The Basics of Clinical Data Management From Start to End
Dec 3 2014 8:30AM - Dec 3 2014 5:00PM | DIA Global Center
21 Dupont Circle NW, Suite 300
Washington, DC 20036
This one day face-to-face course will introduce participants to the basic principles of clinical data management. Relevant information and instruction will be covered on data management to include, data capture instrument design, data editing, data tracking, metrics, and much more. This interactive course will allow participants the opportunity to run through a series of hands on exercises.
This course offers a webinar titled, The Role of the Clinical Data Manager which helps you prepare for the course and become familiar with the role of the clinical data manager in the context of the drug development process. The webinar takes place on October 8, 2014. Those who preregister for this meeting will receive a complimentary registration for the webinar.
Course Level: Beginner
What You Will Learn
- How to develop a case report form
- How to define a database structure and understand the various forms associated with database structures
- Challenges and solutions related to the data entry process
- How to check data to ensure proper quality
- How to check and track study status and provide metrics to other functions
Who Should Attend
Data management professionals with less than one year of pharmaceutical or related industry experience, including:
- Study managers
- Monitors / CRAs
- EDC developers
- Project managers
- Medical writers
- Regulatory affairs professionals
- Clinical safety and pharmacovigilance professionals
At the conclusion of this course, participants should be able to:
- Develop a case report form (CRF) based on a protocol and standards
- Describe the setup of a database structure for the data capture and storage activities
- Develop rules for data entry based on paper CRFs
- Recognize how to create edit checks for data checking
- Discuss and recognize how to keep an oversight on studies
Group Discounts Available! Register 3 and Get the 4th FREE!
Hotel & Travel
Training Course Location
DIA Global Center
21 Dupont Circle NW, Suite 300
Washington, DC 20036
Toll Free 1.888.257.6457
Monday-Friday 8:30AM-8:00PM ET
Agenda Details and Event Logistics
Colleen Buckley, Event Planner
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .7 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Research Certificate Program: 4 Elective Unit each
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units each
• Project Management Certificate Program: 4 Elective Units each
• Regulatory Affairs Certificate Program: 4 Elective Units each
For more information go to www.diahome.org/certificateprograms
|The Basics of Clinical Data Management From Start
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must attend the course, sign-in at the DIA registration desk, and complete the on-line credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on two weeks after the last day of the course.
To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE
- Charitable Nonprofit/Academia Member
- Member Government
- Member Standard
- Member Standard (As of 11/13/2014)
- Charitable Nonprofit/Academia Nonmember
- NonMember Government
- NonMember Standard
Printable Registration Form
Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.
To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
Cancellations: Cancellations must be received two weeks prior to the first day of the course. A $200 administrative charge will be deducted from the original registration fee. Cancellations must be in writing and received in the DIA office according to the timeline above. There will be no refund if cancellation is received within two weeks from the first day of the course. Registrants are responsible for cancelling their own hotel and travel reservations. Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.
Transfers: You may transfer your registration to a colleague at any time but membership is not transferable. Please notify the DIA North American office of such transfers in writing as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.