Take advantage of our $1615.50 price by registering early!* After Friday, February 5, 2021, costs are $1795.50.
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.
The resources required to
take this on-line course are already at your fingertips - an Internet
connection and a phone. After registering, you will receive an email
confirmation that provides you with the Web Seminar link and audio connection
information.
Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class
prepared to interact – you will be able to ask questions, provide feedback and
participate in discussions and group work. 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.
- 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
- 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 CDM Training
- 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!”
Denise
G. Redkar-Brown, MT
Click here for complete trainer
biographies
10 weeks for 3 hours each week.
$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.
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#:
0778-0000-19-004-L01-P. Released: 1/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
