The document provides an overview of clinical study protocols, including their purpose, key components, and importance. It describes the various sections of a protocol, such as the background and objectives, study design, subject selection criteria, study procedures, safety and efficacy assessments, and data handling. Maintaining adherence to the protocol is important to ensure the safety of participants and integrity of the clinical trial.
Clinical Data Management (CDM) is a critical component of clinical research that involves the collection, cleaning, validation, and management of clinical trial data to ensure its accuracy, integrity, and compliance with regulatory requirements. The workflow of CDM typically consists of several key stages, each with specific activities and processes. Here is an overview of the typical workflow of CDM:
Study Startup:
Protocol Review: CDM teams begin by reviewing the clinical trial protocol to understand the study's objectives, endpoints, data collection requirements, and timelines.
Database Design: Based on the protocol, the team designs a data capture system or electronic data capture (EDC) system. This includes creating data entry forms, defining data validation checks, and setting up data dictionaries.
Data Collection:
Case Report Form (CRF) Design: CDM professionals design electronic or paper CRFs to collect data during the trial. CRFs capture specific data points required by the protocol.
Data Entry: Data is entered into the CRFs, either electronically by site personnel or through paper CRFs.
Data Validation: CDM teams implement validation checks to ensure data quality and consistency. Data validation checks may include range checks, consistency checks, and logic checks.
Query Management: Queries are generated when data discrepancies or inconsistencies are identified. CDM teams send queries to investigational sites for resolution.
Data Cleaning and Quality Control:
Data Cleaning: Data are cleaned to resolve discrepancies, discrepancies, and inconsistencies. This involves querying data discrepancies with clinical trial sites.
Data Review: CDM teams review data to ensure completeness and accuracy, and any outstanding queries are resolved.
Quality Control: Quality control processes are applied to verify the integrity and accuracy of data.
Database Lock:
Once the data are cleaned, reviewed, and validated, the database is locked, indicating that no further changes can be made to the data. Database lock is a critical step before data analysis begins.
Data Export and Analysis:
Data is exported from the database and provided to biostatisticians and researchers for statistical analysis. This analysis is conducted to determine the study's outcomes, efficacy, and safety profile.
Data listings, summaries, and tables are generated for regulatory submissions, reports, and publications.
Final Study Reporting:
After data analysis, CDM teams contribute to the preparation of final study reports, which provide a comprehensive overview of the trial's results, data quality, and regulatory compliance.
Archiving and Documentation:
Clinical trial data, documentation, and databases are archived to ensure their long-term availability for regulatory audits and future reference.
Regulatory Submission: CDM teams provide support for regulatory submissions.
Clinical Data Management (CDM) is a critical component of clinical research that involves the collection, cleaning, validation, and management of clinical trial data to ensure its accuracy, integrity, and compliance with regulatory requirements. The workflow of CDM typically consists of several key stages, each with specific activities and processes. Here is an overview of the typical workflow of CDM:
Study Startup:
Protocol Review: CDM teams begin by reviewing the clinical trial protocol to understand the study's objectives, endpoints, data collection requirements, and timelines.
Database Design: Based on the protocol, the team designs a data capture system or electronic data capture (EDC) system. This includes creating data entry forms, defining data validation checks, and setting up data dictionaries.
Data Collection:
Case Report Form (CRF) Design: CDM professionals design electronic or paper CRFs to collect data during the trial. CRFs capture specific data points required by the protocol.
Data Entry: Data is entered into the CRFs, either electronically by site personnel or through paper CRFs.
Data Validation: CDM teams implement validation checks to ensure data quality and consistency. Data validation checks may include range checks, consistency checks, and logic checks.
Query Management: Queries are generated when data discrepancies or inconsistencies are identified. CDM teams send queries to investigational sites for resolution.
Data Cleaning and Quality Control:
Data Cleaning: Data are cleaned to resolve discrepancies, discrepancies, and inconsistencies. This involves querying data discrepancies with clinical trial sites.
