Managing a Blinded Study for the CDM

October 18, 2012: 11.00am EST, 17.00 CET, 21.30 IST

1 part webinar
60-minute presentation followed by 30-minute Q&A   

Overview
Blinded clinical trials are used to reduce bias on the part of the subjects, investigators or data analysts.  This webinar will examine the types of blinded clinical trials, management of these trials and procedures for unblinding these trials. Maintaining the blind for interim and final analyses is crucial and should be detailed in a blinding plan. The webinar will discuss when the project team members should be blinded and the responsibilities of the clinical data manager in maintaining the blind including the blinding plan. Randomization of subjects to the treatment arms is an essential component of blinded studies and will be considered in this webinar also. Finally, the procedures for both unplanned and planned unblinding will be examined.

What You’ll Learn
Attendees will be able to:

1. Describe the different types of blinded clinical trials.
2. Describe the responsibilities if the clinical data manager in blinded clinical trials.
3. Explain the role of the clinical data manager when other project team members are blinded.
4. Explain the importance of randomization in blinded clinical trials.
5. Describe the procedures for unplanned and planned unblinding.

Participation Benefits
Participants will understand the basic concepts, management, procedures and randomization of blinded clinical trials.

Who Should Attend
Beginners to intermediate, CRAs and biostatisticians.

Presenter
Susanne Prokscha has been involved in clinical data management (CDM) processes and technologies since the mid-1980’s.  She has worked both as a consultant and directly for companies large and small, gaining experience with a wide range of studies and a variety of clinical data management systems.  Her interest in advancing the field of CDM and helping emerging CDM groups led her to write: Practical Guide to Clinical Data Management, the third edition of which was published in October 2011. Susanne recently left Genentech to return to consulting where she specializes in helping smaller CDM organizations implement systems and develop processes.

Course Tuition

Individual: $300 members/$350 non-members

Group: $800 members/$950 non-members

Earn CEUs      
Participants are eligible to receive CEUs upon attendance and succesful completion of a web-based assesment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.