Roles And Responsibilities Of Monitor

•Download as PPT, PDF•

16 likes•7,574 views

The monitor oversees clinical trials on behalf of the sponsor to ensure trials are conducted according to regulations. The monitor's responsibilities include ensuring informed consent is obtained properly, investigational products are stored and distributed correctly, only eligible subjects are enrolled, accurate source documents are maintained, and case report forms are complete. The monitor submits written reports to the sponsor summarizing site visits, findings, and any issues requiring action.

Business Technology

ROLES AND RESPONSIBILITIES OF MONITOR By: Lekshmi.L.Nair

Define Monitor ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Responsibilities of Monitor ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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

Sponsor Responsibilities ppt

Santosh Zarkariya

Essential documents

Rajeev Sahai

Clinical trial monitoring

Dr. Ashish singh parihar

A Clinical Research Coordinator (CRC) is a healthcare professional who plays a crucial role in the execution and management of clinical research studies. The CRC acts as a liaison between the study sponsor, principal investigator (PI), study participants, and other members of the research team. Their primary responsibility is to ensure the smooth conduct of clinical trials and adherence to protocol requirements. Here are some key responsibilities of a Clinical Research Coordinator

Audits & Inspections in Clinical Research

Jobin Kunjumon Vilapurathuu

Cra responsebility

Dr. Ashish singh parihar

Site & investigator selectionMukesh Jaiswal

Sponsor's Role and Responsibilities

HSK College of Pharmacy

ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS

jyothibhat21

Audit and Inspection in Clinical Trial

DR. RANJEET PRASAD

CRA/ Monitor Roles and Responsibilities

www.CLINIINDIA.com .

Designing of clinical study protocol rumana hameed

Rumana Hameed

Site qualification visit

Vinendrasinh Parmar

ICH GCP GUIDELINES FOR CONDUCT OF TRIAL

MOHAMMED FAHEEM KHAN

Advesre drug reaction- Types, Reporting, Evaluation, Monitoring, Preventing &...

Suhas Reddy C

manon-labrecque-cv-2012manon_artiste

What's hot

Roles and Responsibilities of sponsor, CRO, and investigator

MOHAMMEDSALEEMJM

How to report an SAEDr. Shweta Bhatia

Monitoring and auditing in clinical trialsJyotsna Kapoor

Drug accountability

Upendra Agarwal

Role and responsibilities of investigators as per ich

Maniz Joshi

Investigator Role and Responsibilities

HSK College of Pharmacy

Case report form and application

Irene Vadakkan

procurement and storage of investigation product

farmanadeeb

Preparation of Clinical Trial Protocol of India.

Aakashdeep Raval

Clinical Research Coordinator

ClinosolIndia

Audits & Inspections in Clinical Research

Jobin Kunjumon Vilapurathuu

Cra responsebility

Dr. Ashish singh parihar

Site & investigator selectionMukesh Jaiswal

Sponsor's Role and Responsibilities

HSK College of Pharmacy

ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS

jyothibhat21

Audit and Inspection in Clinical Trial

DR. RANJEET PRASAD

CRA/ Monitor Roles and Responsibilities

www.CLINIINDIA.com .

Designing of clinical study protocol rumana hameed

Rumana Hameed

Site qualification visit

Vinendrasinh Parmar

ICH GCP GUIDELINES FOR CONDUCT OF TRIAL

MOHAMMED FAHEEM KHAN

What's hot (20)

Roles and Responsibilities of sponsor, CRO, and investigator

How to report an SAE

Monitoring and auditing in clinical trials

Drug accountability

Role and responsibilities of investigators as per ich

Investigator Role and Responsibilities

Case report form and application

procurement and storage of investigation product

Preparation of Clinical Trial Protocol of India.

Clinical Research Coordinator

Audits & Inspections in Clinical Research

Cra responsebility

Site & investigator selection

Sponsor's Role and Responsibilities

ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS

Audit and Inspection in Clinical Trial

CRA/ Monitor Roles and Responsibilities

Designing of clinical study protocol rumana hameed

Site qualification visit

ICH GCP GUIDELINES FOR CONDUCT OF TRIAL

Viewers also liked

Advesre drug reaction- Types, Reporting, Evaluation, Monitoring, Preventing &...