Data Review: CDM teams review data to ensure completeness and accuracy, and any outstanding queries are resolved.
Quality Control: Quality control processes are applied to verify the integrity and accuracy of data.
Database Lock:
Once the data are cleaned, reviewed, and validated, the database is locked, indicating that no further changes can be made to the data. Database lock is a critical step before data analysis begins.
Data Export and Analysis:
Data is exported from the database and provided to biostatisticians and researchers for statistical analysis. This analysis is conducted to determine the study's outcomes, efficacy, and safety profile.
Data listings, summaries, and tables are generated for regulatory submissions, reports, and publications.
Final Study Reporting:
After data analysis, CDM teams contribute to the preparation of final study reports, which provide a comprehensive overview of the trial's results, data quality, and regulatory compliance.
Archiving and Documentation:
Clinical trial data, documentation, and databases are archived to ensure their long-term availability for regulatory audits and future reference.
Regulatory Submission: CDM teams provide support for regulatory submissions.
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.
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.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Clinical Data Management: Best Practices and Key ConsiderationsClinosolIndia
Clinical data management (CDM) is a critical component of clinical research, involving the collection, processing, and analysis of data generated during clinical trials. Implementing best practices and considering key considerations is essential for ensuring data quality, integrity, and regulatory compliance. Here are some important considerations and best practices in clinical data management:
Data Standardization: Standardizing data collection and documentation across study sites is crucial for ensuring consistency and facilitating data analysis. Develop standardized data collection forms, case report forms (CRFs), and electronic data capture (EDC) systems that capture relevant data elements in a consistent manner.
Data Validation and Quality Control: Implement robust data validation procedures to ensure the accuracy and completeness of collected data. Conduct thorough quality control checks, including data validation checks, range checks, and consistency checks, to identify and resolve data discrepancies or errors.
Data Security and Privacy: Ensure data security and protect participant privacy by implementing appropriate measures such as data encryption, secure data transfer protocols, access controls, and adherence to applicable data protection regulations like GDPR or HIPAA.
Data Monitoring and Cleaning: Regularly monitor data collection processes to identify and address data discrepancies, missing data, or outliers. Implement data cleaning procedures to identify and resolve data errors, inconsistencies, and outliers that may impact the integrity and reliability of the study data.
Data Traceability and Audit Trail: Maintain a comprehensive audit trail that captures all changes and activities related to data entry, data modifications, and data review. This ensures data traceability and facilitates data validation and regulatory inspections.
Standard Operating Procedures (SOPs): Develop and adhere to well-defined SOPs for data management activities. SOPs should cover all aspects of data collection, processing, validation, cleaning, and archiving, ensuring consistency and adherence to regulatory requirements.
Database Designing in Clinical Data ManagementClinosolIndia
When designing a Clinical Data Management (CDM) database, several key considerations should be taken into account to ensure efficient data capture, storage, and retrieval. Here are some important aspects to consider in CDM database design:
Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
Develop a data model that represents the structure and relationships of the data. Use standard data models, such as CDISC (Clinical Data Interchange Standards Consortium) standards, as a foundation. Define entities (e.g., patients, visits, assessments) and attributes (e.g., demographics, lab results) and establish relationships between them.
Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
Visit:www.acriindia.com
ACRI is a leading Clinical data management training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
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.
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.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Clinical Data Management: Best Practices and Key ConsiderationsClinosolIndia
Clinical data management (CDM) is a critical component of clinical research, involving the collection, processing, and analysis of data generated during clinical trials. Implementing best practices and considering key considerations is essential for ensuring data quality, integrity, and regulatory compliance. Here are some important considerations and best practices in clinical data management:
Data Standardization: Standardizing data collection and documentation across study sites is crucial for ensuring consistency and facilitating data analysis. Develop standardized data collection forms, case report forms (CRFs), and electronic data capture (EDC) systems that capture relevant data elements in a consistent manner.
