Ready Room Operational Manual

System Requirements

Ready Room is a managed web application. It can be accessed via any current “evergreen” (continuously updated) web browser such as Chrome, Firefox, or Edge. Internet Explorer is not supported.

Accepting a Ready Room Invitation

When a user is first invited to become a member of an account and/or an inspection, Ready Room generates an email with a link. Click on the link to bring up the registration screen. If your account is managed by Ready Room, from this screen you will be able to set your display name, password, and time zone. If your account is managed by your employer, you can only set your time zone.

The invitation expires after one week. If it is not accepted by then, an administrator can send a new one. Users will not be able to log in without actively accepting an invitation.

Logging In

To login, visit the Ready Room application's home page, https://app.readyroom.net or any other Ready Room page. You can also follow the "Login" link present at the top of the Ready Room corporate website, https://readyroom.net.

If your account is managed by Ready Room, login with your username (email address) and password. Login sessions last until the browser is closed or you actively logout. However, you can make your session last for 60 days by toggling the Keep me logged in for 60 days setting on the login screen.

If your account is managed by your employer, that is, if you are using single sign-on, ignore the username and password fields, and instead click the button corresponding to your identity provider (currently one of Azure AD, Okta, or Duo). This will direct you to your corporate identity provider where you can login as normal, if you're not already logged in. Then you will be redirected back to Ready Room.

Resetting a Forgotten Password

Single sign-on users cannot reset their password in Ready Room.

For all other users, if you forget your password, click the Forgot Your Password? link from the log-in screen and enter your email address. If that address is in the system, an email will be sent with a link to reset your password. Follow the prompts to reset it and then log in again with your email and new password. The password reset link is valid for 24 hours, if you don't reset your password within this window, simply repeat the process to get a new link.

Changing Display Name, Password, and Time Zone

Single sign-on users cannot reset their password or display name in Ready Room.

While logged in to Ready Room, click your display name in the upper right-hand corner, pull down the menu, and select Profile.

To change your name or time zone, in the Profile Settings dialog box, enter the desired name or select the desired time zone and click the Update Profile button.

To change your password, in the Change Your Password dialog box, enter a new password in the New Password field. The new password must be at least 12 characters long. Confirm the new password in the Confirm New Password field, and then enter your current password in the Current Password field. Click Reset Password.

Roles and Personas

Roles

Ready Room features three different roles with different permission sets.

The Account Administrator role can invite other users, change user roles, deactivate users, change user metadata, create inspections, edit inspection metadata, and set user personas. The Account Administrator role also has all the permissions of the Inspection Team Member role, below. An Account Administrator can access and participate in all inspections, even those of which they are not members.

The Inspection Team Member role can participate in inspections, which includes generating requests, assigning requests, adding and changing request metadata, uploading documents, promoting and demoting requests in the workflow, filtering requests, generating reports, downloading documents, deleting requests, and deleting documents.

The Inspector role can see restricted view of released requests, download released documents, mark requests as completed, and use filters.

Personas

From within an inspection, the Account Administrator and Inspection Team users can adopt one of the following personas. Personas are not roles; with certain exceptions, personas do not change a user's privileges.

• Communicator
• Assigner
• Subject Matter Expert
• Ready Room Reviewer
• Inspection Host
• Scribe

The personas are intended to fulfill different parts of the inspection workflow. Typically,

• The Communicator captures requests from an Inspector.
• The Assigner assigns the request to the appropriate Fulfiller (Subject-Matter Expert) and, if desired, to a Reviewer, and promotes the request to the Fulfill column
• The Subject-Matter Expert fulfills the request by providing a formal response and/or uploading requested documents and then promotes the request to the Ready Room Review column
• The Ready Room Reviewer QCs the response and documents to ensure they are complete, fulfill the request, and do not communicate extraneous information, and then promotes the request to the Host Review column.
• The Inspection Host releases the response to the Inspector.
• The Scribe captures the substance of the discussion in the Scribe Feed.

