Presentation working on clinical trialsSarah Henter
Working on Clinical Trials – Getting started
Very few clinical trials are conducted only in one country; many are available in a variety of different sites in different places, so the translation and linguistic adaptation for different target cultures and languages becomes more important – but it’s not easy to find professionals who specialize in this specific field. With my presentation I hope to provide an overview of what makes the linguistic work on clinical trials so special, what kind of texts and target audiences there are and what knowledge linguists need to acquire in order to efficiently work in this area. This is especially interesting for translators who already specialize in the medical field, but also for linguists interested in legal, business, marketing and related field who would like to add an interesting niche with high demand to their specialization.
The presentation aims to be an introduction to the characteristics and requirements of the linguistic work on texts related to clinical trials. It not only wants to give a brief overview of how clinical trials work and who the stakeholders are, but also underline the skills and knowledge set linguists who would like to further specialize in this field should acquire. It also provides them with the necessary resources to get them started. The main topics are as follows:
• Introduction to clinical trials (what are they; how do they work; who is implied)
• Types of documents used in clinical trials (medical [specialist facing/ patient facing]; legal; marketing, etc.)
• Types of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
• What skills do linguists need to work in this field?
• How to acquire that knowledge?
- Where to find glossaries/ templates/ further information
- MOOCs to take to get you started
- Books you should have read
- Other handy resources
An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
The interview question series on clinical research is important for several reasons:
Assessment of Knowledge and Experience: The series allows the interviewer to evaluate the candidate's knowledge and expertise in clinical research. By asking specific questions related to study protocols, GCP guidelines, data management, and participant safety, the interviewer can assess the candidate's depth of understanding and practical experience in the field.
Evaluation of Skills and Competencies: Clinical research requires a range of skills, such as attention to detail, problem-solving, communication, and adherence to ethical standards. Through the interview questions, the interviewer can gauge the candidate's proficiency in these areas and determine their suitability for the role.
Compliance with Regulations and Guidelines: Clinical research is governed by strict regulations and guidelines to protect the rights and safety of study participants and ensure the integrity of the data. By posing questions on GCP compliance, ethical considerations, and regulatory requirements, the interviewer can ascertain the candidate's understanding of these crucial aspects and their ability to adhere to them.
Assessment of Critical Thinking and Decision-Making: The interview questions can assess the candidate's ability to think critically and make informed decisions in various scenarios. Questions that prompt candidates to discuss challenges faced in clinical research projects and how they resolved them provide insight into their problem-solving skills and their capacity to handle real-world situations.
Presentation working on clinical trialsSarah Henter
Working on Clinical Trials – Getting started
Very few clinical trials are conducted only in one country; many are available in a variety of different sites in different places, so the translation and linguistic adaptation for different target cultures and languages becomes more important – but it’s not easy to find professionals who specialize in this specific field. With my presentation I hope to provide an overview of what makes the linguistic work on clinical trials so special, what kind of texts and target audiences there are and what knowledge linguists need to acquire in order to efficiently work in this area. This is especially interesting for translators who already specialize in the medical field, but also for linguists interested in legal, business, marketing and related field who would like to add an interesting niche with high demand to their specialization.
The presentation aims to be an introduction to the characteristics and requirements of the linguistic work on texts related to clinical trials. It not only wants to give a brief overview of how clinical trials work and who the stakeholders are, but also underline the skills and knowledge set linguists who would like to further specialize in this field should acquire. It also provides them with the necessary resources to get them started. The main topics are as follows:
• Introduction to clinical trials (what are they; how do they work; who is implied)
• Types of documents used in clinical trials (medical [specialist facing/ patient facing]; legal; marketing, etc.)
• Types of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
• What skills do linguists need to work in this field?
• How to acquire that knowledge?
- Where to find glossaries/ templates/ further information
- MOOCs to take to get you started
- Books you should have read
- Other handy resources
An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
The interview question series on clinical research is important for several reasons:
Assessment of Knowledge and Experience: The series allows the interviewer to evaluate the candidate's knowledge and expertise in clinical research. By asking specific questions related to study protocols, GCP guidelines, data management, and participant safety, the interviewer can assess the candidate's depth of understanding and practical experience in the field.
Evaluation of Skills and Competencies: Clinical research requires a range of skills, such as attention to detail, problem-solving, communication, and adherence to ethical standards. Through the interview questions, the interviewer can gauge the candidate's proficiency in these areas and determine their suitability for the role.
Compliance with Regulations and Guidelines: Clinical research is governed by strict regulations and guidelines to protect the rights and safety of study participants and ensure the integrity of the data. By posing questions on GCP compliance, ethical considerations, and regulatory requirements, the interviewer can ascertain the candidate's understanding of these crucial aspects and their ability to adhere to them.
