Course Description

The online 30-Hour Clinical Data Management On-Boarding Program is designed to provide a comprehensive and foundational study of the best practices which have been identified in the discipline of Clinical Data Management (CDM). From protocol review and identifying study design to the required data elements and the final steps at the milestone of database lock, we will identify and discuss crucial CDM processes. Information presented will give new Clinical Data Management personnel a robust view of all CDM processes. This on-boarding program will also assist individuals to refresh their knowledge if they are preparing to sit for the certification examination.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Define best practices as they apply to CDM processes
• Describe CDM processes from study start-up to database lock
• Apply best practice rationale when assessing data collection requirements/instruments
• Evaluate the benefits of standardization in establishing CDM processes
• Discuss current technology/methods of data collection and associated documentation

Course Outline

• Module 1: FDA Guidances, Protocol Review, and Data Management Plan Creation and Content
• Module 2: Case Report Form Design (CRF/eCRF), and Edit Check Creation
• Module 3: Electronic Data Capture: Selecting an Application, Implementing the System, and Study Conduct
• Module 4: Database Validation, Data Entry Processes (EDC/Paper-based Studies), and Data Standards (CDISC/CDASH)
• Module 5: Data Quality and Metrics
• Module 6: External Data: Data Transfer Agreements, Patient Reported Outcomes, and Laboratory Data
• Module 7: Safety Data Management and Reporting, Serious Adverse Event Reconciliation, and Medical Coding Dictionaries
• Module 8: Database Lock, Clinical Data Archiving, and Data Storage
• Module 9: Project Management for the Clinical Data Manager including Vendor Selection
• Module 10: CDM Presentations at Investigator Meetings and Risk-Based Monitoring, Risk Assessment and Quality by Design

Who Should Attend

• New or aspiring Clinical Data Managers
• Clinical Data Managers
• Data Coordinators
• Project Managers
• College Students and New Graduates in a Scientific Field
• This course is also ideal for “on-boarding” of individual new hires or entire teams (individual registrations required)

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

Denise G. Redkar-Brown, MT

Click here for complete trainer biographies

Course Length and Time

10 weeks for 3 hours each week.

Registration Fees

$1,795 by Early Bird Deadline

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-038-L99-P. Released: 8/24.  

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.