Please note: A PDF version of this guide is available for download at the bottom of the article.

Various types of documents can be attached to a study application. Such documents can be added, revised, archived or deleted by study side personnel who are assembling the initial submission packet, as well as by board members during their review. Board members can also assign a document outcome (e.g. Approved, Void) where applicable.

Document Processing in Previous Versions

Previously, document processing pages and popups on the study side differed from the same pages and popups on the board side, and all versions of all attached documents were stored in a single, comprehensive list on each side and under each board. The document lists could get very long for applications with many attachments and numerous revisions, deletions or document status changes.

Under some circumstances the documents could get out of synch. For example, version 3.0 of a Consent document could be attached to the application under IRB One, but IRB Two could have version 2.0 of the same document. When this error occurred, it was difficult to catch in the lengthy document lists.

Finally, document attachment was a multi-step process requiring numerous popup prompts to drill down to the specific type of document to be attached.

The new document management dashboard addresses these issues while providing a more intuitive document management interface.

New: Document Management Dashboard

Beginning with version 11.02.01 of iRIS™ a central dashboard page for document upload and management is provided for each major type of document as configured by the institution. Most institutions use Consent and Other Study Documents document types, but some have additional document types configured.

The screenshot below demonstrates an institution with four major document types configured, and therefore four document management dashboards: Informed Consent Master, Informed Consent, Other Study Documents and Contract Documents.

The new dashboard pages are shared across the study submission and board sides of processing, as well as across review boards, ensuring that all personnel at all stages of submission processing have visibility of, and access to, the same versions of attached documents at all times. As shown below for the Other Study Documents type, each new dashboard contains a tabbed list table.

Note that no Study Contract, Master Consent or Informed Consent documents are shown in the list above. This is because the dashboard shown is for Other Study Documents.

Below, page controls and elements of the new dashboard are highlighted with color coding. Notice that there is no Folder View button, as folder view is the default in the document management dashboard for any document with more than one version.

Note that full details of document processing steps are provided later in this manual.

Black Box / Arrow — NEW Create a Revised Document column, added to the All tab only; where it is possible to create a revision, the usual two pages icon ( )displays in this column; users can now click this icon to create a revision instead of going out to the document and checking it out to create a revision; see the Processing Example section of this manual for more information

Purple Box — document filter/search form for the list displayed at the bottom of the page

Purple Arrow — category type filter for the applicable document type (in this case the list contains categories applicable to Other Study Documents), limited to types in use on the study

Blue Box / Line — select checkbox(es) in the far-left column for document(s) to be archived, then click the Archive Selected Document(s) button to add the document(s) to the Archive tab

Orange Box / Line — select checkbox(es) in the far-left column for document(s) to be permanently deleted, then click the Delete Selected Document(s) button to delete the document(s), and add them to the Removed from Use tab if at least one review has occurred

Yellow Box — documents assigned an outcome of Approved or Void are added to the applicable tab

Dark Red Box — tabs to access lists of all documents associated with the study application/submission packet, filtered by document outcome or status (see table below)

As shown in the screenshot below, the new tabbed document management interface is the same for Consent forms, with labels updated to “Consent” where applicable. The Select a Category dropdown list is limited to categories applicable to Consent documents.

Notice the NEW Create a Revised Document column, added to the ALL tab only; where it is possible to create a revision, the usual two pages icon ( )displays in this column; users can now click this icon to create a revision instead of going out to the document and checking it out to create a revision. See the Processing Example section of this manual for more information.

As shown in the screenshot below, the new tabbed document management interface is the same for Contract documents as well, with labels updated to “Contract” where applicable, though the new Create a Revised Document column does not appear for this document type.

This page includes a Select a Contract Type dropdown list in its search form instead of a Select a Category dropdown list. Also, Contract Type is specified beneath the document Title in the list table instead of Category.

IMPORTANT NOTE: while user interface(s) for document management are different, with one exception, underlying document processing functionality and procedures are not. In other words, while the path of clicks followed to add a study consent revision is different for example, the underlying form and process used to add the revision are unchanged.