Assessment of Critical Thinking and Decision-Making: The interview questions can assess the candidate's ability to think critically and make informed decisions in various scenarios. Questions that prompt candidates to discuss challenges faced in clinical research projects and how they resolved them provide insight into their problem-solving skills and their capacity to handle real-world situations.
NEW DRUG DEVELOPMENT
WHAT DOES DRUG MEAN?
TRADITIONAL SYSTEM OF MEDICINES
NEW DRUG DEVELOPMENT PROCESS
PHASES OF CLINICAL RESEARCH
OVERVIEW OF EACH PHASE
PHASE-0
PHASE-1
PHASE-2
PHASE-3
PHASE-4
CONSIDERATION BEFORE STARTING CLINICAL RESEARCH
AIMS AND OBJECTIVES OF EACH PHASES
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
https://www.youtube.com/watch?time_continue=4&v=F4jiJD0O8T8
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Essential Documents For the Conduct of Clinical TrialClinosolIndia
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
“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”.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
A Trial Master File (TMF) is a comprehensive collection of essential documents and records that are generated or collected during the conduct of a clinical trial. The TMF serves as the centralized repository of all study-related documentation and provides a complete and accurate account of the trial's planning, execution, and outcomes. It is an important component of Good Clinical Practice (GCP) and regulatory compliance.
NEW DRUG DEVELOPMENT
WHAT DOES DRUG MEAN?
TRADITIONAL SYSTEM OF MEDICINES
NEW DRUG DEVELOPMENT PROCESS
PHASES OF CLINICAL RESEARCH
OVERVIEW OF EACH PHASE
PHASE-0
PHASE-1
PHASE-2
PHASE-3
PHASE-4
CONSIDERATION BEFORE STARTING CLINICAL RESEARCH
AIMS AND OBJECTIVES OF EACH PHASES
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON- 9028839789
FOR ENROLLMENT IN NEXT BATCH CONTACT ON ABOVE MENTIONED NUMBER
https://www.youtube.com/watch?time_continue=4&v=F4jiJD0O8T8
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Essential Documents For the Conduct of Clinical TrialClinosolIndia
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
“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”.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
A Trial Master File (TMF) is a comprehensive collection of essential documents and records that are generated or collected during the conduct of a clinical trial. The TMF serves as the centralized repository of all study-related documentation and provides a complete and accurate account of the trial's planning, execution, and outcomes. It is an important component of Good Clinical Practice (GCP) and regulatory compliance.
SHARE Webinar: Why Should I Join a Clinical Trial with Dr. Hershmanbkling
Dr. Dawn L. Hershman of the Herbert Irving Comprehensive Cancer Center at Columbia University presented the basics of clinical trials and emphasized how important it is for more patients to participate in them. She also discussed trials currently available for early stage and metastatic breast cancers. The webinar was presented on June 25, 2014. To hear the webinar, visit www.sharecancersupport.org/hershman
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
Dr. Daniel Kaufer's live presentation made at the LBDA hosted webinar of June 15, 2016. Review additional material and event recording at www.worldeventsforum.net/lbda and lbda.org
Reasons for conducting clinical trialsJohn Douglas
To explain in simple terms, a clinical trail is a research in human volunteers to answer certain health questions. Carefully conducted clinical trails are the quickest and safest way to discover new treatment
methods that work in people and enhance their health.
A thoughtful presentation on participation in clinical trials from the Thomas Jefferson University team at the 2017 CURE OM Patient & Caregiver Symposium.
Exploring Clinical Trials: How Research Can Help Us Better Detect, Diagnose, ...Ruchi Vahi
The exploration of clinical trials has become increasingly important in the medical field, with each trial providing insight into how we can better detect, diagnose and treat diseases. In this article, we will be looking at the different aspects of clinical research and trial processes, as well as discussing the importance of these studies in advancing healthcare treatments.
Visit us: https://mprex.in/project/late-phase-clinical-trials-and-research/
Ethics and Learning Health Care: an overview of the differences between what is considered research and what is considered clinical care, and an introduction to the ethical issues that arise from this boundary being blurred.
Types Of Clinical Trials And Its Significance Clinical trials means medical research studies involving people. They are divided into different stages, called phases. The earliest phase trials might focus at whether a drug is safe or the side effects it causes. A later phase trial aims to test and compare whether a new treatment is better than existing ones.also checkwhy clinical trials are important in clinical research.
Similar to COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERVIEWS (20)
Pristyn Research Pvt Ltd is a contract research organization specialize in providing tailored clinical research and pharmaceutical development solutions to both the inventor and pharmaceutical industries. With a legacy of years of excellence, we have consistently empowered global enterprises to elevate their regulatory and clinical research endeavours, delivering impactful and high-quality data. Pristyn Research is a professional and reliable name in the pharmaceutical and research industry. We strive to produce validated medical data for research & dedicated professionals.
