Clinical Data Management CDM Training

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Clinical Data Management CDM Training


 (4.9) | 750 Ratings


Introduction


Clinical Data Management CDM Training Details
Track Regular Track Weekend Track Fast Track
Course Duration 30 Hrs 8 Weekends 5 Days
Hours 1hr/day 2 Hours a day 6 Hours a day
Training Mode Online Classroom Online Classroom Online Classroom
Delivery Instructor Led-Live Instructor Led-Live Instructor Led-Live


Course Curriculum

Clinical Data Management CDM Modules

Day-1: Topic name? Drug discovery and Clinical Trial

Description: (what student can learn after Day 1?) After day 1 you will be able to understand Definition of Drug Life Cycle of a Drug Basics of Drug discovery Evolution of Clinical trials Introduction to Clinical Trials Pre-clinical Studies Investigational New Drug Phases of Clinical Trial New Drug Application

Day-2: Topic name? ICH-GCP

Description: (what student can learn after Day 2?) After day 2 you will be able to understand Definition History Evolution Structure ICH Guidelines ICH-GCP Components ICH-GCP Sections Principles of ICH-GCP Essential Documents for trial

Day-3: Topic name? Overview of Clinical Data Management

Description: (what student can learn after Day 3?) After day 3 you will be able to understand Importance of CDM Overview of Clinical Data Management Process flow of data management activities Activities performed during the course of a trial

Day-4: Topic name? Management Planning

Description: (what student can learn after Day 4?) After day 4 you will be able to understand Data Capture Study Setup Data Entry Data Transfer Data Processing/ Management Coding Bioanalytical Data Safety Data (Serious Adverse Events) Archival of Clinical Data Reports Quality

Day-5: Topic name? DM Activities in Study Set up

Description: (what student can learn after Day 5?) After day 5 you will be able to understand CRF designing Paper based and Non paper based

Day-6: Topic name? DM Database designing

Description: (what student can learn after Day 6?) After day 6 you will be able to understand Visit Structure Branching

Day-7: Topic name? Programming Procedures

Description: (what student can learn after Day 7?) After day 7 you will be able to understand Type of procedures How to write procedures

Day-8: Topic name? Database Testing

Description: (what student can learn after Day 8?) After day 8 you will be able to understand Type of Testing Page testing Database testing Procedure testing Reports testing

Day-9: Topic name? Data Entry

Description: (what student can learn after Day 9?) After day 9 you will be able to understand Documents for data entry Type of entry Data Loading Data testing

Day-10: Topic name? Vendor Data

Description: (what student can learn after Day 10?) After day 10 you will be able to understand Documents for Vendor data entry Type of Vendor data Understand the need and significance of Laboratory data generated in clinical trial Understand the types of Laboratory used in Clinical Trial Identify the required Data from Lab

Day-11: Topic name? Coding

Description: (what student can learn after Day 11?) After day 11 you will be able to understand Understand the need for coding Understand the process for coding of clinical research data Identify the terms that are required to be coded Relate the coding terms and information data that is captured in an effective and consistent manner to facilitate meaningful interpretation

Day-12: Topic name? Discrepancy Management

Description: (what student can learn after Day 12?) After day 12 you will be able to understand The process of Discrepancy Management

Day-13: Topic name? Query Writing

Description: (what student can learn after Day 13?) After day 13 you will be able to understand Session on query writing

Day-14: Topic name? Safety Data Management

Description: (what student can learn after Day 14?) After day 14 you will be able to understand Understand the safety data involved in clinical trials Importance of Safety data The processes involved in management of Safety Data

Day-15: Topic name? Reporting in Data Management

Description: (what student can learn after Day 15?) After day 15 you will be able to understand Definitions Raw Data SDTM Derived Datasets Quality Check (QC) / Peer Review Generation of Reports Creation of reports E-Publishing

Day-16: Topic name? Pre DB Lock Activities

Description: (what student can learn after Day 16?) After day 16 you will be able to understand Introduction to Database Lock Consistency Checks for Critical modules

Day-17: Topic name? QA and QC in DM

Description: (what student can learn after Day 17?) After day 17 you will be able to understand Understand the requirement to be audit/ inspection ready, procedures to be followed and role and responsibilities of team members To introduce the quality management process and key quality management activities To understand the basic concept of Quality Management

Day-18: Topic name? QA and QC in DM

Description: (what student can learn after Day 18?) After day 18 you will be able to understand Understand the definition of Audit and Inspection Understand difference between Audit and Inspection Understand the purpose of an Audit

Day-19: Topic name? QA and QC in DM

Description: (what student can learn after Day 19?) After day 19 you will be able to understand Locking Definition Unlocking definition Steps to Unlocking

Day-20: Topic name? QA and QC in DM

Description: (what student can learn after Day 20?) After day 20 you will be able to understand DEFINITIONS:  What are SOPs? Objectives Necessity Non-Compliance with SOPs Additional Benefits Note: repeat this until last day of your Course

Project Classes

Day-1: project content? Description: (what student can learn after Day 1?) Day-2: project content? Description: (what student can learn after Day 2?) Day-3: project content? Description: (what student can learn after Day 3?) Day-4: project content? Description: (what student can learn after Day 4?) Note: repeat this until last day of yourProject. How you help to the Student to build the resume? How you will prepare them for the Interview?