The one exception is document outcomes, which are now assigned on the view/edit page for each document type instead of using a separate approval/outcome page. This change is detailed later in this manual.

Where a given page control or element is not addressed in this manual, its functionality is either unchanged from the deprecated page or is self-explanatory. See the applicable Submission Processing manual for details of existing document processing functionality.

Page Changes: Study/Research Side

The screenshot below maps page elements from the deprecated document area on the study/research side to the new document management dashboard on the study/submission side. Note that while the pages shown are for the Consent document type, the same general mapping applies to other document types.

Notice that the Create a Revised Document column shown in the deprecated screenshot no longer appears in the new dashboard; this function is now accessed via the applicable Add a New [document type] and Add Multiple (where in use) buttons. See the Add New Document section of this manual for more information.

Blue Box – search/filter form for the document list at the bottom of the page

Green Boxes – buttons whose names and functions are unchanged

Orange Boxes – the Add a New [document/form type] and Create a Revised Document functions in the deprecated page are both accessed via the Add a New [document type] button in the new page; after clicking the button the user is prompted to either select an existing document for revision or add a new document

Yellow Boxes – document list for the selected tab; in the screenshot above the All tab is selected

Page Changes: Board Side

The screenshot below maps page elements from the deprecated document area on the board side to the new document management dashboard on the board side. Note that while the “New” screenshot shown is for the Consent document type, the same mapping applies to other document types.

Notice that the Create a Revised Document column shown in the deprecated screenshot no longer appears in the new dashboard; this function is now accessed via icons in the Create a Revised Document column where applicable. See the Add New Document section of this manual for more information.

NEW Cyan (light blue) boxes — create a revision; a new Create a Revised Document column has been added to the ALL tab; users can now click the icon in this column (where one

Blue Boxes – compare document versions: select the applicable checkbox(es) in the far-left column of the document list area at the bottom of the page to add documents to the comparison, then click the Compare document versions button

Orange Boxes – Add a New [document type], add a new document of the applicable type; as shown on the deprecated version in the screenshot above, the institution has the option to include an Add Multiple Documents button by setting the property system.allow_modify_documents_from_list to “Yes”, and this option is still available in the new document management dashboard

Red Boxes – delete documents

New: Submission Components Tab Icon Changes

The Submission Components tab is now updated to make the attachment of documents and creation of revisions consistent across the system.

Notice the icons in the Revise/Attach column in the screenshot above.

Previously, when a document was attached to the submission it had the same icon as that shown in the Revise/Attach column in the screenshot above (two pages icon) ONLY if the attachment was read-only. Now, the two pages icon displays in the Revise/Attach column for the highest/most recent version of ANY attachment, regardless of whether it is read-only or editable as long that component doesn’t have a higher revision that is currently editable.

Previously, when a document was still editable no icon would appear for it in the Revise/Attach column. The user would have to open the document and check it out to make any applicable revisions and attach it to the submission. Now, where an attachment is still editable the system still shows the option for the user to make a new revision and attach it to the submission. If the document attached has a higher revision, and the latest version of the document is editable, the system displays the paperclip icon.

Processing Example

The following example demonstrates the new paperclip icon.

Click the Add New Component button. As shown below, the Select an attachment type popup prompts for selection of an attachment type. For this example, click the radio button for Other Study Document to select it.

As shown below, the Attach Study Document(s) page opens. For this example, click the Add a New Document button.

After the document is added (see Study Document Processing section of this manual for more information on processing documents) it includes the two pages icon in the Revise/Attach column. As shown in the screenshot below, tip text explains that the user clicks this icon to create a revision. The same icon as before appears in the Unattach column, indicating the new attachment can be removed from the submission.

For this example, click the two pages icon to create a revision. As shown below, a confirmation popup displays.

Click the CONFIRM button to proceed. As shown below, the Study Document Revision popup opens for creation of the revision.

Complete the form as desired and click the Save Document button. As shown below, the revision is added to Submission Components with the two pages icon. The original version is listed as well, with no icon. This is because a newer version of that attachment now exists, and only the most recent version can be revised from this area.

For this example, click the icon in the Unattach column for the most recent version of the new attachment.

