Clinical Data Management

OVERVIEW The aspects of Clinical Data Management that impact data quality. These will come from things like the study protocol, the computer systems used, the various sources of data, written standard operating procedures and other practices that involve the data.

WHY SHOULD YOU ATTEND There are a variety of problems (and opportunities) that can occur during the trial. If these are overlooked they can make the study worthless or double the cost of the study. These are things like; Systematic Errors that occur because a procedure is not being executed properly. Inspections are often conducted by the agency. The inspection might be done after the study is complete and therefore any problems can probably not be corrected without re-doing the entire study. Audits should be done by the Sponsor of the trial, the CRO, or the clinical site itself. Lost Data/Information can happen during the trial. It might occur when a change is made. Regulations are vital to the conduct of the trial. Those responsible for the study must be aware of ALL regulations that apply to the conduct of the study. Compliance is a very important aspect of conducting the clinical trial and any procedures related to the study. AREAS COVERED The roles and responsibilities of those involved in Clinical Data management will be discussed. These will include topics such as Quality and Compliance. The data sources and the practices used to generate and record the data are vital. This has to include things like Who collected the observation? Are they trained? What equipment was used? Was it calibrated? Did it have sufficient power? Are there edit checks performed? Then we will look at the resulting database(s). There may be an End Point database or other specialized databases. These are typically covered by the same needs and regulations as a standard clinical trial database. LEARNING OBJECTIVES Learn about the various aspects of Clinical Data Management that impact data quality including computer systems, sources of data, operating procedures, study protocol and other practices. WHO WILL BENEFIT Data Managers Clinical Research Associates Quality Assurance Statistical Programmers SPEAKER Richard Chamberlain’s experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.

Apart from these Mr Chamberlain has taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems; assisted in the development and validation of numerous computerized systems in all GxP environments; assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations. He is also familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs. For more detail please click on this below link: http://bit.ly/2G4AN4x