ClinPlus® Data Management

 

 

Full System

2 Days

 

Day 1 delves into the System and Study Administration modules. You will learn to set up the system options that will fit your company's business model including role and site-based security, the ability to create and maintain a library of standard databases and screen designs, and to model and quickly adapt complete studies to additional protocols. You will learn to build simple to complex data entry systems, range checks for individual variables, intricate cursor movement, and pop-up selection lists.

 

On the 2nd day, you will track in pages, perform 1st and 2nd key data entry, resolve discrepancies, update verified data, create a simple edit check program, run the program to produce queries, resolve queries that were produced manually or through the program, create and run your own user reports and run system reports, and learn how to convert the system to EDC using role-based menus.

 

 

 

 

Data Entry

½ Day

 

This interactive course allows data entry staff to learn how to enter data while receiving indepth knowledge of the ClinPlus data entry system. You will track in pages, perform 1st and 2nd key data entry, on-the-spot discrepancy correction, update verified data, employ the question and prompt libraries, and write manual queries from the data entry screen.

 

 

 

 

Advanced COVER Programs

½ Day

 

Basic knowledge of SAS is required. You will learn how to write simple edit checks using one data set to more complex edit checks using two or more data sets. Learn how to run the edit checks within the ClinPlus system as well as outside the system.

 

 

 

 

Advanced User Report Creation

½ Day

 

Basic knowledge of SAS is required. You will learn how to write simple to complex user reports including pre- and post- processing and multiple study reports.

 

 

 

 

Data Review Only

 

 

You will run edit check programs and learn how to manage the resulting queries. You will gain in depth knowledge of query statuses, managing and resolving queries, writing manual queries including employing the question and prompt libraries, running listing and reports, updating verified data, and creating query templates.

 

 

 

 

Study Design

½ Day

 

You will learn to build simple to complex data entry systems, range checks for individual variables, intricate cursor movement, and pop-up selection lists. You will learn the various options in building screens to expedite and improve the accuracy of data entry. You will explore the Format Builder and gain a better understanding of using formats and informats. You will develop questions and prompts that can be used for manual queries and edit check programs that will standardize your queries and save you time in retyping questions. You will explore screen design options including macro and SCL code usage.

 

 

 

 

System Administration – IT Focus

2 Hours

 

You will learn to initiate SAS Share and set security including login and password complexity rules. You will establish network rights for data and query documents. You will explore index and view management features. You will create user and group assignments and assign tasks and permissions at all levels. You will learn the steps to troubleshoot in the system.

 

 

 

 

System Administration – DM Focus

½ Day

 

You will create user and group accounts and assign tasks and permissions at all levels. You will Initialize source and study parameters, import and export data, modify report templates, maintain variable and investigator libraries, model a study, create query templates, and gain an understanding of network rights and data access.

 

 

 

ClinPlus® Coding 3

 

 

Full System

1 Day

 

You will gain an understanding of the flexibility of the auto and manual coding processes by learning the system set-up and recommended mappings and becoming skilled in using the phrase substitution lists, thesaurus, and perpetuation features. You will produce customized coding listings on All Records, Un-coded Records, or Unselected Classifications.

 

 

 

ClinPlus® Report

 

 

Basic

2 Days

 

Discover why ClinPlus Report has been adopted as the standard by several of the top 10 pharmaceutical companies. You will produce complex FDA-ready statistical tables and listings of NDA quality, using over 70 different statistics across numerous SAS®/STAT procedures while you choose precision, group and class variables, sub-setting, subtotals, and more. You will learn to control inclusion/exclusion of columns not present in the data, join categorical and continuous statistics within a single cell, decimal point alignment, text wrapping on word boundaries, multiple justifications within a single title/footnote line, flexible page numbering (n of tot , n (Last), etc.), conditional footnotes, extensive page-handling intelligence, etc.