Our comprehensive suite of services extends beyond clinical trials and operational support. We are your one-stop destination, offering medical writing, regulatory guidance, and scientific research services. We provide a complete package, spanning the journey from drug discovery to regulatory approval, including crucial tech transfer processes. Our impressive track record boasts numerous successfully completed clinical studies and research projects, encompassing vital areas such as medical device testing. We've been instrumental in helping numerous sponsors navigate the complexities of regulatory approvals, ensuring their innovations reach the market.
Pristyn Research is a legally established corporation under the laws of India and proudly bears the registered trademark "Pristyn Research®." Notably, we have recently integrated the esteemed "Pristyn Research Solutions," a renowned leader in corporate training for research and development. Our international affiliations and regional government approvals for training programs underscore our commitment to excellence in education and development. Our vast network of representatives and affiliates spans across various sectors, including corporate, public, private organizations, and professional bodies. This expansive reach reflects our dedication to fostering collaboration and innovation within the clinical research and development domain. In summary, Pristyn is your trusted ally on the journey of scientific discovery and innovation. With a rich history of accomplishments and a forward-looking approach, we are poised to continue making significant contributions to the world of research and pharmaceuticals, consistently raising the bar for excellence.
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
COMMON REGULATORY AFFAIRS
JOB INTERVIEW QUESTIONS WITH
ANSWERS By Pristyn Research-Updated 2022.
A quick Job interview short guide For Pharma and all
Life science jobseekers.
info.pristynresearch.com
www.pristynresearch.com
9028839789 | 8999717656
All Medical | Biotech |Micro |B.Sc., M.Sc.
PAN India DRA companies
list alphabetically
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 9028839789
Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
IPLEX
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WIPRO
BIOCON
GRANULES
JUBILIANT
BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
T
BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
L RESEARCH
SRI KRISHNA
PHARMA
4C
Pharma
Solutions
These are the commonly asked questions with their answers asked in any job interviews. The file is updated in 2022.
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Sample Questions are:
Tell me about yourself?
What are your Career Goals?
Why have you been unemployed for such a long time?
Are you a team player?
Describe your management
style?
What irritates you about co
workers?
What position do you prefer
while in a team working for
project?
Do you consider yourself
successful?
what are your strengths?
what are your weaknesses?
why you left your previous job?
why we should hire you?
are you a complete fresher?
Tell me about your ability to work under pressure?
How long would you expect to work for us if hired?
What are your expectations from a job?
How do you see yourself 5 years from now?
What are your Salary Requirements?
What will you do if we reject you?
DO you have any questions for Us?
Answer it like: If selected: Yes I do, when can I join?
If rejected: Yes I do, rejection is an
opportunity to learn. I will request
you to kindly tell me the reason why I am being rejected today? I will work on my shortcomings and may one day be a part of your
organization.
What is scientific research writing?
Answer: It is the technical writing that scientists do to communicate their research to others [1].
What is a research manuscript?
Answer: A systematic inquiry document that entails collection of data; documentation of critical information; and analysis and interpretation of that data/information, in accordance with suitable methodologies set by specific professional fields and academic disciplines [2].
What is a review article?
Answer: A literature review article is a comprehensive summary of previous research on a topic. It is assumed that by mentioning a previous work in the field of study, that the author has read, evaluated, and assimiliated that work into the work at hand [3].
What is peer review paper?
The peer review paper is a validation of academic work, helps to improve the quality of published research, and increases networking possibilities within research communities [4].
What is meta-analysis?
Answer: A subset of systematic reviews; a method for systematically combining pertinent qualitative and quantitative study data from several selected studies to develop a single conclusion that has greater statistical power [5].
What dissertation?
Answer: A thesis is a hypothesis or conjecture. A PhD dissertation is a lengthy, formal document that argues in defense of a particular thesis. Two important adjectives used to describe a dissertation are ``original'' and ``substantial.'' The scientific method means starting with a hypothesis and then collecting evidence to support or deny it [6].
What are journals?
Answer: A research journal is a periodical that contains articles written by experts in a particular field of study who report the results of research in that field [7].
What does publisher mean?
Answer: Authors and publishers will generally have a publishing agreement (sometimes referred to as an author or licence agreement) in place when a work is published [8].
What is ISSN number?
Answer: An ISSN is an 8-digit code used to identify newspapers, journals, magazines and periodicals of all kinds and on all media–print and electronic [9].