Data Validation and Quality Control: Implement robust data validation procedures to ensure the accuracy and completeness of collected data. Conduct thorough quality control checks, including data validation checks, range checks, and consistency checks, to identify and resolve data discrepancies or errors.
Data Security and Privacy: Ensure data security and protect participant privacy by implementing appropriate measures such as data encryption, secure data transfer protocols, access controls, and adherence to applicable data protection regulations like GDPR or HIPAA.
Data Monitoring and Cleaning: Regularly monitor data collection processes to identify and address data discrepancies, missing data, or outliers. Implement data cleaning procedures to identify and resolve data errors, inconsistencies, and outliers that may impact the integrity and reliability of the study data.
Data Traceability and Audit Trail: Maintain a comprehensive audit trail that captures all changes and activities related to data entry, data modifications, and data review. This ensures data traceability and facilitates data validation and regulatory inspections.
Standard Operating Procedures (SOPs): Develop and adhere to well-defined SOPs for data management activities. SOPs should cover all aspects of data collection, processing, validation, cleaning, and archiving, ensuring consistency and adherence to regulatory requirements.
Database Designing in Clinical Data ManagementClinosolIndia
When designing a Clinical Data Management (CDM) database, several key considerations should be taken into account to ensure efficient data capture, storage, and retrieval. Here are some important aspects to consider in CDM database design:
Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
Develop a data model that represents the structure and relationships of the data. Use standard data models, such as CDISC (Clinical Data Interchange Standards Consortium) standards, as a foundation. Define entities (e.g., patients, visits, assessments) and attributes (e.g., demographics, lab results) and establish relationships between them.
Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
Visit:www.acriindia.com
ACRI is a leading Clinical data management training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
Definition. A clinical research protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study.
Here's a list of steps on how to write a research protocol:
Write a project summary. ...
Create a section for basic information. ...
Offer the rationale for your research study. ...
State the study's goals and objectives. ...
Detail the study design. ...
Define the methodology. ...
List safety considerations. ...
Create steps for the follow-up process.
Role of protocol in clinical research.
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analyzed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
Similar to Protocol Understanding_Katalyst HLS (20)
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
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
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
All about Clinical Trials_Katalyst HLSKatalyst HLS
Introduction to All about Clinical Trials of 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
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
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.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Telegram: bmksupplier
signal: +85264872720
threema: TUD4A6YC
You can contact me on Telegram or Threema
Communicate promptly and reply
Free of customs clearance, Double Clearance 100% pass delivery to USA, Canada, Spain, Germany, Netherland, Poland, Italy, Sweden, UK, Czech Republic, Australia, Mexico, Russia, Ukraine, Kazakhstan.Door to door service
Hot Selling Organic intermediates
3. • The protocol contains a study plan on which the clinical trial is based.
• Protocol is designed in such a way that it safeguards the health of the participants (while
limiting their financial liability) and also answer specific research questions
• Protocol lays out who, what, why, when, where, how about the clinical trial
• It safeguards clinical trial integrity
Protocol Understanding: Overview
3
Katalyst Healthcares & Life Sciences
4. After completing this chapter you will be able to:
– Understand protocol document
– Understand the contents of a protocol
– Understand the importance of protocol in clinical trials
Objectives:
4
Katalyst Healthcares & Life Sciences
5. • Protocol is a set of rules. Consider that you are driving a car. You have to follow some
set of rules while you are driving. Why are traffic rules required? These traffic rules
ensures that the transportation occurs in smooth and safe way. Similarly in Clinical
trials, the protocols were set up so that the transportation of clinical data across study
teams is smooth and safe
• CDISC is creating a standard called the Protocol Representation Model(PRM), which
identifies, defines and describes over 300 common protocol elements and maps those
elements to elements within the BRIDG model. The PRM model is intended as a
standard to be used in designing a study, selecting investigative sites, developing data
collection tools, and describing an analysis plan and study procedures
Do You Know:
5
Katalyst Healthcares & Life Sciences
6. • Amending the protocol immediately after an issue is discovered contributes
significantly to patient safety and overall success of the study
• The following practices should be followed during the design of electronic CRFs:
– The protocol should determine what data should be collected on the CRF
– All data must be collected on the CRF if specified in the protocol
Do You Know:
6
Katalyst Healthcares & Life Sciences
7. • A Clinical Trial Protocol is a document that describes the objective(s), design, methodology,
statistical considerations, and organization of a clinical trial.
