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10478 Development of a Clinical Study Report - 3-Part Online Training Series
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Title:
Development of a Clinical Study Report - 3-Part Online Training Series
Date(s) And Time(s):
Sep 16 2010 10:00AM - Sep 30 2010 12:00PM
Interest Area(s):
Professional Education, Training & Development,Clinical Safety/Pharmacovigilance,Clinical Research,Medical Communications,Medical Writing,Project Management,Regulatory Affairs
Overview:
Introductory training course for individuals who are new to writing or reviewing integrated clinical study reports.
WHAT YOU WILL LEARN
• Structure and format of an integrated clinical study report in accordance with ICH guidelines
• Investigational plans using statistical methodology
• Study population and protocol deviations
• Placement and presentation of study information and data in various report sections including tables, appendices, and supporting documentation
• Safety and efficacy results
• Pharmacokinetic and/or pharmacodynamic endpoints
• Acceptability of abbreviated study reports
Part 1 – Thursday, September 16, 2010
12:00 pm-2:00 pm EDT
• Introduction, purpose, and general requirements of a clinical study report
• Clinical study report organization and hints on authorship
• Other types of study reports
- Abbreviated reports
- Synoptic reports
• Title page, ethics, and study administrative structure
• Introduction and study objectives
Part 2 – Thursday, September 23, 2010
12:00 pm-2:00 pm EDT
• Investigational plan through statistical methodology
• Effective data presentations
• Study population and protocol deviations
• Efficacy results
Part 3 – Thursday, September 30, 2010
12:00 pm-2:00 pm EDT
• Safety results
-Adverse events
-Clinical laboratory test findings
-Other safety variables
• Discussion, conclusions, and synopsis
• Review process
Learning Objectives:
At the conclusion of this online training series, participants should be able to:
• Recognize key regulatory requirements for integrated and abbreviated clinical study reports
• Describe the structure and format of a clinical study report and its relationship to the clinical study protocol
• Discuss various approaches to solving problems related to preparation, protocols, patient disposition, compliance, and changes to statistical methods
• Create a comprehensive and easily reviewable clinical study report
Target Audience:
• Clinical research and development professionals
• Medical writers
• Regulatory affairs personnel
• Biostatisticians
• Clinical operations professionals
Event Code:
10478
Contact Information:
For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Colleen.Buckley@diahome.org
If you have not received confirmation within 5 business days, please contact:
DIA
Tel. +1-215-442-6100
Fax +1-215-442-6199
Email confirmationservices@diahome.org
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Webinar
| Member Standard | $695.00 | | NonMember Standard | $750.00 | | Charitable Nonprofit/Academia Member | $350.00 | | Charitable Nonprofit/Academia Nonmember | $400.00 | | Member Government | $350.00 | | NonMember Government | $400.00 | | Group Site | $1750.00 |
Group Discounts:
GROUP SITE:
Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.
*Receive a 15% discount on the entire purchase when you register for more than one group site. Valid only for online purchases of group sites for this three-part webinar series.
This online training offering is sold as one complete series and cannot be purchased in parts.
ONLINE TRAINING SERIES: DIA accepts no liability for problems that may be encountered as a result of high traffic on the web. DIA will provide the Licensee with specific information for accessing the online training series. This information must be treated as proprietary and not given to anyone else.
CANCELLATIONS: No refunds will be provided in the event of a participant's cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Registered attendees will receive a confirmation letter with access instructions one week prior to Part 1 of this Online Training Series.
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Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; (703) 506-3275.
Drug Information Association is authorized by IACET to offer .6 CEUs for this program.
Continuing education credits are available to learners who participate in each session of the live online course. Continuing education credits are not available for the archived sessions of the online course.
| Development of a Clinical Study Report - 3-Part On | IACET
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Disclosure Policy:
It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must participate in each offering of the live on-line course and complete the on-line credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request.
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Minimum System Requirements:
To test your system compatibility, click on the link below.
https://diahome.webex.com/ec0605l/eventcenter/support/eventManager.do?siteurl=diahome
Operating Systems
Windows
2000, XP, 2003, 32-bit Vista, 64-bit Vista (not including Remote Access and Productivity Tools), 32-bit Windows 7, 64-bit Windows 7 (not including Remote Access and Productivity Tools).
Mac OS X
10.4, 10.5, 10.6
Linux
Ubuntu 9.04, Red Hat 5, Open SuSE 11.1, Fedora 11
Minimum System Requirements
Windows
Processor – Intel or AMD
JavaScript – JavaScript and cookies enables
Other – Active X enabled (unblocked for IE is recommended)
MAC OS X
Processor – PowerPC or Intel
JavaScript – JavaScript and cookies enabled
Other – Apple Java 5 or above
Linux
Processor – Intel or AMD
JavaScript – JavaScript and cookies enabled
Other – Sun Java 5 or above, libstdc++ 6.0, GNOME/KDE windowing system
Browsers (Recommended browsers are shown in bold)
Windows
Internet Explorer 6, 7, 8
Firefox 2/3/3.5
Chrome 3
Mac OS X
Firefox 2/3/3.5
Safari 4-Mar
Linux
Mozilla 1.7
Firefox 2/3/3.5
Internet Connection Speed
56k or faster
Display
800x600 pixel resolution or greater (1024x768 pixels recommended)
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Patricia A. Matone, PhD
President
Scientific Information Services LLC, United States
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