What is volume of a journal?
jobs
INTERVIEW
SOFTSKILLS
BODY LANGUAGE
EYE CONTACT
POSITIVE ATTITUDE
SITTING POSTURE
SMILE
SELF CONFIDENCE
PUBLIC SPEAKING
GOOD DECISION
TIME MANAGEMENT
PUNCTUALITY
PROFESSIONALISM
RESPECT
RESPONSIBILITY
SKIN & BODY CARE
Make-up Hygiene
jobs
INTERVIEW
SOFTSKILLS
BODY LANGUAGE
EYE CONTACT
POSITIVE ATTITUDE
SITTING POSTURE
SMILE
SELF CONFIDENCE
PUBLIC SPEAKING
GOOD DECISION
TIME MANAGEMENT
PUNCTUALITY
PROFESSIONALISM
RESPECT
RESPONSIBILITY
SKIN & BODY CARE
Make-up Hygiene
SYNTHESIS, CHARACTERIZATION, AND STUDY OF ELECTRICAL
CONDUCTIVITY AND THERMOGRAVIMETRIC ANALYSIS OF
CONDUCTING POLYMER COMPOSITES WITH FLY ASH
- A Ph.D. PRE SUBMISSION SEMINAR-
Communication and Soft Skills in Pharma industry are most important to fill the vacuum created due to lack of facilities and guidance during the degree course. To prove the power of personality, Professionalism, Sovereignty, and Excellence in all walks of life for yourself and thus strengthen the shining future of your career and our Country.
NEW DRUG DEVELOPMENT
Clinical Research - Phases
New Drug Development Process
CONTENT OF INDA
CONTENT OF NDA
.
.
.
FOR MORE RELATED QUERIES CONTACT US ON 09028839789
FOR ENROLLMENT IN NEXT BATCH KINDLY CONTACT US ON THE ABOVE MENTIONED CONTACT NUMBER
http://pristynresearch.com/
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
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CLINICAL RESEARCH IS ONE WHICH MADE POSSIBLE , ORAGAN TRANSPLANT, MANAGE OF DIBETIS, ADDED YEAR OF AIDS PATIENT.
HOW WELL NEW APPROCHES AND WORK IN PEOPLE.
THE APPROACHES CAN BE MEDICAL, BEHAVIORAL, OR MANAGEMENT.
EACH STUDY ANSWER SCIENTIFIC QUESTION.
GENERAL INTRODUCTION OF CLINICAL RESEARCH
KEY POINTS AND CONCEPTUAL DEFINATION
DRUG DISCOVERY PROCESS
SOURCES OF DRUG DISCOVERY
PRECLINICAL STUDY
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Pharmaceutical Business Management:
Management is a wide ranging concept and human instinctual activity which Plans,
Organize,
Directs,
Co-Ordinates,
Controls,
Motivates and
Management As Science & Art
Development Of Management Thoughts
Contribution Of Scientist In Modern Management
Characteristics Of Management
Decides
about “use of human and other resources to attain organizational objectives.
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Scientific & systematic collection of data for clinical study is called as Clinical Data Management-
Clinical Data Management-Web Based Data Capture EDC & RDC , Oracle
SAS
Office software
UW Catalyst data collection (University of Washington)
REDCAP (Research electronic data capture)
OPENCLINICA
STUDY TRAX
Scientific & systematic collection of data for clinical study is called as Clinical data management .
EDC
RDC
HISTORY
EVOLUTION OF CLINICAL DATA CAPTURE
CRITERIA FOR IDENTIFYING AN EDC
REGULATORY GUIDELINE ON EDC
EDC ISSUES
VALIDATING ELECTRONIC SOURCE DATA
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
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This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
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Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
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Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
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COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERVIEWS
1. COMMON CLINICAL
RESEARCH JOB INTERVIEW
QUESTIONS WITH ANSWERS
info@pristynresearch.com
pristynresearch.com
By: Pristyn Research Solutions
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2. What is a clinical trial (also called clinical research)?
Definition:
Clinical research is a Branch of healthcare science & research study that involves human volunteers designed
to determine the safety and effectiveness of a drug, biologic (such as a vaccine), device (such as vagus nerve
stimulator) or other treatment or behavioral intervention.
Carefully conducted clinical trials are the fastest and safest way to find treatments that improve health in
people.
The Food and Drug Administration (FDA) requires that all new treatments be tested in clinical trials before they
are reviewed for approval. Observational trials address health issues in large groups of people in natural
settings.
Clinical research includes:
• Medical and behavioral research involving volunteer participants
• Investigations that are carefully developed and conducted with clinical outcomes recorded
• Identification of better ways to prevent, diagnose, treat, and understand human disease
• Trials that test new treatments, clinical management and clinical outcomes, and long–term studies
• Strict scientific guidelines
• Ethical principles to protect participants
3. Why participate in a clinical trial?
Because clinical trials are required of any new therapy prior to FDA approval, major improvements in healthcare
would be impossible without volunteer participants. Participants in clinical trials can play a more active role
in their own health care, gain access to new research treatments before they are widely available, and help
others by contributing to medical research.
