Document Upload, Annotation, and Redaction

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1. Audits: Uploading of documents in the SDP to support a specific audit can be performed in the Audit Documents screen using the Document button. Verify the filter is set to the correct patient prior to uploading the patient case (see Figure 1).



Figure 1: Upload Document Feature in the Audit Documents screen

2. Central Monitoring: Documents are uploaded in the Expected Documents. Once in Expected Documents, click on the upload icon () in the action column. When uploading from the Expected Documents screen, the Document Details popup window will display with most of the filters along the top of the screen already fixed (see Figure 2); only Document Type will require selection. When using the Additional Documents feature to upload unexpected documents, all filters in the Document Details screen will need to be set manually by the user.



Figure 2: Filters at the top of Document Details screen.

3. CTEP-AERS: Uploading of documents in the SDP to support a CTEP-AERS adverse event safety report can be performed from the CTEP-AERS Ticket Details screen. Verify the filter is set to the correct ticket number prior to uploading the supporting documents (see Figure 3). Once in the CTEP-AERS Ticket Details screen, click on the upload icon () in the action column for the desired document type. If the document you are uploading does not match with the document types listed on the page, use the Additional Document button on the top right of the screen.



Figure 3: Ticket Number Displayed at the Top of CTEP-AERS Screen.

Special Notes about document type-related messages:

• Certain document types are only applicable to certain activities (e.g., audit packages should only be used for remote auditing); if you select one of those document types, you will get a pop-up message that you must accept before being able to proceed.
• Some activities (e.g., audit) allow the upload of duplicate document types for the same patient, although a courtesy warning will pop up (simply close the message to proceed). Other activities, however (e.g., central monitoring), require extra steps to upload a duplicate document type beyond the first expected document. For more information on how this works for a given activity, refer to the activity-specific Help Topics (e.g., instructions for remote auditing or for central monitoring).

1. The Add Annotation box that is checked by default in Figure 4 is described in the next sub-section, but its automatic application can be turned off by unchecking this box (it is recommended to leave the automatic annotation feature on). Annotation is described in the next sub-section, but its automatic application can be turned off by unchecking this box (it is recommended to leave the automatic annotation feature on).
2. The Auto Redact File box that is checked by default in Figure 4 is described in the sub-section below, but its automatic application can be turned off by unchecking this box (it is recommended to leave the automatic redaction feature on when uploading or replacing a document).
3. Once the filters are set, click on Choose File to select a document from your computer or network (see Figure 4). Note that file size and internet quality can affect performance during the upload process. A file size of less than 25 MB and fewer than 50 pages is recommended for the best results. Larger files may work but might require a long time for the SDP to process upon saving and final upload, and it is possible that the application could time out. If necessary, split larger files into smaller documents and ensure the internet connection is reliable before attempting uploads.

4. The document will appear in the window as shown in Figure 5 (note the automatic annotation in yellow at the top left of the document).

The default setting within the SDP upload screen is to automatically apply an annotation to every page of an upload; this annotation will display the site, protocol, and patient (see the yellow box in Figure 5). Again, it is recommended to leave this default setting in place. The location of the annotation can be manually shifted if necessary by dragging it with the mouse (must complete separately on each page).

There are two options for managing annotations (see Figure 6), either editing the default annotation, or creating a new customized annotation:

1. Revise the pre-existing annotation (i.e., the yellow box) by double-clicking within the annotation box itself to create a cursor; this will allow editing of or addition to the current content. If necessary, manually expand the size of the text box to ensure all content is visible.
2. Alternatively, create a brand new annotation by clicking on Annotate, then use the plus-shaped cursor to draw a box on the page. Type the desired content into the new box (see red text in Figure 6).

In either case, the updated or new annotation will only appear on the page where it was managed; it will not be copied to every page in the package.

In general, documents uploaded to and stored on the SDP should be free of personally identifying information (PII). However, when necessary (e.g., for the purposes of allowing auditors to confirm that uploaded documents are connected to a particular study subject), it is allowable to leave the subject's date of birth (DOB) and initials (not full names or signatures) unredacted; all other PII must be redacted. Any required redaction can be accomplished prior to upload (e.g., by redacting paper documents using an opaque pen prior to scanning and upload), or within the application using the built-in redaction functionality as described in this section.

Auto-redaction tool: The Auto Redact File tool is checked on by default (see Figure 7) and will remove any and all personal identifiers that it finds including but not limited to DOB, initials, names, addresses, and medical record number).

1. When the Auto Redact File is checked, the tool will auto redact any PII on each page of the document during the document upload and display a findings window to the right of the document named Marked for Redaction (see Figure 8).
2. As noted in the Marked for Redaction box, redactions can be individually removed by clicking the “x” to the right of the selected redaction. This action must be taken prior to selecting the Redact All button; at that point they will be applied and unchangeable.
3. If after saving the redaction, it is determined there is under-redaction, it is best to use the document EDIT which allows access to the manual redact feature discussed next.

Manual-redaction tool: To activate the manual redaction, always make certain the auto-redact feature is unchecked (see Figure 7) and then proceed with redacting any and all personal identifiers as needed (e.g., full name, address, or medical record number).

1. Click the Redact button and draw the redaction over the desired content using the plus-shaped cursor. Pending redactions will show as open boxes with a red outline. HINT: If the font within the document is small, making precise redaction difficult, it may help to use the resizing tool to increase the size of the document in the viewer.

2. Apply all pending redactions by selecting the Redact All button at the bottom of the Marked for Redaction box (see Figure 8)

3. As noted in the Marked for Redaction box, redactions can also be individually removed by clicking the “x” to the right of the selected redaction. This action must be taken prior to selecting the Redact All button; at that point they will be applied and unchangeable.
4. Turn off the redaction feature by clicking the arrow tool next to the Redact button at the top left of the document window.

If there are multiple pages, review each page for necessary redactions first before selecting the Redact All button.

Once the uploaded document is ready, scroll to the bottom of the viewer window, verify that all necessary PII has been redacted and the Redact all button has been selected, then check the box certifying the document represents the original source material and hit Save to complete the upload (see Figure 8). As noted previously, if uploading a document type that has already been uploaded for this patient, a courtesy pop-up message will appear. Click OK to continue or Cancel to go back.

When using the redaction tool, the saving of any redacted items must be done prior to saving the document in the SDP. Clicking the Redact all button saves the redaction, clicking Save at the bottom of the document will permanently apply all annotations to the document. You will receive a confirmation that the document has been saved and will be brought back to the screen you started from.