A logical process for building a study has been created in Clinical Studio. This document will explain how to use that process to build a study.
Study Build Progress Window
Creating a study is easy when the step by step process outlined in this document is followed. The system has this process built in as the Study Build Progress Window. That window can be accessed if you have the rights to theStudy Configuration application for the currently selected study.
Clicking the Progress link, which is always available for the currently selected study, will bring up the Study Build Progress Window as shown in the following figure.
This window contains all the tasks necessary for building a study and moving the study live. By moving a study live you are effectively deploying that study to all the sites which have been registered with the study. The task list is in a logical order. However, the order can be deviated from in certain cases. Not all of the tasks are mandatory. For example, if your study does not use randomization, then it is not necessary for you to “Setup Randomization for Study.”
The Study Build Progress window is designed to allow you, the Study Designer, to be able to quickly navigate to the required tasks, in a logical order. In some cases, prior to navigating to a particular task, that task will have already been completed. That is because of the default settings that are brought over each time you create a new study. For more about Default Study, see the Create Study help document.
There are several columns in the Study Build Progress window:
This column gives an abbreviated description as to what the task is. For a more detailed description, hover your mouse over the Page column and a hover help window will appear. For a complete description, access the corresponding help document.
This column provides a link to the page where you will complete the study build task. Remember, to return to the Study Build Progress window, click theProgress link, which is always displayed in the page header.
In addition to providing a link to the task page, if you hover your mouse over this column, you can get a more detailed description of the task in a Tool Tip popup window.
The status column allows you to check a box to denote that you have completed the task. Each column checked increments the Percent Completeindicator, located next to the “Done” button in the Study Progress window. The system automatically saves the state of each checkbox control and restores that state each time the Study Build Progress window is displayed.
This column provides a link to the help page corresponding to each task. The help page is opened in another browser tab for easy reference back and forth. Each help page gives a set of instructions for completing the corresponding task. When you are in the task page (by clicking corresponding Page link), you can get even more help by clicking the Help link that is always available in the page header. This will bring up an index of help files related to the current application.
Description of Tasks Required to Build a Study
There are 18 main tasks to building a study. Many of these tasks will be nearly complete or entirely complete because of the default study which was copied. This should just familiarize you with the task. For a complete understanding of the task see the corresponding help documents.
The following is a description of each task:
1. Setup Study Roles and Rights
Because of the complexity of clinical studies, many different users must participate. Those users all have different roles within the study. Depending on their roles they are assigned access rights. Each type of role must be setup prior to assigning a given user their role. Most of this should be completed when creating the study and only a little touch-up work should be required here.
2. Define Functionality
Depending on the type of study you are conducting, you need to define the functionality that is required by the study. Does the study require randomization, interval date entry, etc. This page allows you to define this using a series of check boxes. Each checkbox is thoroughly explained in the Study Configuration – Functionality help document.
3. Define Study Workflow
The workflow of the study determines how records are entered and reviewed within the system. The first step is for the data coordinator to enter a record and cleanse that record. After the record is cleansed and has no open queries, the record will probably need to go through a series of review levels. Here is where those review levels will be defined.
4. Define Query Management
There are two types of queries in Clinical Studio; automatic and manual. Automatic queries are created by the system when an edit check fails. Manual queries are left by users that have the appropriate rights. Queries are how data is reviewed and cleansed. Queries create a line of communication between the various review level roles and the site users. However, queries can be deployed to any user role. Again, this entire task may be completed for you when the default study is created.
5. Define Study Metrics
Study enrollment projections are defined on this page and compared against actual results in the Dashboard report.
6. Set Up Audit System
Depending on the type of study, Clinical Studio has various levels of auditing. Here is where you will define the types of audits necessary for your study.
7. Protocol Versioning and IRB
Clinical Studio has a powerful protocol versioning system built in that allows you to tie sites to various protocol versions. Then based on which version a given site has approval to access through IRB, the appropriate forms and visit pages will be displayed.
8. Build/Import Subject CRFs
Building your CRFs is very important. The CRFs determine how and what content will be provided by the site users. When you create CRFs, Clinical Studio creates the backend data model. Those forms, however, once created can be reused in any other study. This is where you will manage the creation and deployment of CRFs.
9. Set Up Scheduled Visit Table
The Scheduled Visit Table allows your site users to enter data at the appropriate time intervals into the appropriate forms in accordance with the study protocol. Here is where you define the scheduled visits and the acceptable visit windows for the study.
10. Set Up Variable Visit Table
The Variable Visit tables allow you to capture non-scheduled data. Here you define the variable tables (if any) and the forms that must be completed for an unscheduled visit or event.
11. Add Sites to Study
Here is where you will add which sites are to participate in your study. Sites are entered using the Site Manager.
12. Add Users to Study
Here you will add users to the study. The users will belong to a site that belongs to the study. You will assign the user the appropriate role here as well.
13. Set Up Randomization for Study
Clinical Studio has a very powerful randomization system. You can randomize by saving any form at any visit interval. You can stratify by as many variables as you like, including site. Randomization tables are uploaded into Clinical Studio, then as CRFs are saved, randomizations are triggered. Based on randomization allocations you can hide forms, intervals and fields using conditional actions. Here is where all of that is defined and set up.
14. Set Up Regulatory Site Documents
Most studies require that sites complete a series of regulatory documents for the Website Host. Here is where all of that is captured electronically and can even be tied to Subject Enrollment.
15. Add Test Data to Study
Once your study is set up and CRFs have been completed, you should add some test data to the study. Clinical Studio has several facilities for doing just that. This gives you a feel for your CRFs and how usable they are.
16. Auto-Validate CRFs
Prior to moving a study live, all CRFs must be validated. Clinical Studio has developed a very powerful feature that allows you to create large blocks of test data (automatically) for each CRF. That test data runs different combinations of data through the CRF and fires edit checks and other conditional actions. At the end of the process a comprehensive log of the results of the CRF data submission is created. That log can be searched and archived. When a CRF has been validated, it can be tagged as such.
17. Move Study Live
From a single area in Clinical Studio you can set the status of the study. Depending on the study status, you can prevent sites from entering new data or editing existing data. When you are ready, you can move the study live which allows your provider sites to begin adding data to the study.
18. Export Study Data to SAS, SPSS, ODM, Excel
Before, during and after the study, at any time, you can take the study data and create readable datasets for all the popular statistical analysis packages and reporting engines. This can be done with a single mouse click.