To set up a study, Central Designer, InForm, and DMW users can work on their product tasks at the same time.  

InForm

4 Tasks

1

Install and configure the skeletal study

(Installer) Before you can deploy a study, you must set up the basic framework to hold your study design and data. This framework is called a skeletal study.

2

Install the Central Designer certificate

(Installer) You must install a certificate on the InForm application server to verify that every deployment package you receive from the Central Designer server comes from a trusted source.

3

Install the Central Designer rule engine

(Installer) Run the InstallCentralDesignerFiles command to install and register the Central Designer rules engine, as well as other files the InForm application uses for automated deployments.

4

(Administrator) A deployment user is any sponsor user with the Study Deployment right. You create deployment users in the InForm user interface or with the MedML Installer utility.

DMW

6 Tasks

1

Create the study

(Study Builder) Specify a name and other attributes. Apply a study template (optional) to reuse clinical data models, transformations, and validation checks. You can delete any you don’t need.

2

(Administrator) Select tables and views to be available in all studies by default. An administrator performs this task one time, and the tables are selected for all studies.

3

Create the users required for InForm integration

(Study Administrator) Create required Oracle and InForm user accounts to send metadata between InForm and DMW.

4

Set up the Study File Watcher

(Administrator) Specify the file system location where the system will watch for data files to load into DMW for the study.

5

Create or reuse input clinical data models

for labs

(Study Builder) Create a set of tables to contain data from each lab to be used in the study.

6

Create or reuse target clinical data models

for transformed data

(Study Builder) Create a set of tables to contain data from each lab to be used in the study.

Central Designer

5 Tasks

1

Create special InForm visits and forms

(Study Designer) Create the visits and forms that are required in InForm, and meet the special design requirements to make sure that the form data is handled correctly in an InForm Study.

2

Configure the query groups for the study

(Study Administrator) Create the query groups that you can add users to in InForm. Those users are identified as the users who can act on queries created by other members of the group in InForm.

3

Select the study’s sponsor

(Study Administrator) Select from a list of possible study sponsors to associate your study with a specific sponsor, or add a new sponsor to the study.

4

Configure the system settings for the study

(Study Administrator) Select the InForm release you are deploying your study to, and configure the system configuration settings that you want to use for the study.

5

Validate your study

(Study Validator)