Why is clinical Research Important (Benefits)?
Research is important because:
• Clinical trials test how well new approaches and interventions work in people
• These approaches can be medical, behavioral, or management
• Each study answers scientific questions
• Each study helps scientists prevent, screen for, diagnose, manage, and treat a disease
People who take part in clinical trials contribute to the knowledge of how a disease progresses.
Some benefits of taking part in a clinical trial are:
• Participants have access to promising new approaches often not available outside the clinical trial setting
• The drug, vaccine or other intervention being studied may be more effective and/or efficacious than the standard approach
(although there is no guarantee that participants will receive the experimental drug, vaccine, or other intervention)
• Participants receive careful medical attention from a research team of doctors and other health professionals
• Participants may be the first to benefit from the study
• Results from the study may help others in the future
4. Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a
clinical trial will vary from study to study. These criteria are based on the goals of the study and include such
factors as age, the type and stage of a disease, previous treatment history, and other medical conditions. Some research
studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.
The criteria are used to identify appropriate participants needed to answer the scientific questions being asked while keeping
them safe.
The main goal for using volunteers in a clinical trial is to prove, by scientific means, the effects and limitations of the
experimental treatment on a wide variety of people. Research procedures with volunteers are designed to develop new
knowledge, not to provide direct benefit to study participants. Before joining a clinical trial, a person must qualify for the
study:
• Some research studies seek participants with illnesses or conditions to be studied in the clinical trial
• Some research studies need volunteers who do not have the disease being studied A person with the condition being
studied is called a “patient volunteer” and:
• Has a known health problem
• Participates in research to better understand, diagnose, treat, or cure that disease or condition
• Supports research procedures to help develop new knowledge (these procedures may or may not benefit the participant)
5. A person may also volunteer who is at risk for the condition being studied. A volunteer who does
not have the condition being studied is called a “control” and:
• Participates in clinical research to test a new vaccine, microbicide, or other strategy or intervention
• Is needed when developing a new technique, such as a blood test or imaging device
• Helps define the limits of "normal"
• Serves as a control for participant groups and is often matched to participants on characteristics such as
age, gender, or family relationship
• Receives the same test, procedure, vaccine, microbicide the participant group receives Some volunteers
serve as controls by not taking the test vaccines, microbicides, or other strategies. Or these volunteers may
receive doses large enough only to show that it is present, but not at a level that can treat the condition.
Investigators learn about a disease process by comparing how each kind of volunteer reacts to the trial. Some
studies require a major commitment in time and effort. Some studies may involve some discomfort. The
research procedure may also carry some risk. The consent process for volunteers includes a detailed
discussion of the study's procedures and tests.
Purpose of Research
•Intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population.
•To test hypothesis formulated from observations and or intuition.
•Ultimately to understand better one’s world and make “Sense of it”.
7. New Drug Development Process
Research Early Development Full Development
Life Cycle
Management
Discovery
Phase
Candidate
Profiling
Phase
Preclinical
Trials
Clinical Trial
Phase I
Phase IIA Phase IIB Phase III Phase IV
CandidateSelection
Point
SelectedforProofof
Concept
Development
DecisionPoint
FullDevelopment
Point
PhaseIIICheckPoint
SubmissionDecision
Point
IND NDA
R&D
• Research Target
• Discovery of Lead
Compound
• Selection of Suitable
Candidate
Preclinical
• Lab testing
• Animal Studies
• Toxicology Studies
etc.,.
Clinical(I & II)
• Biological Tests and
Pharmacological test in
humans
• Regulatory Clearance
Clinical(III&IV)
• Registration with
Health Authorities
• Preparation for Launch
• Launch and Sales
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8. What Are Inclusion/Exclusion Criteria?
All clinical trials have guidelines about who can participate—these are specified in the inclusion/exclusion criteria:
• Factors that allow someone to participate in a clinical trial are "inclusion criteria"
• Factors that exclude or do not allow participation in a clinical trial are "exclusion criteria“
These factors may include:
• Age
• Gender
• The type and stage of a disease
• Previous treatment history
• Specific lab values
• Other medical conditions Inclusion and exclusion criteria are not used to reject people personally. The criteria are
used to:
• Identify appropriate participants
• Keep them safe
• Help ensure that researchers can answer the questions they want answered
9. What happens during a clinical trial?
The clinical trial study team, which includes doctors, nurses, and other health care professionals, checks the
health of the participant at the beginning of the trial, gives specific instructions for participating in the trial,
monitors the participant carefully during the trial, and stays in touch after the trial is completed. Some clinical trials
involve more tests and doctor visits than the participant would normally have for an illness or condition. Clinical trial
participation is most successful when the study protocol is carefully followed, including frequent contact with the clinical
trial team.
Usually, clinical trials compare a new product, vaccine, management strategy, or therapy with another that already exists.