Suhas Reddy C

manon-labrecque-cv-2012manon_artiste

Chronopharmacology Dr Mangala

Dr Mangala Nischal

Auditor roles & responsibilities in CT as per ICHGCP

Suhas Reddy C

Chronopharmacology basic concepts

swanandpathak

Second page of digi pack analysis

shaniceA

ChronopharmacologyASHUTOSH MISHRA

stress in nursing

Khai ho

Battle for the biosphere pp

Mrs Coles

Catering Services in a Hospital

Sameer Shinde

The AWS Shared Security Responsibility Model in Practice

Amazon Web Services

Step by Step Guide to Holy Hajj /Haj

Tanveer Padder

• This is a simple, compact and concise presentation for Holy Hajj. • This can be easily printed or downloaded to your computer, laptop, notebook, I pad, I Phone or any other device • This would be of great help to people planning or going for Hajj. • Please feel free to download this presentation and share with friends and family. • May Allah accept your Hajj. • Please remember me and my family in your prayers

R visualization: ggplot2, googlevis, plotly, igraph Overview

Olga Scrivner

Viewers also liked (13)

Advesre drug reaction- Types, Reporting, Evaluation, Monitoring, Preventing &...

manon-labrecque-cv-2012

Chronopharmacology Dr Mangala

Auditor roles & responsibilities in CT as per ICHGCP

Chronopharmacology basic concepts

Second page of digi pack analysis

Chronopharmacology

stress in nursing

Battle for the biosphere pp

Catering Services in a Hospital

The AWS Shared Security Responsibility Model in Practice

Step by Step Guide to Holy Hajj /Haj

R visualization: ggplot2, googlevis, plotly, igraph Overview

Similar to Roles And Responsibilities Of Monitor

ICHGCP Guidelines overview

Vidhya priya

Investigators Responsibilities during Clinical trials

BHAVYARAJAN2

ICH GCP

Suman Baishnab

ich gcp

kalpeshmanoharkapure

roles and responsibilities of Investigator[663]

Integral university, Lucknow

Investigators Responsibilities

ClinosolIndia

Good Clinical Practice

Med Bee

ICH GCP.ppt

ssuserc31da8

ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES

DR. RANJEET PRASAD

Assignment on Regulatory Prespectives of Clinical Trials

Deepak Kumar

4.1.2 investigator.pptx

SyedaErum5

Roles and responsibilities of investigator

Pavani555

Ich e6(r1)

ManishaChauhan86

Manisha ppt

manisha verma

CRP ppt Aadil.pptx

SiddharthShekharSing4

Good clinicalpractices final with links 090924111337-phpapp01Krishnendu Ray

Good Clinical Practices (Final With Links)

guesta8ff9d

Quality Assurance : Audit And Inspectionprashanth

Ich gcp

Khushbu Shah

Suzanne Pozsonyi MedicReS World Congress 2013

MedicReS

Similar to Roles And Responsibilities Of Monitor (20)

ICHGCP Guidelines overview

Investigators Responsibilities during Clinical trials

ICH GCP

ich gcp

roles and responsibilities of Investigator[663]

Investigators Responsibilities

Good Clinical Practice

ICH GCP.ppt

ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES

Assignment on Regulatory Prespectives of Clinical Trials

4.1.2 investigator.pptx

Roles and responsibilities of investigator

Ich e6(r1)

Manisha ppt

CRP ppt Aadil.pptx

Good clinicalpractices final with links 090924111337-phpapp01

Good Clinical Practices (Final With Links)

Quality Assurance : Audit And Inspection

Ich gcp

Suzanne Pozsonyi MedicReS World Congress 2013

Recently uploaded

Enterprise Excellence is Inclusive Excellence.pdf

KaiNexus

Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion. What is Enterprise Excellence? Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization. What might I learn? A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo. Who might benefit? Anyone and everyone leading folks from the shop floor to top floor. Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.

Digital Transformation and IT Strategy Toolkit and Templates

Aurelien Domont, MBA

This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy. Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com

Meas_Dylan_DMBS_PB1_2024-05XX_Revised.pdf

dylandmeas

Unveiling the Secrets How Does Generative AI Work.pdf

Sam H

At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.

Skye Residences | Extended Stay Residences Near Toronto Airport

marketingjdass

Experience unparalleled EXTENDED STAY and comfort at Skye Residences located just minutes from Toronto Airport. Discover sophisticated accommodations tailored for discerning travelers. Website Link : https://skyeresidences.com/ https://skyeresidences.com/about-us/ https://skyeresidences.com/gallery/ https://skyeresidences.com/rooms/ https://skyeresidences.com/near-by-attractions/ https://skyeresidences.com/commute/ https://skyeresidences.com/contact/ https://skyeresidences.com/queen-suite-with-sofa-bed/ https://skyeresidences.com/queen-suite-with-sofa-bed-and-balcony/ https://skyeresidences.com/queen-suite-with-sofa-bed-accessible/ https://skyeresidences.com/2-bedroom-deluxe-queen-suite-with-sofa-bed/ https://skyeresidences.com/2-bedroom-deluxe-king-queen-suite-with-sofa-bed/ https://skyeresidences.com/2-bedroom-deluxe-queen-suite-with-sofa-bed-accessible/ #Skye Residences Etobicoke, #Skye Residences Near Toronto Airport, #Skye Residences Toronto, #Skye Hotel Toronto, #Skye Hotel Near Toronto Airport, #Hotel Near Toronto Airport, #Near Toronto Airport Accommodation, #Suites Near Toronto Airport, #Etobicoke Suites Near Airport, #Hotel Near Toronto Pearson International Airport, #Toronto Airport Suite Rentals, #Pearson Airport Hotel Suites

Business Valuation Principles for Entrepreneurs

Ben Wann

Exploring Patterns of Connection with Social Dreaming

Nicola Wreford-Howard

The effects of customers service quality and online reviews on customer loyal...

balatucanapplelovely

The Influence of Marketing Strategy and Market Competition on Business Perfor...

