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.
- Design Supplies and Dispensation
- Design Clinical Supplies Forms
- 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.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
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)
Note:
Existing drug order forms which have been used for drug reconciliation are not affected should a study designer create a drug reconciliation form.Parent topic: Forms