About Drug Reconciliation forms

You use a Drug Reconciliation form to collect data related to kits in order to help site or sponsor users keep track of kits that have been sent for destruction.

A single drug reconciliation form design can be created per study. To design drug reconciliation forms, the following permissions are required:

• Design Supplies and Dispensation
• Design Clinical Supplies Forms

By default, the drug reconciliation form consists of a three-section template, which can be customized to fit the requirements of your study. The following sections are included in a form:

• A flat section, containing fields related to general study information.
• A repeating section, the fields of which will be populated with the information of the kits being reconciled.
• A flat section, containing information related to the target depot or the user who has requested the form.

Note:

The fields of a drug reconciliation form can only be moved within the same section, not between sections.

Drug reconciliation forms support the new Existing Data field. The existing data field self-populates based on existing study data, in order to reduce the number of fields sponsor and CRO users need to complete when performing drug reconciliation using drug reconciliation forms.

A single drug reconciliation form design can be created per study. As you design your drug reconciliation form, you can configure the following existing data fields:

Table 5-1 Existing data field types available for the first section

Field name	Notes
Instructional text	Included in the template drug reconciliation form. Can also be added to the third section of the drug reconciliation form. For more information, see Add instructional text to a form.
Protocol	Included in the template drug reconciliation form.
Site ID	Included in the template drug reconciliation form. Can also be added in the repeating section.
Site Name	Included in the template drug reconciliation form. Can also be added in the repeating section.
Investigator Name	Included in the template drug reconciliation form. Reflects the first and last name of the site investigator.
Study Name	Not included in the template drug reconciliation form.
Study ID	Not included in the template drug reconciliation form.
Study Mode	Not included in the template drug reconciliation form.
Depot Name	Not included in the template drug reconciliation form.
Depot ID	Not included in the template drug reconciliation form.
Depot Address	Not included in the template drug reconciliation form.
Main Primary Address	Not included in the template drug reconciliation form. Can also be added in the repeating section.

Table 5-2 Existing data fields available for the second section

Field name	Notes
Kit Number	Included in the template drug reconciliation form.
Blinded Lot	Included in the template drug reconciliation form.
Packaging Type	Included in the template drug reconciliation form. Can be bottle, inhaler etc., as input by the study designers when defining the kit type during study design.
Number of Units in Kit	Included in the template drug reconciliation form.
Text Field for CRA Comments	Included in the template drug reconciliation form. This field is only accessible during design.
Kit Description	Not included in the template drug reconciliation form.
Blinded Lot Expiration Date	Not included in the template drug reconciliation form.
Manufacturing Lot Expiration Date	Not included in the template drug reconciliation form.
Manufacturing Lot	N/A
Missing Units	Not included in the template drug reconciliation form.
Storage Temperature	Not included in the template drug reconciliation form.
Status	Refers to the status of the current kit. Not included in the template drug reconciliation form.
Subject ID	Not included in the template drug reconciliation form.
Screening Number	Not included in the template drug reconciliation form.
Randomization ID	Refers to the initial randomization ID. Not included in the template drug reconciliation form.
Randomization Date	Returns the randomization date added by site users. Not included in the template drug reconciliation form.
Returned Units	Not included in the template drug reconciliation form.
Visit Name	For cycle or unscheduled visits, the visit instance will be added to the end of the contents of this field. Not included in the template drug reconciliation form.
Visit Date	Date entered by users at the time of visit. Not included in the template drug reconciliation form.

Note:

Users will not be able to add additional rows, this section will display the kits that are selected.

Table 5-3 Existing data fields available for the third section

Field name	Notes
Target Depot ID	Included in the template drug reconciliation form.
Target Depot Name	Included in the template drug reconciliation form.
Form Generated By	Included in the template drug reconciliation form.
For Generated Date	Included in the template drug reconciliation form.

Other fields which can be added to drug reconciliation forms

In addition to existing data fields, the following can also be added to a drug reconciliation form design:

Table 5-4 Other fields

Field name	Notes
Signature	This field is designed to accommodate a wet signature, after the form has been generated and filled in by a sponsor and CRO user.
Signature Date	Entered manually.

Printing drug reconciliation forms

Due to the limitations of the PDF format, you can only print a maximum of 9 columns from the repeating section. Although you can create as many columns as necessary, each column will wrap when the form is saved as a PDF file.

Advanced study versioning (ASV)

To add a drug reconciliation form, you must update and go through the entire study versioning process, since ASV is not supported. To apply your changes, update your form in a Draft study version, assign the new study version to the impacted sites in the appropriate modes, and then move your study version to Approved.

Note:

Existing drug order forms which have been used for drug reconciliation are not affected should a study designer create a drug reconciliation form.