ACDM - Level One Certificate in CDM - Part 1 of 8

Course overview
This course consists of 8 webinars and an exam. It provides a broad understanding of clinical data management fundamentals; set within the context of the drug development process. It introduces participants to the processes, concepts and terms used in clinical data management.

Who should attend?
This course is written for Data Managers with limited or no experience of data management. It would also benefit anyone working within drug development who wants to gain a knowledge and appreciation of the data management function within the drug development process.

Content
• Key Interactions
 - Who makes up a study team?
 -  With whom do CDMs need to liaise?
• Essential Documents
 -  Protocol
 -  CRF
 -  Data Management Plan
 -  TMF
• Quality Control and Quality Assurance
• Who are the regulators?
 -  MHRA
 -  FDA
 -  EMEA
 -  MHLW
 -  Ethics Committees
• What is ICH/GCP?
• (e)CRF Development
 -  Patient Diaries
 -  Quality of Life Questionnaires
• Database Design
 -  Annotated CRF
 -  Database Specifications
 -  Data Management Plan
• Data Acquisition and Tracking
• Data Review and ‘cleaning’
 -  Data verification and validation (edit checks, listings, manual review)
 -  Concept of Obvious Data Corrections (self Evident Data Corrections)
• Query Management
 -  Standard Query Text
 -  What Makes a Good Query? 
 -  What Makes a Good Response?
• Coding
 -  Medical Terms and Conditions
 -  Coding Dictionaries
• Safety Data
 - What is it?
 -  Definition and Classification of Adverse Events
 - Reconciliation of Adverse Events
• Third Party Data
 -  What is it?
 -  Central Laboratory Data
 -  ECG
 -  EEG
 -  Biomarkers
 -  PK Data
 -  Data Transfer Specifications
• Protocol Deviations
• Database Locks
 -  Clinical Data Review
 -  Interims
 -  Final
• Core checklist
• Determining Error Rate
• Avoiding Unlocks

By the end of this course you will:
• Have gained a basic understanding of clinical data management fundamentals: terms and concepts, key interactions & key documents
• Appreciate the breadth and variety of tasks required of data managers associated with trial set-up, conduct and close-out
• Know who the industry regulators and authorities are and the significance of ICH and GCP
• Have learnt the need for and rationale behind the requirement for quality in all aspects of the clinical trial processes

Webinar Dates:
This course will be held as eight 'webinars' from 12:00 - 13.30 on the following dates. Please note delegates must attend all eight webinars and the exam to complete the course.

Tuesday 14th September
Tuesday 26th October
Tuesday 16th November
Tuesday 14th December
(Four other dates to be confirmed)

Webinar participation is £835 plus VAT per delegate for non-members and £710 plus VAT per delegate for ACDM Members

Proceeding to book a place on this course you are agreeing to our terms and conditions.  Click here to view the terms and conditions.