As shown below, the prior version remains and now has a paperclip icon in the Revise/Attach column. This is because this document has a new version and that new version is the highest and is editable. If the highest version were read only, then a Revise/Attach icon would be shown here.

Document Management Setup and Configuration

Certain system administration configuration steps must be completed to ensure proper functioning and list population of document management dashboards.

Property Settings

When displayed in the document management dashboard pages, the Removed from Use tab displays a filtered list of documents attached to the study application that had at least one round of review and were subsequently deleted. These documents can be viewed or printed, but they cannot be edited or revised.

When viewed from the study side, all such documents are displayed in the Removed from Use tab. When viewed from the board side, all such documents except those deleted by the board are displayed in the Removed from Use tab; the board does not see board-deleted documents deleted on that tab.

This tab does not appear in the dashboards by default. To make the Removed from Use tab display (as shown below) for a given module, set the property rb.allow_delete_auto_removed under Review Board Administration > Board Configuration Options > Submission Review Properties to “Yes” for the module. Repeat this configuration step for every module in use.

As demonstrated below, the institution has the option to include an Add Multiple Documents button on the Other Study Documents dashboard by setting the property system.allow_modify_documents_from_list under System Administration > System Configuration > Study Document Screen Setup to “Yes”.

When the Add Multiple Documents button is clicked, the Study Document Add Multiple popup opens.

List Maintenance Configuration

Documents assigned an outcome of Approved or Void are automatically listed on those respective tabs in the document management dashboard. Similarly, documents that have had at least one round of review and are subsequently deleted are automatically listed on the Removed from Use tab, and archived documents are listed on the Archived tab.

Where the institution wants to assign and track custom document outcomes within the larger Approved and Void outcomes, certain configuration lists must be populated at the system and module level to ensure the custom outcomes are properly listed on the Approved or Void tab of the dashboard, as the institution wishes.

System Level

Custom document category and subcategory (where applicable) lists must be configured at the system level to ensure proper document classification and pick list population on the document management dashboard.

Study Document Category

Navigate to System Administration > List Configuration and Maintenance > Site List Setup > Study Document Category link.

The Study Document Category page opens, as shown below.

Configure document categories as desired. See the System Administration manual for more information about configuring system lists.

Module Level

Module level list configuration changes are required to control the order of tabs on the document management dashboards, as well as to dictate which custom document outcomes are mapped to the Approved tab and which are mapped to the Void tab.

Study Document Outcome/Outcome Configuration List

Navigate to [module name] > Review Board Administration > List Configuration and Maintenance tab > Study Document Outcome / Outcome Configuration List link. In the example below, the Second IRB module is selected.

The Setup Study Document Outcome page opens, as shown below. Click the Add a New Status button.

An add panel opens for creation of the outcome, as shown below.

Additional fields populate in the add panel when “Yes” is selected for Create PDF, as shown below.

An example of the filled add panel is shown below. Click the Save Study Document Outcome button to save the outcome and close the add panel.

The outcome is added to the list on the Setup Study Document Outcome page, as shown below.

Repeat this process for all desired document outcomes. An example of a full list of custom outcomes is shown below.

IMPORTANT NOTE: the system administrator must ensure the list of study document outcomes is the same for every module where the document management dashboard is in use. Failure to maintain identical document outcome lists across modules will prevent the document management dashboards of other review boards from updating when a given review board assigns a document outcome or status change.

Study Dashboard(s) Tab Allocation

Navigate to [module name] > Review Board Administration > List Maintenance Setup tab > Study Dashboard(s) Tab Allocation link.

The Study Dashboard(s) Tab Allocation page opens, as shown below.

Notice the Select the Dashboard to Configure dropdown box at the top of the page, expanded in the screenshot below. The page loads with “Other Study Document Dashboard” selected by default.

Recall that there is a separate document management dashboard for each major document type set up in the institution’s iRIS™ system, and tab allocations must be completed for each dashboard. Click in the field and select the desired dashboard from the list to configure it. The example above shows the Study Dashboard(s) Tab Allocation page for the IRB module with the “Other Study Document Dashboard” open for configuration.