This comparison helps to determine if the new one is as successful as, or better than, the existing one. In some studies,
participants may be assigned to receive a placebo (an inactive product that resembles the test product, but without its
treatment value). Comparing a new product with a placebo can be the fastest and most reliable way to demonstrate the
new product’s therapeutic effectiveness and/or efficacy. Placebos are not used if a participant will be put at risk (standard
of care)—particularly in the study of treatments for serious illnesses—by not having effective therapy. Potential
participants are told if placebos will be used in the study before they enter a trial. For studies using placebos:
• Clinical trial investigators must be able to show that withholding active therapy from participants for a short time is
unlikely to result in physical harm
• Participants must give voluntary, informed consent
• Investigators must closely monitor participants in these studies. For therapeutic trials, most studies compare new
products or regimens with an approved therapy (for example, standard of care).
10. Randomization is when two or more alternative treatments are assigned to volunteers by chance instead of
choice. The assigned treatment is administered with the highest level of professional care. The results of each
treatment are compared at specific points during a trial, which may last for years. When one treatment is
found superior, the trial is stopped so that the fewest participants possible receive the less beneficial
treatment. In single- or double-blind studies (also called single- or double-masked studies), participants do
not know which medicine is being used, so they can describe what happens without bias. Blind studies are
designed to prevent members of the research team or study participants from influencing the results.
Therefore, scientifically accurate conclusions are more likely. Members of the research team are not told
which participants receive which medication, so their observations will not be biased. If medically necessary,
it must always be possible to find out what participants have taken:
• In single-blind studies, only the participant is not told what is being administered
• In a double-blind study, the only person who knows what is being administered is the pharmacist
Where Do Clinical Trials Take Place?
Clinical trials take place all over the world:
• Health care providers’ offices
• Medical centers
• Community and university hospitals and clinics
• Veterans’ and military hospitals Clinical trials may include participants at one or two highly specialized centers. Or they
may Involve hundreds of locations at the same time.
11. Good Clinical Practice (GCP) is an international quality standard that governments can transpose into
regulations for clinical trials involving human subjects. GCP guidelines include protection of human rights as
a subject in clinical trial and assurance of the safety and efficacy of the newly
developed compounds. GCP guidelines also include standards on how clinical trials should be conducted
and a definition of the roles and responsibilities of clinical trial sponsors, clinical research investigators, and
monitors. Good clinical laboratory practice (GCLP) guidelines focus on good laboratory practice and good
clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing
countries
What Are Some of the Possible Risks Associated with Taking Part in a Clinical Trial?
Some risks of taking part in a clinical trial are:
• New vaccines, microbicides, and other strategies under study are not always better than the standard care to which
they are being compared
• New treatments may have unexpected side effects or risks that are worse than those resulting from standard care
• Health insurance and managed care providers may or may not cover all participant care costs in a study
• Participants may be required to make more visits to the doctor than they would if not in the clinical trial
• Participants in randomized trials are not able to choose the kind of intervention they will Receive
12. What Is the Clinical Research Process?
The clinical research process includes:
• Pre-clinical testing
• Investigational New Drug Application (IND)
• Phase I (assess safety)
• Phase II (test for effectiveness)
• Phase III (large-scale testing)
• Licensing (approval to use)
• Approval (available for prescription)
• Post-marketing studies (special studies and long-term effectiveness/use)
What Are the Elements and Principles of Clinical Research?
The elements and principles of clinical research are:
• Protocol
• Protocol review
• Sponsor
• Eligibility criteria
• Informed consent
• Types of clinical trials
• Phases of clinical trials
• Activities during clinical trials
• Clinical trial participants
(For practical work on software and other e-CTD & Industerial
internship in Research Clinical join our short –term training )
13. What Is Ethics?
Ethics means:
• Respect for persons
• Beneficence, which means to do good—in clinical research, beneficence means even more— to do no harm, or maximize
possible benefits and minimize possible harm
• Justice, or fairness Scientific research has produced many social benefits, but it has also posed some troubling
ethical questions.
Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments:
• During the Nuremberg War Crime Trials after World War II, the Nuremberg code was drafted as a set of standards for judging
physicians and scientists who had conducted biomedical experiments on prisoners. This code became the prototype of many
later codes intended to assure that research involving human subjects would be carried out in an ethical manner.15
• The Tuskegee Study of Untreated Syphilis in the Negro Male (also known as the Tuskegee Syphilis Study, Public Health Service
Syphilis Study, or the Tuskegee Experiment) was a clinical study, conducted between 1932 and 1972 in Tuskegee, Alabama by
the U.S. Public Health Service. 399 poor, mostly illiterate African Americans with syphilis were recruited for research related to
the natural progression of the disease if left untreated. The trial participants were not offered treatment for syphilis when it
became available.16
14. •Treatment of person as
autonomous
Respect for
Persons
•Potential conflict between good
of society Vs. individualBeneficence
•Treatment of all fairly and all
equally share benefits and risksJustice
3 ethical principles guide clinical research
Ethical Norms in Clinical Research
The Belmont Report17 was developed by The National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research on April 18, 1979, to:
• Summarize the basic ethical principles identified by the
Commission in the course of its deliberations
• State basic ethical principles and guidelines that should
assist in resolving the ethical problems that surround the
conduct of research with human subjects Ethical principles
must guide all research activities including:
• All phases of research, including formation of research
questions, design of the study, conduct of research, analysis
of data, and interpretation of findings
• Dissemination of new knowledge in the forms of
presentations and publications..
15. What Is a Protocol?
Example..
Clinical research is conducted according to a plan (a protocol) or action plan. The protocol acts like a “recipe”
for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why
each part of the study is necessary. The protocol or plan is carefully designed to safeguard the participants’ health and
answer specific research questions. The same protocol is used by every doctor or research center taking part in the trial. A
protocol describes:
• Who is eligible to participate in the trial
• Details about tests, procedures, medications, and dosages
• The length of the study and what information will be gathered A protocol is led by a principal investigator. The principal
investigator is often a doctor. Members of the research team regularly monitor the participants’ health to determine the
study’s safety and effectiveness and/or efficacy.
A protocol is a study plan on which each clinical trial is based. The plan is carefully designed to safeguard the health of the
participants as well as answer specific research questions. A protocol describes what types of people may participate in
the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
(For practical work on software and other e-CTD & Industrial
internship in Research Clinical join our short –term training )
16. What Is a Protocol Review?
Clinical trials in the United States must be approved and monitored by an Institutional Review Board (IRB). The
IRB ensures that the risks are minimal and are worth any potential benefits. An IRB is an independent
committee. Physicians, statisticians, and members of the community belong to an IRB. The committee ensures
that clinical trials are ethical and that the rights of all participants are protected. U.S. regulations require all
research institutions in the United States that conduct or support biomedical research involving people to
meet certain requirements. An IRB must initially approve and periodically review the research. Some research
institutions have more than one IRB. During protocol reviews, networks review and assess what other
networks are doing to see what information applies to what they are doing.
Major players in Research team
Sponsor
•Investigator
•Clinical Research Associate
•Clinical Research Coordinator
•Data Manager
•Statistician
•Patients
•IRB
•Regulatory Body
17. Major players in Research team
• Investigator
• Clinical Research Associate
• Clinical Research Coordinator
• Data Manager
• Statistician
• Patients
• IRB
• Regulatory Body
What Is a Sponsor?
Clinical trials are sponsored or funded by various organizations or individuals, including:
• Physicians
• Foundations
• Medical institutions
• Voluntary groups
• Pharmaceutical companies
• Federal agencies such as the National Institutes of Health, the Department of Defense, Centers for Disease Control and
Prevention (CDC), and the Department of Veterans Affairs Trials can occur at sites as varied as hospitals, universities,
doctors’ offices, or community clinics.
18. Principal Investigator
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of
individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal
investigator.
Investigators Qualifications
Adequacy of Resources
Medical Care of Study Participants
Communication with the IRB / IEC
Compliance with the Protocol
Investigational Product care
Responsibilities : Investigator
Records and Reports
Progress Reports
Safety Reporting
Stopping or suspending a study
Final report by investigator
Randomization & unbinding
The Informed Consent
(For practical work on software and other e-CTD & Industrial
internship in Research Clinical join our short –term training )
19. CRC
•Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between
investigative site and sponsor, and reviews all data and records before a monitor’s visit.
•Functions as extension of Investigator.
•Involved in operational duties – recruiting, scheduling, completing CRF’s, administering tests.
www.
CRA (Monitor)
•A person appointed by the Sponsor or Contract Research Organisation (CRO) for monitoring and reporting the
progress of the trial and for verification of data.
•The monitor ensures that the trial is conducted, recorded and reported in accordance with the Protocol, Standard
Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements.
Responsibilities: Monitor
•Main line of communication between sponsor and site
•Site feasibility Training and support
•to site staff & selection
•Protocol & GCP Compliance
•Document completeness & maintenance
•Source Data Verification
•Trial material accounting
•Monitoring reports & other office documentations
•Prepare and assist in IRB, Regulatory and internal audit or
inspection
•Assist in IRB and Regulatory Submission
•Assist in IRB and Regulatory Submission
• Ensure timely AE & SAE reporting
20. What Is Informed Consent?
Informed consent is the process of providing potential participants with important facts about a clinical trial
before they decide to participate. The process of informed consent, which means “providing additional
information,” continues throughout the study. Members of the research team explain the details of the study.
