Successful
and timely clinical trial start-up is for key sponsors, CROs and investigative
sites. Too often, clinical trial start-up is challenged by delays in
investigator selection, Institutional Review Board (IRB)/Ethics Committee (EC)
budget approvals, or the discovery that once a site is initiated, the investigator/site
indicates the protocol is not feasible due to lack of subjects. This online
10-Hour Clinical Trial Start-Up Series will address how to overcome challenges
encountered in clinical trial start-up from understanding protocol requirements
and risks, exploring methods to improve the investigator/site understanding of
eligibility criteria, use of a Work Breakdown Structure (WBS) to help drive
timely IRB/EC and Clinical Trial Agreement (CTA)/budget approvals, and tools
and techniques for more engaging/ interactive site qualification and initiation
visits. Case studies, handouts, and tools will be provided for immediate
implementation to address your start-up needs.
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 comprehensive course materials. 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.
- Identify protocol requirements and risks
- Create tools and templates for
clinical trial start-up planning
- Examine best practices to improve
Investigator/site selection
- Create engaging interactions with
Investigator/site personnel during site interactions
- Identify situations where a Work
Breakdown Structure (WBS) would have a positive impact on clinical trial
start-up
- Module 1: The Clinical Protocol: Evaluation of
Requirements and Risks
- Module 2: Development of the
Investigator/Site Feasibility Questionnaire: Asking the Right Questions
for Your Protocol
- Module 3: Investigator/Site
Selection Visit: Matching Protocol Needs to Your Investigator/Site
- Module 4: Tools to Support Clinical
Teams for Timely Start-Up: Trackers, Questionnaires, and Communication
Practices that Yield Results
- Module 5: The Site Initiation
Visit: Engaging and Interactive Gets Results
- Clinical Project Managers/Leaders
- Clinical Trial Managers
- Clinical Research Associates
- Clinical Trial Assistants
- Other Team Members from
sponsors/CROs working in clinical trial start-up
- Clinical research Team Members from
Investigative Sites seeking to improve their start-up practices
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!”
Marla
Hoelle, BSN, RN, CCRA, ACRP-PM, PMP
Click here for complete trainer
biographies
2 hours/week for 5 weeks.
$1,595 by Early Bird Deadline
$1,795 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 10 hours (1.0 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#: 0778-0000-20-094-L04-P. Released: 8/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.