Enter the numerals one (1) to five (5) in the Order column to specify the order in which the tabs should appear on the selected dashboard for the applicable module (from left to right), then click the Save Tab Order button.

Click on the icon in the Edit column to assign custom document outcomes to the Approved or Void tab in the selected dashboard for the applicable module. An add/edit popup with a list of custom outcomes opens, as shown below.

The example above shows the add/edit popup for the Approved tab. Notice that the outcome of “Approved” is already assigned to the Approved tab by default. Similarly, an outcome of “Void” is already assigned to the Void tab by default when configuring outcome assignments for the Void tab.

Click to select the checkboxes of any other outcomes that are to be listed on the Approved tab of the document management dashboard for this module, then click the Save Associated Outcomes button.

Repeat this process for all document management dashboards for all modules, for both the Approved and Void tabs, ensuring that the same outcomes are assigned to the Approved and Void tabs across all modules.

Going forward, all custom document outcomes assigned to the Approved or Void top-level document outcome will appear on the Approved or Void tab, respectively (shown below).

IMPORTANT NOTE: the system administrator must ensure study dashboard tab allocations are the same for every module where the document management dashboard is in use. Failure to maintain identical tab allocations across modules will prevent the document management dashboards of other review boards from updating when a given review board assigns a document outcome or status change.

Study Document Processing

The following screenshots identify the correct page controls to use for various document processing functions in the new document management dashboard. See the applicable Submission Processing manual for details of underlying document processing functionality.

Add New Document

While separate add pages are provided for different document types where the data fields needed for those documents differ (e.g., document category options for contract documents differ from those for consent documents), the overall process of adding documents is the same regardless of type. See the applicable Submission Processing manual for full details of document processing functionality.

Locate and open the desired study. Click the applicable Protocol Items link to open the applicable document management dashboard. In the example shown below the Other Study Documents dashboard is open.

Click the Add a New Document button. Note that the button label may be customized on each document management dashboard (e.g., Add a New Contract, Add a New Consent, etc.). A popup opens for document category selection, as shown below.

Click to select the desired document category in the list.

A new section populates in the popup, as shown below. Click the radio button for “I want to add a new Document that has not been uploaded for this Study”, then click the Proceed with Document Upload button.

The Study Document Add popup opens.

Complete the fields in the popup and click the Save Document button. As shown below, the new document is added on the All tab of the Other Study Documents dashboard.

Add Multiple

As demonstrated below, the institution has the option to include an Add Multiple Documents button on the Other Study Documents dashboard by setting the property system.allow_modify_documents_from_list under System Administration > System Configuration > Study Document Screen Setup to “Yes”.

When the Add Multiple Documents button is clicked, the Study Document Add Multiple popup opens.

Multiple documents in various categories can be added to the dashboard using this form. See the applicable Submission Processing manual for details of existing document processing functionality.

Add Document Revision

The new document management dashboard allows for creation and tracking of revisions to existing documents.

Locate and open the desired study. Click the applicable Protocol Items link to open the applicable document management dashboard.

In the example below the Other Study Documents dashboard is open. Click the Add a New Document button. Note that the button label may be customized on each document management dashboard (e.g., Add a New Contract, Add a New Consent, etc.).

A popup opens for document selection. Click in the Please select the document Category dropdown list and select the type of document to be revised. All documents of the selected type that have been attached to the study are listed in the popup.

In the example below “Study Timeline” is the selected document type, and only one document of that type has been attached to the study.

Click the radio button for the document to be revised, then click the Proceed with Document Upload button. As shown below, an add panel opens for creation of the revision record.

The Document Title, Version Number, Version Date, Category and Description fields default to values taken or adapted from the existing, most recent version of the document, but all are editable. Make any desired changes, then click the Choose File button.

Follow the upload dialog prompts to upload the revision document.

Increment the version number of the document as desired, then click the Save Document button. As shown below, the new version is added to the All tab on the document management dashboard.

As indicated by red arrows in the screenshot above, the All tab is updated with the new revision number and a note is added to show which board created the revision.