This explanation helps people make a decision that is right for them. Informed consent is not a contract or just
a piece of paper—it is a process.
Informed consent must be provided:
• In the participants’ native language
• At an appropriate educational level Translation or interpretive assistance can be provided for participants with limited
language skills.
The research team provides an informed consent document that includes details about the study:
• Its purpose
• Duration
• Required procedures
• Who to contact for more information
• An explanation of risks and potential benefits The participant then decides whether to sign the document
In many communities, illiteracy and mistrust exist toward anyone who asks for a signature as a commitment. Sometimes
people fear their signatures may lead to unexpected obligations, because they attach great importance to legal formalities.
Volunteers are free to withdraw from a study completely or to refuse particular treatments or tests at any time (sometimes,
however, this will make them ineligible to continue the study). Notes
21. Study Start Up
Protocol Level Feasibility
Investigator Selection Process
Conducting Pre Study Visits
Investigators Meeting
Site Initiation
Site Monitoring
Study Close out
Site Startup
Study Conduct
Study Completion
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COMMUNITY ADVISORY
BOARDS (CABS) AND
THE RESEARCH PROCESS
and IRB….
Feasibility Studies
•Protocol feasibility: To assess from the
region(s)/country(ies) where the clinical study is to be
conducted, agreement on important study criteria like
inclusion exclusion criteria, comparator drug, and study
procedures outlined in the Protocol Synopsis, to prevent the
need for protocol amendments later in the planning process
•A secondary objective is to provide information to support
finalization of the country/region allocation
Site feasibility: involves assessing site potential based on
multivariate factors like Principal Investigators experience &
interest in Clinical Research, patient inflow, accessibility to
the site, availability of patients that meet the study criteria,
and other related factors that affect the accrual rates and
proper conduct of study related activities.
•This is done to ensure that appropriate sites/Principal
Investigators are identified
22. Site Selection
•It can be defined as a systematic planned process to evaluate and select an investigator and site for conduct of
clinical trial
•Factors involved in selection
–Reputation in field
–Facilities desirable for trial conduct
–Access to patient population
–Accessible geographic location
–Anticipated time for initiation and completion of trial
–EC–ability to process protocols fairly and expeditiously
Investigator Meeting
•Purpose
–Achieve uniformity in approach by all investigators
–Review and discuss the protocol
–Answer questions
–Generate enthusiasm
–Get everyone to know each other and develop a sense of teamwork and trust
–Review potential difficulties, issues and problems
–Review administrative ground rules
www
–Relationship with sponsor
–Budgetary factors
–Past experience
–Experienced staff
23. Site Initiation
•Study initiation is done to review protocol, processes and procedures to ensure that all site personnel
understand requirements of trial
•Sites are initiated after all regulatory & ethical documentation is complete, after IP and other supplies are
shipped and before any patients are enrolled
Monitoring
•Purpose
•To verify
– protection of rights and well-being of subjects
–reported trial data is accurate, complete, and verifiable
–trial is in compliance with:
–Protocol and amendments
–Regulatory requirements
–Enrolment
–Drug supply
www
24. • All After ensuring the study is complete
• CRF received
• All study material is accounted for
• All investigational product is accounted for and balance returned to sponsor
• Ensure payment completion
Study Close Out
Start Up
•Delegate responsibilities
•Educate research team
•Enrollment plan
•Study documents
Conduct
•Protocol compliance
•Documentation
•Record retention
•Trial drug accountability
•Safety reporting
Close Out
•Final drug accountability
•Preparation of records
for archiving
•Storage or destruction of
lab samples
•Data query resolution
•Notification to governing
regulatory body
Key Issues
25. Site Management
A structured & planned approach to manage various
research activities/functions at a site to ensure
execution through compliance and strict adherence to
safety standards -through periodic monitoring per pre-
determined/planned monitoring plan.
Design
Feasibility
Study Start
up
Execution
Follow up
Close out Reporting
Publication
Study Documents
• Investigator’s Boucher
• Protocol
• Informed Consent Form
• Case Report Form
• Financial Disclosure Form
• EC Approval Letter
• Clinical Trial Agreements and Budget
• Lab Normal Ranges
• Sample Labels
• Pre trial Monitoring Report
• Signed Agreements between 2 parties.
26. Process Flow
Proposal of
study
Ethics, Feasibility
significance
Study Protocol
Pre-study planning
(Personnel, Other
resources, EC
approvals etc.,)
Agreements
Investigators
meeting, practical
planning, training
Conduct of study: Recruitment
of the participants, Informed
consent, Clinical examinations,
Specimen collection, Dispatch,
Documentation
Monitoring
Central Lab
Data analysis
Correction
Queries
Close the data,
dispatch of the
data archiving
Closing
meeting,
Evaluation of
the study
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