.
Fun way to remember which events are classified as serious
Fred Doesn’t Have Any Money Left (Wilma went shopping at the Bedrock Mall!)
Serious Adverse Events are those associated with the patient’s participation in research that:
Results in fatality– “Fred”
Results in persistent or significant disability/incapacity – “Doesn’t”
Results in patient hospitalization or prolongation of existing hospitalization – “Have”
Results in a congenital anomaly or birth defect – “Any”
A Medically significant event- “Money”
What is considered medically significant?...
Patient has baseline creatinine of 1.8 due to a renal condition which is Grade 1, not too high but now creatinine jumped to 8. A creatinine of 8 is clinically significant.
Lastly, event is life threatening– “Left” Life threatening events include:
Any adverse pharmaceutical product that places the patient, in the view of the PI, at immediate risk of death from the reaction as it occurred OR if it is suspected that continued use of the product under investigation would result in pt’s death Examples: allergic bronchospasm requiring intensive treatment, gastrointestinal hemorrhage, pacemaker failure
To determine if an event is expected or unexpected
Check Investigational Brochure, Informed Consent or General Investigational Plan
To see if the event is listed
If the event is listed, then it is expected
If not, the event is unexpected
Next, talk about recording adverse events.
Sometimes we forget how unique our different protocols are and we go along doing the same thing for every protocol.
Need to be familiar with what adverse events your protocol requires to be captured.
This will vary with your sponsor and with your PI
For example, for a particular protocol, sponsor may only require that you capture Grade 3 or Grade 4 adverse events
Could cut down on your work if that is the case
PI may want to capture every adverse event
This is certainly something you want to discuss with both sponsor and PI before begin protocol
In order to adequately capture the information to document an adverse event, you need to include:
Event
Date it began
Grade as determined by the appropriate Common Terminology Criteria for Adverse Events
Whether or not it was expected or unexpected
Must have relationship of event to study agent assigned by PI
Date event ended
Document any treatment patient received as a result of the event (took Neurontin for neuropathy, specify dose)
Here is an example of a template that contains all the required elements and place for physician who is assigning attribution to sign.
You decide what form of documentation works best for your protocol to prompt you to include all of the necessary information including the physician’s signature to confirm the PI is in agreement with the assignment of the attribution of the study product to the event.
Very important part of documentation of adverse events is documentation as to if the event was related to or caused by the pharmaceutical product.
The relationship between the study product and the event must be decided by the clinical investigator and this attribution must be documented indicating the attribution was assigned by the investigator.
BECAUSE, assigning attribution is a medical judgment. And, all AEs are to be communicated to the PI
Plan the best way to document the attribution in the medical record as well as providing a source that the investigator assigned that relationship.
Audits reveal that attribution is found in the CRF but not in source documents.
Once again, the determination of attribution is a medical judgment because patients on study trials come with other medical conditions .
The physician must take into consideration the patient’s co-morbidities in order to make an adequate assessment of the relationship between the study agent and the adverse event.
Some sponsors want the symptoms lumped and others want it separated.
Regardless of how these are captured, we must try to stay consistent.
Reference: When a Cough is Just a Cough: The Trouble with Aes
Herschel R. Lessin, MD
Sometimes documenting adverse events can be a challenge.
Patients and healthcare workers interchangeably will use terms for symptoms described by subjects.
This is protocol specific. Most of the time, study staff collect information from the time informed consent is obtained.
Generally, reporting of serious events are not required until administration of the investigational product or protocol intervention.
P. 262
There are no requirements or regulations that specify the length of time that Adverse events that should be collected after a subject completes the study treatment period. The protocol should clearly define this. A 30 day follow up period is common. Investigators should consider half lives of investigational products, prior experience with the product, and any delayed adverse event concerns prior to establishing a cut off date or time point.
We have talked about recognizing and recording adverse events, now let’s talk about reporting adverse events!
Investigators assigning attribution is addressed here as well. If the investigator is not aware of adverse events and assign attribution, how can he or she follow this regulation?
Need to be familiar with the reporting requirements for your protocol
Once again, be familiar with your protocol
In some protocols, you will be responsible for providing data for the interim analysis (point where evaluate data) or for the annual review
Need to know which events require immediate reporting
Although MD Anderson IRB requires only prompt reporting :
of deaths
and serious, related and unexpected events
Other sponsors might have additional requirements.
Some sponsors require you to report all serious adverse events regardless of the relationship.
Often times, patients are admitted with one diagnosis such as this one. Following admission, secondary events are found.
All of these can be reported using one form listing CHF as the primary event for example here.
Now we are going to talk about what we are here for today….auditing!
Documentation of a dose limiting toxicity is tremendously important!
That is not only for source documentation purposes, but also for patient safety issues.
Your patient shows up in the ER and there is a good chance the only documentation of a dose reduction would be your notes.
Be sure that all adverse events are documented appropriately to include the:
Event
Dates for beginning and end
Grade
Was the event resolved
Was it expected or unexpected
Documentation of the attribution assigned by the PI
Documentation of any treatment patient received as a result of the event
Were all toxicities included?
In addition to adverse events described by the patient, are there any abnormal lab values or has
something shown up on any scans or x-rays?
Even though newer protocols require Version 3 of the CTCAE, is that the case for this particular protocol?
Were the toxicities actually graded according to the descriptions provided in the Common Terminology Criteria for Adverse Events?