Preparing Clinical Trial Data

Clinical trial data come to the statistical programmer in two basic forms numeric variables and character string (text) variables. With this in mind, there are two considerations for all numeric and text variables. All data should be cleaned if they are needed for analyses, and any data entered asfree-text variables should be coded or categorized if they are needed for analyses. 

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In preparing clinical trial data, the following instructions as well as the... 

This chapter describes the key clinical data preparation issues and the different classes of clinical data found in clinical trials. Each class of data brings with it a different set of challenges and special handling issues. Sample case report form (CRF) pages are provided with each type of data to aid you in visualizing what the data look like. The key data preparation issues presented are concepts that apply universally across the various classes of clinical trial data. 

Chapter 2 Preparing and Classifying Clinical Trial Data 21... 

Upon completion of the Clinical Trial, and any prior publication of multi-centre data, or when the Clinical Trial data are adequate (in Sponsor s reasonable judgement), the NHS Trust may prepare the data deriving from the Clinical Trial for publication. Such data will be submitted to the Sponsor for review and comment prior to publication. In order to ensure that the Sponsor will be able to make comments and suggestions where pertinent, material for public dissemination will be submitted to the Sponsor for review at least sixty (60) days (or the time limit specified in the Protocol if longer) prior to submission for publication, public dissemination, or review by a publication committee. 

CSOs assisting clients with clinical trial design need to be an extension of the client s project team and have access to all the data to assist in developing a realistic clinical trial package to determine the safety and efficacy of a drug candidate. In addition to assisting clients with clinical development plans and preparing clinical trial protocols, many of these CSOs also offer... 

Systems audits in this late phase in clinical trials aim at assessing related procedures to ensure that capable procedures exist for managing and cleaning clinical trial data, for conducting statistical analyses and for preparing the final study report which represents properly the data collected and reported in the clinical trial. Such systems audits are performed across functional boundaries. Such systems audit can be combined with a database audit and/or an audit of the final study report. 

Kessler asserted, FDA would be forced to approve new drugs using summaries of safety data prepared by drug companies. Untrue. The bill would have allowed FDA experts to depend on condensed, tabulated, or summarized data (when considered adequate) rather than reviewing the voluminous raw data from clinical trials, often running to hundreds of thousands of pages. In all cases, agency reviewers would have had access to additional materials as well, and could have obtained them by a simple request from an FDA supervisory official. 

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