Upload and store any documents for your study
Study designers can now include questions in forms that let other users upload relevant clinical documents during the study conduct period.
Uploading and storing documents at the subject level is important for studies that require visual evidence, such as tracking the healing of a wound. By allowing you to upload documents, you can collect, analyze, and review more data, creating a complete picture of each subject. With this new feature, you can now preserve these documents that contain important details, typically harder to collect in structured formats, such as in a form.
Before you work with this feature
No new permission or role is introduced along with this feature. However,
as a user manager in your study, you must ensure that the site staff and other
sponsor users fulfill the following conditions:
- They're assigned with the following permissions, as applicable: View Form Data for Subjects, Edit Form Data for Subjects, View Classified Subject Data Only, and Edit Classified Subject Data Only. Note that users don't require all of these permissions, but rather the specific ones that align with their intended responsibilities. These permissions let them view forms and upload documents at sites that they're assigned to, including documents that are data classified, as relevant to their role. For more information, see Clinical Data Collection permissions.
- If documents can only be uploaded as classified data, then you should make sure users are assigned with the appropriate data classification permissions to view and manage classified documents. For more information, see Specify data classifications for a study role.
Details for study designers
As a study designer, here's what's new in your workflow, if you want to
allow other users to upload documents to forms:
- On the Forms tab, within a form, when you select Add Question, you can now see the File Upload option.
- Upon selecting File Upload, you can fill-in this item's details just as you would for any other type of question. For example, you can specify a title for the File Upload question, specify a question hint, determine whether you want the item to be required hidden, or optional, and many more.
- You can also classify a File Upload question. Upon turning on the Hidden toggle, you can select a type of data classification to apply to the File Upload question.
- You can configure a File Upload question as read-only, but we don't recommend doing so. Configure a File Upload question as editable, since a read-only question does not allow any user to upload a document. If you need to apply any restrictions on the File Upload question, use data classifications to ensure that only certain users can upload documents.
- You can include a File Upload question in any kind of form, except for a Drug Reconciliation form. Also, you can include it in a question group.
- When it comes to predefined rules, the only rule you can configure for a File Upload question is the Auto-lock rule.
- You cannot configure a File Upload question as a coding question or specify Electronic Health Records (EHR) mappings for this type of question.
Details for site users and other sponsor users
As a site user, you may have to upload documents in your forms. As a
sponsor user, you may be able to upload documents for classified questions, as well.
- If your study allows it, you can upload documents in subject forms. Where a File Upload question is included, you see it represented by an Upload button and a distinctive instruction on what you can upload.
- If you cannot upload a file or don't have a file to upload, you can always mark a File Upload question with a data flag, as Not Done, Not Applicable, or Unknown.
- You can only upload a single file for each item in your form. For example, for an item labeled as "Upload supporting file of wound", you can only upload a single supporting file of the wound, not multiple.
- During the upload of the document, you can view the file's upload progress. You can cancel the upload or refresh your browser's page. If you cancel the upload of a file or you refresh your browser's page during upload, this failed upload attempt is not included in the application's audit trail. In other words, the application won't document this failed upload attempt anywhere in the User Interface (UI) or in reports.
- When your file upload fails for technical reasons, the specific failure reason is listed in the UI.
- You cannot modify subjects or forms while a file is uploaded.
- Once you successfully upload a file, you can preview it from the form and you can delete the file. When you successfully upload a file in the form, this is saved in the application's audit trail, and you can see details of the upload action on the Answer & Visit History sidebar.
- Upon deleting a file, you must specify a reason for this change. When you delete it, the file is not removed from the server's storage, it's just removed from the application. Any mention of a removed file is also cleared from the application. The only record of that file can be viewed on the audit trail in the Answer & Visit History, and any applicable reports.
- With the appropriate permission, you can sign, verify, freeze, lock, or raise a query against a File Upload question. If a new version of a document is re-uploaded, then the item or form associated with that document becomes unverified and unsigned.
- When a File Upload question is frozen or locked, you cannot upload or re-upload the file for that item.
Impact on custom JavaScript rules
If you're a rule designer, keep in mind that a File Upload question can be used as a query target and added as a rule variable, but it's not a valid target for calculation rules. The rule variable will store the question's identifier, which is populated when a document is uploaded; otherwise, it will be null.
Impact on reports and archives
The following reporting changes are introduced for this new feature:
Note:
Want to learn more about the detailed impact and limitations on CRF Submit archives and reports? Check Oracle CRF Submit Archives requests include uploaded documents!| Report | Type of change | Description |
|---|---|---|
| Annotated Case Report Form | New type of question included in the report | When a File Upload question is included in the study's design, a new row is included in the report with all of the design-related details of this question type. |
| Rules report | New type of question included in the report | When a custom JavaScript rule references a File Upload question, its question label is displayed on the Target Question column. |
| Subject Data Extract | New type of question included in the report | When a File Upload question is included in a study,
the following columns display data related to the question's
label:
|
| Subject Data report | New type of question included in the report | Whenever a File Upload question is included in a study, modified, or removed, its data is displayed on a new row for the following columns: Date & Time, Question Label, Type of change, and Value. |
| Subject Queries report | New row in report | When a query is raised against a File Upload
question, data associated with this query is displayed across the
applicable columns in this report.
The name of the file is displayed on the Value column. |
| Study Design report | New type of question included in the report | When a File Upload question is included in the study's design, a new row is included in the report with all of the design-related details of this question type in the Forms section. |
| Study Design dataset | Modified data element description |
When a File Upload question is included in a study's design, its label is displayed for the ITEM_NAME data element. |
| Subject Form Items dataset | Modified data element descriptions | When a File Upload question is included in a study,
the following data elements display data related to the question's
label:
|
| ODM-XML extract | Modified field description | In the Clinical data extract, the uploaded file's name is displayed in the Value field. |
Parent topic: Data collection