- ICH-GCP Guidelines
Protocol Definition:
7
Katalyst Healthcares & Life Sciences
8. • The protocol gives the background and reason the trial is being conducted
• The protocol contains a study plan on which the clinical trial is based. The plan is designed to
safeguard the health of the participants (while limiting their financial liability) as well as answer
specific research questions
• The protocol describes, among other things, what types of people may participate in the trial;
the schedule of tests, procedures, medications, and dosages; and the length of the study
• While in a clinical trial, study participants are seen regularly by the research staff (usually
medical doctors and/or nurses) to monitor their health and to determine the safety and
effectiveness of the treatment(s) they are receiving
Protocol Overview:
8
Katalyst Healthcares & Life Sciences
9. Protocol - Cover Page:
9
Protocol Title: A randomized double blind placebo controlled study to investigate the safety of XYZ in healthy adult volunteers
Protocol Number: ABCD0001
Protocol Date: 10 October 2011
Study Phase: I
Project Leader: Jill J Jack
Protocol Author(s): A Fernandes PhD
B Neil PhD
C Frank PhD
Confidentiality Agreement
INVESTIGATOR: A Fernandes
TT Hospital
1st Floor, Ward 1A,
Delhi, India
SPONSOR: ABCL Ltd
The International Centre
Kensington SEZ,
PO Box X11, Mumbai, India
This document is a confidential communication of ABCL Ltd. Acceptance of this document constitutes the
agreement by the recipient that no unpublished information contained within will be published or disclosed
without prior written approval, except that this document may be disclosed to the appropriate Ethics
Committee and Regulatory Authority under the condition that they are requested to keep it confidential
11. 1. Background:
• Name and/or identity (i.e. chemical composition) of the investigational drug product(s) and the
disease or condition for which the investigational drug product(s) is (are) being evaluated
• Current status of the disease or condition for which the investigational drug(s) is (are) being
evaluated; to include current problems or deficiencies that warrant an evaluation of the
investigational drug
2. Rationale:
• Reason(s) why investigational drug(s) will be safe and effective for the clinical indication
• Description of, and justification for, the proposed route of administration, dosage, dosage regimen,
and duration of dosing of the investigational drug(s)
• Nature of the individuals (e.g., age range, sex, disease state or underlying condition) who will be
included in the proposed clinical evaluation of the investigational drug(s)
• If the investigational drug(s) has (have) been withdrawn from research or marketing in any country
for any reason related to its safety or effectiveness
1. Introduction:
11
Katalyst Healthcares & Life Sciences
12. 2. Clinical Study Objectives:
12
This section includes:
1. Primary objective:
• Address the primary objective and specific aim(s) of the proposed clinical evaluation of the investigational
drug(s)
• Example: To lower the blood glucose level by 20 units
2. Secondary objectives:
• Address, if applicable, secondary objective(s) and specific aim(s) of the proposed clinical
evaluation of the investigational drug(s)
• Example: To improve the quality of life
3. Endpoints: These are outcome measures used to address the objectives of a clinical trial.
• The primary endpoint is the most important outcome and is used to assess the primary objective of a trial
• Example: The variable used to compare the effect difference of two treatment groups).
