Maintaining Standards Affiliations

A goal of Global Library management is to maximize conformity among data collecting components common to all clinical studies, or to groups of similar clinical studies, so that you can make direct comparisons. Standards affiliations standardize data collection in new clinical studies by helping classify, locate, and track the use of the Global Library objects.

For example, if a standard Question Group is affiliated with the affiliations type SYSTEM, you can suggest that all studies in the Oracle Clinical system reference that Question Group. Such a reference, constituting a system-wide standard, might be a requirement of uniform collection of data about safety, which would require that all studies use a standard safety Question Group called SAFETY_QUES. The Global Librarian sets these requirements.

Standards are defined by affiliations types, which are maintained through the form Maintain Standards Affiliations (from the Glib menu, select Standards Affiliations).

Affiliations is the means by which Oracle Clinical reaches these ends.

For more information, see:

• Using Affiliations
  
• Maintaining Affiliations
  

Using Affiliations

This section describes the workflow for affiliations in the Global Library and the procedure for locating library Question Groups, DCIs, DCMs, and both Derivation and Validation Procedure definitions with affiliations.

These are the tasks that you can accomplish by using standards affiliations:

1. You can locate library objects such as Active Questions, Question Groups and DCMs, Global Library DCIs, DCMs, and Validation and Derivation Procedures. For this task, first choose the affiliations types pertinent to the study. Then use these to locate the library objects for the new clinical study. Related reports help you identify library objects left out of the new clinical study and to monitor other uses of affiliations.
2. Affiliating library objects with affiliation types, so that the objects can be located later. This activity is performed by the Global Librarian.
3. The Global Librarian can create new affiliations types.

For more information, see:

• Locating Library Objects
  
• Mapping Library Objects to Affiliation Types
  

Locating Library Objects

You can use the following method to locate library DCMs, DCIs, and Validation and Derivation Procedures from the corresponding study definition forms.

To locate Question Groups with affiliations, select Locate QG by SA from the Special menu to open the Query Library Objects by SAS dialog box.

1. Move the insertion point to the Standards Affil. Type field. Enter the affiliation type you want, or select a value from the list of values. If you select one of the listed values, the Standards Affiliation Name field is filled automatically.
2. Select the Required? field if you want only Question Groups that are REQUIRED; or, to locate all affiliated Question Groups, leave that field blank.
3. Select the OK button or Save to initiate the query. The Question Groups form reappears, displaying only those Question Groups that have been associated with the affiliations you entered.

Mapping Library Objects to Affiliation Types

You can map library Question Groups, DCMs, DCIs, and procedures to affiliation types.

For example, if you want to associate a Question Group with the indication of angina and a particular compound, enter the same set value for the two records. If the affiliation is for the indication of angina or a particular compound, use different set numbers to indicate that they are independent affiliations. Select the Required? field if this is a required affiliation, or leave it blank if the affiliation is simply recommended.

To map library objects to affiliation types, follow these instructions:

1. Navigate to one of these Global Library maintenance windows, or their Provisional equivalents:

   • From the Glib menu, select Question Groups, then choose Question Groups.

   • From the Glib menu, select DCIs DCMs Procedures, then choose DCIs.

   • From the Glib menu, select DCIs DCMs Procedures, then choose DCMs.

   • From the Glib menu, select DCIs DCMs Procedures, then choose Validation Procedures.

   • From the Glib menu, select DCIs DCMs Procedures, then choose Derivation Procedures.

2. Locate or create the object you want to map to an affiliation.
3. Select the Standards Affiliations button. The Standards Affiliations Set dialog box opens.
4. Create a new affiliation by entering values in the Standards Affiliations Type and Standards Affiliations Name fields. Use the Set field to group two SA records in the same affiliation.
5. Click Save to save the affiliation, then click Back to return to the Question Groups window.

Maintaining Affiliations

Maintaining affiliations consists of determining whether affiliations are active and whether Question Groups affiliated with specific standards are required or recommended. New standards affiliations areas are created in the Maintain Standards Affiliations form; from the Glib menu, select Standards Affiliations. The Maintain Standards Affiliations form appears, with the cursor in the Standards Affiliations Type field.

1. Enter a type or select a value from the list of values. (You cannot create a new standards affiliations type from this form; the types are part of a reference codelist and populated at the installation level.)
2. The cursor goes to the Affiliation Name field, and existing values are displayed. Enter a new affiliations name by moving the cursor to the first blank field and typing in the name.
3. Click Save to save the new entries. The entries are immediately available for association.