Using DCI Book Assignment

Use DCI Book assignment in any study that uses multiple DCI Books, either sequentially for protocol amendments or in parallel for multi-arm studies. Assigning patients to DCI Books ensures that the correct forms are used for each patient.

Changing the book assignment, either manually or in a validation or derivation procedure, is one way to move a patient from a screening book to a treatment protocol, or from one treatment protocol to another. Likewise, protocol amendments can be introduced in a new DCI Book definition, and patients can be re-assigned to the new book as the protocol amendment is rolled out.

The OCL_STATE local codelist has two values, BOOK_CHANGE and BOOK_ASSIGN, that you can use for DCI Book assignment and re-assignment. The following table describes the codelist values for assigning DCI books:

Short Value	Valid Long Values	Description
BOOK_ASSIGN	Y (default) N	Specifies whether RDC automatically assigns a DCI book to the patient upon initial data entry.
BOOK_CHANGE	ALLOW (default) DISALLOW DISALLOW IF DATA	Determines whether the DCI book assignment for a patient can change.

Your options for assigning patients to DCI Books are:

• Manually Assigning Patients to DCI Books Using Oracle Clinical
  
• Automatically Assigning the DCI Book upon Initial Data Entry
  
• Allowing Patient Book Assignments to Change
  

Manually Assigning Patients to DCI Books Using Oracle Clinical

To use Oracle Clinical to manually assign patients to DCI Books:

1. Open Oracle Clinical.
2. Navigate to Design, Patient Positions, and then select Patients.
3. Select your study from the list of clinical studies.
4. Click Patient Positions to open the Patient Positions form.
5. Scroll to the right of the form.
6. Enter the DCI Booknames for one or more patients.

Automatically Assigning the DCI Book upon Initial Data Entry

As an alternative to pre-assigning DCI Books by manually updating the Patient Positions table, you can specify that RDC automatically assign each patient to a book upon initial data entry.

Automatic book assignment works as follows:

• You provide instructions, if necessary, to your RDC users as to what book to use for initial data entry.
  • If only one book is active in a study at a time, no instructions are necessary.
  • If you have multiple active books defined, instructions are needed. When first invoked, the RDC Casebooks page always displays the default casebook you specified at study definition time. RDC uses this casebook for entering data for unassigned patients. However, the user can select another casebook on the Casebooks page.
• When an RDC user enters and saves the first CRF for a patient, RDC automatically assigns the patient to the book in context; that is, RDC updates the Patient Positions table for that patient. Note that the assignment is ONLY made if the patient is currently unassigned.
• Once a patient is assigned to a casebook, RDC enforces use of the casebook for future data entry. The user can no longer change the casebook used simply by changing the casebook in context on the RDC Casebooks page.

To set up automatic book assignment at study definition time:

1. Open Oracle Clinical.
2. Define the DCI Book that RDC uses by default for entering data for patients.
   1. Navigate to Definition, DCIs, and then select DCI Books.
   2. Select the Default check box for the DCI Book to use as the default.
   3. Save your changes.
3. Turn on automatic book assignment.
   1. Navigate to Admin, Reference Codelists, and then select Local Codelists.
   2. Query for the OCL_STATE local reference codelist. (Enter OCL_STATE in the Name field, and then press F8 to execute the query.)
   3. Scroll to the BOOK_ASSIGN short value.
   4. Set the long value to Y.

      Note:

      When set to Y, RDC automatically assigns the DCI Book you defined as the default for the study to each patient when data is first entered for the patient.
   5. Save your changes.

Allowing Patient Book Assignments to Change

If you make use of a patient book assignment, you may expect the book assignment to change during the course of the study. The following are two examples where this may be the case:

• You define a new DCI Book to account for a protocol amendment. On a site-by-site basis, you update the Patient Positions table to assign patients to the new book.
• You use a Screening book for initial data entry, and based on responses in the Screening CRFs, you assign the patient to one of the arms (casebooks) of a multi-arm study.

To allow a change in the patient or book assignment:

1. Open Oracle Clinical.
2. Navigate to Admin, Reference Codelists, and then select Local Codelists.
3. Query for the OCL_STATE local reference codelist.
   1. Enter OCL_STATE in the Name field.
   2. Press F8 to execute the query.
4. Scroll to the BOOK_CHANGE short value.
5. Set the long value to ALLOW.
6. Save your changes.