Protocol Deviation Handling

Slides:



Advertisements
Similar presentations
Micro Control Solutions Stability System II rev. 6.4
Advertisements

Chicken Soup for the Busy Coordinator
Enterprise Portal Training
Capture of Audit & non-conformances for your mobile workforce Solution.
Clinical Research Importance of resume. Resume The first impression And maybe the last too….
Patient Portal Templates. Click on Templates. While logged in as a Delegate,
Next Throughout this demo, if nothing happens for a couple of seconds click ‘Next’ to continue … SCI Gateway Product Demonstration Updated next.
A Blueprint For Clinical Research: Standard Operating Procedures
Managing Sponsorship Research Services University of Oxford.
Neurological Emergencies Treatment Trials Network RAMPART This award is funded with support of NINDS, BARDA and the NIH CounterACT program.
IBS Global Customer Support LOGGING CALLS WITH IBS SERVICE DESK.
Richard M. Amano, Principal Chemist Laboratory Data Consultants, Inc.
Measures of dispersion Standard deviation (from the mean) ready.
Regulatory Overview.
Module J Audits and Inspections Patricia E. Koziol 1Module J Final Version 1-May-2010.
Role of the Oncology Research Team Carmen B. Jacobs, RN, OCN, CCRP.
CDG is a simple to use application that allows you to convert CSV files in to Pdfs, based on predefined MS word format based templates. Know-How Using.
6/1/09.
Registering a systematic review on PROSPERO. PROSPERO: International prospective register of systematic reviews Web based Free to register Free to search.
PREPARATION FOR A MONITORING VISIT KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008.
Essential Documents and Regulatory Files Lack of planning can constitute an emergency Rachel Sheppard Regulatory Director, OCRSS.
Chapter 3 Operation Course T314.
Project Management Workshop Carmen B. Jacobs, RN,OCN, CCRP Office of Multicenter Clinical Research.
Printing Completion Certificates of other viewers TUTORIAL
LOAN RADAR Media Center, LLC. Keep your team on the same page Update your in-process loans with loan status.
NEEDS ASSESSMENT. The purpose of the needs assessment is to determine “why” gaps based on data exist by conducting a root cause analysis. Data AnalysisNeeds.
4 Starting Tips to Keep Your Car in Top Condition
BUS 475 Week 4 Learning Team Communication Plan Outline Develop a generic communications plan and template. This template will be used to develop a communication.
BSHS 401 Week 5 Individual Documenting and Monitoring Check this A+ tutorial guideline at 401/BSHS-401-Week-5-Individual-
Reportable Events Emory IRB 9/11/2014.
THE UNTOLD STORY: MONITORING MECHANISMS
MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS
INDUSTRIAL HYGIENE Conduct Industrial Hygiene Risk Assessments and log, communicate and analyze IH Monitoring results Catalog & assess site projects &
Good Clinical Practice
Team 1: 32 responses Team 2: 55 responses Team 3: 29 responses
Crystal Template - Trial Version.
COMMUNICATION.
(Includes setup) FAQ ON DOCUMENTS (Includes setup)
Infrastructural Support – Enabling CTS
eDIRECT: Managing Test Sessions
عمل الطالبة : هايدى محمد عبد المنعم حسين
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
A3 Project Title Project Lead: Facilitator: Project Champion(s):
Clinical Program Manager
8th Continual Improvement & Innovation Symposium 2016 CASE STUDY COMPETITION: KAIZEN TEMPLATE [ Name of the company ] [ Department / Section ] [ Kaizen.
افسردگی شناخت، ارزیابی، و پیشگیری در جمعیت دانشجویی
افسردگی شناخت، ارزیابی، و پیشگیری در جمعیت دانشجویی
Quality Control SOP 3.12 Release Date: 08/10/2015.
فرایند تسهیلگری در مددکاری جامعه ای
Nat. Rev. Cardiol. doi: /nrcardio
Why PTW (SIMOP) monitor?
Why JHA monitor? Knowing what should be done for: Job Hazard Analysis
New NIH Human Subjects & Clinical Trials Information
Larix – a full service Clinical Research Organisation
PD Capacity Design Studio Check In
MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS
Monitoring Reports that Assist with Remote Monitoring
The Continuous Improvement Process
Good Clinical Practice in Research
University of Kentucky E-IRB
Protocol Registration Manual (version 3.0, April 2015) Essential Documents Appendix (version 2.0, 20/Dec/2006)
Patient Instructions and Consents
Ravanello Management Operating System
EM Phases Conference Prague Oct 2018
2 MINUTE PEARLS Check Out Function
SOP of Installing the Drivers
Sample Management Operating System
7th Continual Improvement & Innovation Symposium 2015 CASE STUDY COMPETITION: KAIZEN TEMPLATE [ Name of the company ] [ Department / Section ] [ Kaizen.
Protocol Approval Criteria
Presentation transcript:

Protocol Deviation Handling Omar Hamidi, Clinical Project Data Manager

Protocol Deviation Handling Process Define list of important PDs Identify, classify and document PDs Process PDs Review and update Root cause analysis, if applicable Trending

Protocol Deviation Handling Define list of important PDs Trial-specific list Template from SOP Defined by clinical trial team

Protocol Deviation Handling Identify, classify and document PDs Monitor identifies PDs Automatic checks identify potential PDs PDs identified by others are communicated to monitor Classify as important or non-important Document in PD log

Protocol Deviation Handling

Protocol Deviation Handling Auto Monitor Auto

Protocol Deviation Handling Process PDs Process PDs Review and update Root cause analysis, if applicable Trending

Protocol Deviation Handling Trial Manager

Protocol Deviation Handling Process PDs Print Individual – PDF Complete log - Excel

Protocol Deviation Handling Process PDs - Trending

Protocol Deviation Handling Process PDs - Trending

Feedback: Privacy Policy Feedback
Do Not Sell My Personal Information
About project: SlidePlayer Terms of Service

© 2025 SlidePlayer.com. Inc. All rights reserved.