ACDM - Level One Certificate in CDM (includes exam)

Course overview
This two day course 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 management professionals 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 reviews
 -  Interim
 -  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

Course Format
The course is highly interactive and includes a variety of trainer input, group activities and personal reflection. Participants will be encouraged to interact with each-other, contribute to class discussions and share their experiences.

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

The course will be held from Tuesday 23rd & Wednesday 24th June 2010 (2 days) from 09:30 - 16:30, The course will be held at the Moor Hall Conference Centre, Thames Valley.

Please contact the venue direct to book any accommodation requirements.