Katalyst Healthcares & Life Sciences
13. • The scientific integrity of the trial and the credibility of the data from the trial depend substantially on
the trial design. This includes:
1. A specific statement of the primary endpoints and the secondary endpoints, if any, to be
measured during the trial
2. A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled,
parallel design) and a schematic diagram of trial design, procedures and stages
3. A description of the measures taken to minimize/avoid bias, including:(a) Randomization (b)
Blinding
4. A description of the trial treatment(s) and the dosage and dosage regimen of the investigational
product(s). Also include a description of the dosage form, packaging, and labeling of the
investigational product(s).
5. The expected duration of subject participation, and a description of the sequence and duration of
all trial periods, including follow-up, if any
3. Study Design:
13
Katalyst Healthcares & Life Sciences
14. 6. A description of the “stopping rules” or
“discontinuation criteria” for individual subjects, parts
of trial and entire trial
7. Accountability procedures for the investigational
product(s), including the placebo(s) and
comparator(s), if any
8. Maintenance of trial treatment randomization codes
and procedures for breaking codes
9. The identification of any data to be recorded directly
on the CRFs (i.e. no prior written or electronic record of
data), and to be considered to be source data
3. Study Design contd..
14 Katalyst Healthcares & Life Sciences
16. 1. Subject inclusion criteria
Inclusion criteria are characteristics that the prospective subjects must have if they are to be
included in the study
Example:
1. Study subjects must meet age (in years) and gender (men and women) criteria of the study
protocol.
2. Study subjects must meet disease criteria as specified by the study protocol.
2. Subject exclusion criteria
Exclusion criteria are those characteristics that disqualify prospective subjects from inclusion in
the study.
Example:
1. Study subjects must not have a medical history of sensitivity, intolerance, or toxicity to the
investigational product, or agents similar to the investigational product.
2. Study subjects must not have donated blood two months prior to study entry, and must not
donate blood after study entry until at least 30 days after the study subject has completed the
study.
4. Subject Selection:
16 Katalyst Healthcares & Life Sciences
17. 3. Subject withdrawal criteria
(i.e. terminating investigational product treatment/trial treatment) and procedures specifying:
a. When and how to withdraw subjects from the trial/ investigational product treatment
b. The type and timing of the data to be collected for withdrawn subjects
c. Whether and how subjects are to be replaced
d. The follow-up for subjects withdrawn from investigational product treatment/trial
treatment
4. Subject Selection:
17
Katalyst Healthcares & Life Sciences
18. 1. The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the
dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including
the follow-up period(s) for subjects for each investigational product treatment/trial treatment
group/arm of the trial
2. Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before
and/or during the trial
3. Procedures for monitoring subject compliance
4. Withdrawal of subjects due to non-compliance/ adherence
5. Study drug supplies:
Formulation and packaging
Preparing and dispensing
Drug administration
6. Study drug storage and accountability
7. Description of Concomitant Medications and Rescue Medications.
5. Study Drug(s):
18 Katalyst Healthcares & Life Sciences
19. 1. Screening procedures :
Description of the procedures performed at subject screening to verify subject eligibility for
study participation
2. Study drug procedures :
Description of the procedures performed for, and in association with, the administration of the
study drug(s)
3. Follow-up procedures (only if follow-up procedures will be performed)
Description of follow-up procedures that will be performed after the subject completes the study drug
administration procedures
Schedule of activities (Study Table)
A table that summarizes the clinical protocol procedures; to include the procedures that will be
performed at screening, during the study drug administration, and at follow-up (if applicable) to the