Notice that a folder icon now appears in the View History column (blue arrow in screenshot above), indicating that more than one version of the document exists. Click the folder icon to expand history, as shown below.

Approve Document / Assign Document Outcome

In the new document management dashboard, the process of assigning an outcome to a study document is completed in the view/edit form for documents.

Locate and open the desired submission via the Submissions link in a board side module.

Click the Protocol Items link to open a dropdown list of available document management dashboards. In the example shown below dashboard links are available for Informed Consent, Other study documents and Contract Documents.

In the example below the Other Study Documents dashboard is open. In this example, version 8.1 of the Study Proposed Schedule is to be assigned a document outcome of Void. The process demonstrated in this section is the same for an Approved document outcome.

Click the icon in the Edit column for the document to which an outcome is being assigned.

As shown below, the selected document is opened in a Study Document Revision popup.

Select the desired Outcome from the dropdown list. In this example, Void is selected. Click the Save Document button to save the outcome and close the popup. As shown below, the Document Outcome is changed to “Void”.

Because an outcome of Void was assigned, this document is now added to the Void tab as well (shown below).

Notice that this tab does not include buttons to add new documents or delete existing documents, indicating a document with an outcome assigned cannot be revised or deleted. However, the Edit icon is still available so the document’s outcome can be changed if necessary.

Notice that because all document management dashboards are synchronized across modules, the Void tab for the Second IRB Other Study Documents dashboard (shown below) also includes the voided document.

When the system is properly configured according to the directions provided in the Document Management Setup and Configuration section of this manual, document management dashboard tabs remain synchronized across modules.

Archive Document

As the list of documents attached to a study lengthens, it may be desirable to archive documents that are no longer in use on the study so those documents will no longer appear in the All tab on document management dashboards.

Locate and open the desired submission via the Submissions link in a board side module. Click the Protocol Items link to open a dropdown list of available document management dashboards. In the example shown below dashboard links are available for Informed Consent, Other study documents and Contract Documents.

In the example shown below the Other Study Documents dashboard is open.

As shown above, select the document(s) to be archived in the far-left column, then click the Archive Selected Document(s) button. In this example the HIPAA Authorization document is being archived. A warning popup displays, as shown below.

Click CONFIRM to confirm the archive. As shown below, the archived document is no longer listed on the All tab of the Other Study Documents dashboard.

Click the Archive tab to view the archived document.

Note that this tab does not include buttons to add new documents or delete existing documents, though it does include an UnArchive Selected Document(s) button.

To reverse the archive, select the checkbox in the far-left column for the applicable document and click the UnArchive Selected Document(s) button. The document is removed from the Archive tab and added back to the All tab.

Notice that because all document management dashboards are synchronized across modules, the Archive tab for the Second IRB Other Study Documents dashboard (shown below) also includes the voided document.

When the system is properly configured according to the directions provided in the Document Management Setup and Configuration section of this manual, document management dashboard tabs remain synchronized across modules.

Delete Document

Personnel on either the study or the board side may wish to delete documents that are no longer in use on the study so those documents will no longer appear in the All tab on document management dashboards.

CAUTION: deleted documents are permanently removed from use and can no longer be revised or processed.

Locate and open the desired study. Click the applicable Protocol Items link to open the applicable document management dashboard. In the example shown below the Other Study Documents dashboard is open.

As shown above, select the document(s) to be deleted in the far-left column, then click the Delete Selected Document(s) button. A warning popup displays, as shown below.

Click CONFIRM to confirm the deletion. CAUTION: This action cannot be undone.

If the document to be deleted was created under a different module, a countdown warning like that shown below displays and the document is not deleted. Study and board personnel are only allowed to delete documents that were created under their own respective modules.

In the example shown below, the Second IRB Other Study Documents dashboard is open and the “Study Proposed Schedule” document is being deleted.

As shown below, the deleted document is no longer listed on the All tab of the Other Study Documents dashboard.

If the deleted document has gone through at least one round of board review, it is also added to the list on the Removed from Use tab (shown below).

Note that this tab does not include buttons to add, archive or delete existing documents, and all document details are presented as read-only when accessed via View or Edit links. Documents removed from use can only be viewed or printed.