Take advantage of our $1507.50 price by registering early!* After Friday, May 28, 2021, costs are $1687.50.
This
course focuses on the responsibilities of the Clinical Trial Assistant or
Associate (CTA), a key administrative member of a project team at the sponsor
or CRO. It will start by providing the foundational knowledge of how drugs and
medical devices are developed and approved, and the importance of ICH GCP and
FDA regulations in the conduct of clinical trials. From there, the various
roles and responsibilities of the clinical research team will be introduced,
followed by a discussion of the importance of the CTA role in daily
administrative operations of clinical trials. Responsibilities the CTA provides
to the clinical trial team will be reviewed in depth, which include the
following: Study start-up, maintenance, and closure, essential documentation
tracking and management using the Trial Master File, distribution and
management of adequate studies supplies (e.g., investigational product,
laboratory kits, and other items used by the investigative site),
reconciliation of documentation, coordination of team meetings, management and
updating of study trackers, and the creation of documentation used in clinical
trials (e.g., regulatory binder, newsletters).
- Review FDA regulations and the ICH GCP E6
Guideline for Good Clinical Practice (GCP)
- Describe the role the Clinical Trial
Assistant and other team members in clinical research
- Describe the investigational product
development process: Drug and device
- List essential documentation
required in the conduct of clinical research
- Describe the Trial Master File
- Develop tracking tools used in
clinical research
- Define investigational product
management and accountability in clinical research
- Clinical Trial Associates
- Clinical Trial Assistants
- Clinical Coordinators at the sponsor
or CRO
The course will be led by one of the following
instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A., ACRP-PM., P.M.P.
Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.
Click here for complete trainer
biographies
Day One: 8:30 a.m. – 5:00 p.m.
- Module 1: ICH GCP and FDA Regulations
- Module 2: Roles and Responsibilities of the Clinical Research Team
- Module 3: Investigational Product Development: Drug and Device
Approval Process
- Module 4: Investigational Product: Accountability, Management, and
Issues Management
Day
Two: 8:30 a.m. – 5:00 p.m.
- Module 5: Trial Master File: Set up, Maintain, and Manage
- Module 6: Clinical Trial Start Up Process and Essential
Documentation
- Module 7: Clinical Trial Maintenance and Essential Documentation
- Module 8: Clinical Trial Close Out and Essential Documentation
- Define Clinical Research Team Responsibilities
- Trial Master File Set Up
Requirements
- Review of Essential Documentation
for Completion and Acceptance: Form
FDA 1572, Financial Disclosure Form, Curriculum Vitae, Medical Licensure,
IRB Correspondence
- Simulation Exercise: Clinical Trial
Start-Up, Maintenance, and Closure
Registration
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that will
be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
Click here for our seminar
cancellation policy
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 15 hours (1.5 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-19-020-L01-P.
Released: 3/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