Adam Smith

What is the TDS Return Filing Due Date for FY 2024-25.pdf

seoforlegalpillers

It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.

Sustainability: Balancing the Environment, Equity & Economy

Operational Excellence Consulting

[Note: This is a partial preview. To download this presentation, visit: https://www.oeconsulting.com.sg/training-presentations] Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit. Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability. LEARNING OBJECTIVES 1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments. 2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts. 3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations. CONTENTS 1. Introduction and Key Concepts of Sustainability 2. Principles and Practices of Sustainability 3. Measures and Reporting in Sustainability 4. Sustainability Implementation & Best Practices To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations

RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...

BBPMedia1

Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.

20240425_ TJ Communications Credentials_compressed.pdf

tjcomstrang

"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬" 𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions. 𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc. Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging ⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬: ➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH ➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH ➢FreenBecky 1st Fan Meeting in Vietnam ➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS ➢ WOW K-Music Festival 2023 ➢ Winner [CROSS] Tour in HCM ➢ Super Show 9 in HCM with Super Junior ➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival ➢ Korean Vietnam Partnership - Fair with LG ➢ Korean President visits Samsung Electronics R&D Center ➢ Vietnam Food Expo with Lotte Wellfood "𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."

falcon-invoice-discounting-a-premier-platform-for-investors-in-india

Falcon Invoice Discounting

Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.

Buy Verified PayPal Account | Buy Google 5 Star Reviews

usawebmarket

Buy Verified PayPal Account Looking to buy verified PayPal accounts? Discover 7 expert tips for safely purchasing a verified PayPal account in 2024. Ensure security and reliability for your transactions. PayPal Services Features- 🟢 Email Access 🟢 Bank Added 🟢 Card Verified 🟢 Full SSN Provided 🟢 Phone Number Access 🟢 Driving License Copy 🟢 Fasted Delivery Client Satisfaction is Our First priority. Our services is very appropriate to buy. We assume that the first-rate way to purchase our offerings is to order on the website. If you have any worry in our cooperation usually You can order us on Skype or Telegram. 24/7 Hours Reply/Please Contact usawebmarketEmail: support@usawebmarket.com Skype: usawebmarket Telegram: @usawebmarket WhatsApp: +1‪(218) 203-5951‬ USA WEB MARKET is the Best Verified PayPal, Payoneer, Cash App, Skrill, Neteller, Stripe Account and SEO, SMM Service provider.100%Satisfection granted.100% replacement Granted.

ModelingMarketingStrategiesMKS.CollumbiaUniversitypdf

fisherameliaisabella

Introduction to Amazon company 111111111111

zoyaansari11365

ikea_woodgreen_petscharity_cat-alogue_digital.pdf

agatadrynko

Cracking the Workplace Discipline Code Main.pptx

Workforce Group

Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations. Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration. Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures. In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn • Four (4) workplace discipline methods you should consider • The best and most practical approach to implementing workplace discipline. • Three (3) key tips to maintain a disciplined workplace.

RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...

BBPMedia1

Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers. Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.

Recently uploaded (20)

Enterprise Excellence is Inclusive Excellence.pdf

Digital Transformation and IT Strategy Toolkit and Templates

Meas_Dylan_DMBS_PB1_2024-05XX_Revised.pdf

Unveiling the Secrets How Does Generative AI Work.pdf

Skye Residences | Extended Stay Residences Near Toronto Airport

Business Valuation Principles for Entrepreneurs

Exploring Patterns of Connection with Social Dreaming

The effects of customers service quality and online reviews on customer loyal...

The Influence of Marketing Strategy and Market Competition on Business Perfor...

What is the TDS Return Filing Due Date for FY 2024-25.pdf

Sustainability: Balancing the Environment, Equity & Economy

RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...

20240425_ TJ Communications Credentials_compressed.pdf

falcon-invoice-discounting-a-premier-platform-for-investors-in-india

Buy Verified PayPal Account | Buy Google 5 Star Reviews

ModelingMarketingStrategiesMKS.CollumbiaUniversitypdf

Introduction to Amazon company 111111111111

ikea_woodgreen_petscharity_cat-alogue_digital.pdf

Cracking the Workplace Discipline Code Main.pptx

RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...