study drug administration
6. Research Study Procedures:
19 Katalyst Healthcares & Life Sciences
20. Assessment of Safety :
1. Specification of safety parameters
2. The methods and timing for assessing, recording, and analyzing
safety parameters
3. Procedures for eliciting reports of and for recording and
reporting adverse event and inter-current illnesses
4. The type and duration of the follow-up of subjects after adverse
events
7. Safety and Efficacy Assessments:
20
Katalyst Healthcares & Life Sciences
21. Assessment of Efficacy :
1. Specification of the efficacy parameters
2. Methods and timing for assessing, recording, and analyzing of efficacy parameters
7. Safety and Efficacy Assessments contd..
21
22. 1. Adverse event definitions
2. Recording/Reporting requirements :
Eliciting adverse event information
Recording requirements
3. Reporting of adverse reactions :
Reporting of adverse reactions to the FDA
Reporting adverse events to the responsible IRB
4. Withdrawal of subjects due to adverse events
8. Adverse Event Reporting:
22
23. 1. A description of the statistical methods to be employed, including timing of any planned
interim analysis
2. The number of subjects planned to be enrolled. In multicenter trials, the numbers of enrolled
subjects projected for each trial site should be specified.
3. Reason for choice of sample size, including reflections on (or calculations of) the power of the
trial and clinical justification
4. The level of significance to be used
5. Criteria for the termination of the trial
6. Procedure for accounting for missing, unused, and spurious data
7. Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s)
from the original statistical plan should be described and justified in protocol and/or in the final
report, as appropriate)
8. The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed
subjects, all eligible subjects, evaluable subjects)
9. Statistical Methods/Data Analysis:
23
24. Description of nature and timing of the quality control/quality assurance reviews
(i.e., independent of the previously described monitoring activities) that will be undertaken by the
Sponsor-Investigator to ensure appropriate conduct of the clinical research study and quality and
completeness of the accrued study data. I.e., describe the data and safety monitoring plan for
the proposed clinical research study.
10. Quality Control and Quality Assurance:
24
Katalyst Healthcares & Life Sciences
25. 1. Data recording/Case Report Forms : A Case Report Form (CRF) should be completed for each
subject enrolled into the clinical study. The Sponsor-Investigator will review, approve and
sign/date each completed CRF; the Sponsor-Investigator’s signature serving as attestation of
the Sponsor-Investigator’s responsibility for ensuring that all clinical and laboratory data
entered on the CRF are complete, accurate and authentic.
2. Record maintenance and retention : The Sponsor-Investigator will maintain records in
accordance with Good Clinical Practice guidelines.
11. Data Handling and Record-Keeping:
25
Katalyst Healthcares & Life Sciences
26. 1. Institutional Review Board (IRB) approval
2. Ethical and scientific conduct of the clinical research study
3. Subject informed consent
12. Ethics:
26
Katalyst Healthcares & Life Sciences
27. • Discontinuation of individual research subjects : Addresses any discontinuation criteria or
“stopping rules” for individual research subjects that were not addressed previously under
section 5.1.1 (Withdrawal of subjects due to non-compliance/adherence) or section 8.4
(Withdrawal of subjects due to adverse events) of the clinical protocol.
• Sponsor-Investigator discontinuation of the clinical research study : Describes the
discontinuation criteria or “stopping rules” for parts of the clinical research study, if applicable,
or for the entire clinical research study.
13. Study Discontinuation Criteria:
27
Katalyst Healthcares & Life Sciences
28. • Lets see how does a protocol look like :
Lets discuss:
28
Katalyst Healthcares & Life Sciences
29. 1. Define Protocol?
2. Which section of protocol describes procedures for monitoring subject compliance ?
3. Fill in the blank: The Sponsor-Investigator will maintain records in accordance with
________________
4. Procedures for reporting any deviation(s) from the original statistical plan described and
justified in __________and/or in the final report, as appropriate)
Test Your Understanding:
29
Katalyst Healthcares & Life Sciences
30. In this session the following topics were covered:
• Introduction to Clinical study protocol
• Contents of a protocol
• Importance of protocol in clinical trials
Summary:
30
Katalyst Healthcares & Life Sciences
31. You have successfully completed -
Protocol Understanding
Summary:
31
Katalyst Healthcares & Life Sciences