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Course Curriculum

Clinical Data Management CDM Modules

Day-1: Topic name? Drug discovery and Clinical Trial

Description: (what student can learn after Day 1?) After day 1 you will be able to understand Definition of Drug Life Cycle of a Drug Basics of Drug discovery Evolution of Clinical trials Introduction to Clinical Trials Pre-clinical Studies Investigational New Drug Phases of Clinical Trial New Drug Application

Day-2: Topic name? ICH-GCP

Description: (what student can learn after Day 2?) After day 2 you will be able to understand Definition History Evolution Structure ICH Guidelines ICH-GCP Components ICH-GCP Sections Principles of ICH-GCP Essential Documents for trial

Day-3: Topic name? Overview of Clinical Data Management

Description: (what student can learn after Day 3?) After day 3 you will be able to understand Importance of CDM Overview of Clinical Data Management Process flow of data management activities Activities performed during the course of a trial

Day-4: Topic name? Management Planning

Description: (what student can learn after Day 4?) After day 4 you will be able to understand Data Capture Study Setup Data Entry Data Transfer Data Processing/ Management Coding Bioanalytical Data Safety Data (Serious Adverse Events) Archival of Clinical Data Reports Quality

Day-5: Topic name? DM Activities in Study Set up

Description: (what student can learn after Day 5?) After day 5 you will be able to understand CRF designing Paper based and Non paper based

Day-6: Topic name? DM Database designing

Description: (what student can learn after Day 6?) After day 6 you will be able to understand Visit Structure Branching

Day-7: Topic name? Programming Procedures

Description: (what student can learn after Day 7?) After day 7 you will be able to understand Type of procedures How to write procedures

Day-8: Topic name? Database Testing

Description: (what student can learn after Day 8?) After day 8 you will be able to understand Type of Testing Page testing Database testing Procedure testing Reports testing

Day-9: Topic name? Data Entry

Description: (what student can learn after Day 9?) After day 9 you will be able to understand Documents for data entry Type of entry Data Loading Data testing

Day-10: Topic name? Vendor Data

Description: (what student can learn after Day 10?) After day 10 you will be able to understand Documents for Vendor data entry Type of Vendor data Understand the need and significance of Laboratory data generated in clinical trial Understand the types of Laboratory used in Clinical Trial Identify the required Data from Lab

Day-11: Topic name? Coding

Description: (what student can learn after Day 11?) After day 11 you will be able to understand Understand the need for coding Understand the process for coding of clinical research data Identify the terms that are required to be coded Relate the coding terms and information data that is captured in an effective and consistent manner to facilitate meaningful interpretation

Day-12: Topic name? Discrepancy Management

Description: (what student can learn after Day 12?) After day 12 you will be able to understand The process of Discrepancy Management

Day-13: Topic name? Query Writing

Description: (what student can learn after Day 13?) After day 13 you will be able to understand Session on query writing

Day-14: Topic name? Safety Data Management

Description: (what student can learn after Day 14?) After day 14 you will be able to understand Understand the safety data involved in clinical trials Importance of Safety data The processes involved in management of Safety Data

Day-15: Topic name? Reporting in Data Management

Description: (what student can learn after Day 15?) After day 15 you will be able to understand Definitions Raw Data SDTM Derived Datasets Quality Check (QC) / Peer Review Generation of Reports Creation of reports E-Publishing

Day-16: Topic name? Pre DB Lock Activities

Description: (what student can learn after Day 16?) After day 16 you will be able to understand Introduction to Database Lock Consistency Checks for Critical modules

Day-17: Topic name? QA and QC in DM

Description: (what student can learn after Day 17?) After day 17 you will be able to understand Understand the requirement to be audit/ inspection ready, procedures to be followed and role and responsibilities of team members To introduce the quality management process and key quality management activities To understand the basic concept of Quality Management

Day-18: Topic name? QA and QC in DM

Description: (what student can learn after Day 18?) After day 18 you will be able to understand Understand the definition of Audit and Inspection Understand difference between Audit and Inspection Understand the purpose of an Audit

Day-19: Topic name? QA and QC in DM

Description: (what student can learn after Day 19?) After day 19 you will be able to understand Locking Definition Unlocking definition Steps to Unlocking

Day-20: Topic name? QA and QC in DM

Description: (what student can learn after Day 20?) After day 20 you will be able to understand DEFINITIONS:  What are SOPs? Objectives Necessity Non-Compliance with SOPs Additional Benefits Note: repeat this until last day of your Course

Project Classes

Day-1: project content? Description: (what student can learn after Day 1?) Day-2: project content? Description: (what student can learn after Day 2?) Day-3: project content? Description: (what student can learn after Day 3?) Day-4: project content? Description: (what student can learn after Day 4?) Note: repeat this until last day of yourProject. How you help to the Student to build the resume? How you will prepare them for the Interview?

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