To enable changes in responsibility and in inspection team configuration, the Communicator, Assigner, Subject-Matter Expert, Ready Room Reviewer, Inspection Host, and Scribe personas all have the same permissions and can change their personas at will (except to Observer or Restricted SME) by clicking on the Personas button towards the upper right-hand corner of the inspection board. Changing these personas changes the color of the Personas button and the color of the user’s avatar in the Presence window as a visual clue as to which column the user should be focused on; however, selecting one of these Personas does not prevent the user from using other parts of the board.

The Observer and Restricted Subject-Matter Expert are special personas that must be assigned by the Account Administrator. Inspection team members cannot change their own personas to Observer or Restricted SME from within the inspection.

The Observer persona cannot enter or change data, promote or demote requests, or enter chat. Observers cannot change their personas.

The Restricted Subject Matter Expert (Restricted SME) has privileges similar to a Subject Matter Expert, but can only see requests in the Assign, Fulfill, and Ready Room Review columns that have been assigned to them. The Restricted SME cannot see any other activity on the inspection board.

More than one person may be assigned the same Persona.

Note that Account Administrators can automatically see and access all inspections, but they can only change Personas in inspections for which they are a member. An Account Administrator can easily assign him/herself to an inspection.

Inspection Workflow

The typical inspection workflow is as follows:

• The Communicator captures requests from an Inspector.
• The Assigner assigns the request to the appropriate subject-matter expert and promotes the request to the Fulfill column.
• The Subject-Matter Expert fulfills the request by providing a formal response and/or uploading requested documents and then promotes the request to the Ready Room Review column
• The Ready Room Reviewer QCs the response and documents to ensure they are complete, fulfill the request, and do not communicate extraneous information, and then promotes the request to the Host Review column.
• The Inspection Host releases the response to the Inspector.

To enable changes in personnel and different inspection team configurations, the system permits inspection team members to adopt different workflows, if so desired. For example, for a smaller team, a Communicator could both capture requests and assign them. Requests could be promoted from Fulfill directly to Host Review, skipping the Ready Room Reviewer. The only parts of the workflow that are required are Generate Request and Release to Inspector.

For a larger team, multiple personnel could be assigned to each role, with responsibilities divided by subject area or by inspector. For example, if there were two inspectors, there could also be two Communicators and two Scribes – one for each inspector’s workstream.

If an inspection team member needs to leave the inspection for a few minutes, hours, or days, another team member can adopt that persona temporarily as a signal to the rest of the team that the new person is now fulfilling the responsibilities of the absent team member.

The Inspection Board

The inspection board is divided into five columns representing the stages of a workflow. The expectation is that tasks will move through each stage from left to right, although stages can be skipped and tasks can be moved backwards.

New tasks are positioned at the bottom of the first column, the Assign column. Ready Room supports drag-and-drop, and users can pick up a task and move it to any column except the last, Inspector Review. In addition, open tasks can be moved left and right via the buttons in the lower right of the task dialog. This is the only way to release a task to the inspector. Tasks can also be arranged veritcally. Vertical position has no special meaning to Ready Room, but can be used to infer priority.

Tab Interface

The inspection board has five pre-set views: Active, Staged, Mine, Deleted, and All. These are simply filters into a single board. The "Active" tab holds all tasks that are not staged (see below), while the "Staged" tab shows only tasks that are staged. The "Mine" tab shows tasks that are assigned to the current user, whether they be staged or active. The "All" tab shows everything (including deleted requests, which are rendered in gray and struck through). The numbers next to the tab name show the counts of the (possibly filtered) tasks in that tab.

Generating a Request

To generate a request, any inspection team member (except an Observer or Restricted SME) clicks on the purple New Request button (or types Alt-N); enters, at minimum, a short Title for the request; and clicks Submit. Ready Room assigns a unique identifier, starting with 1 for the inspection. The Inspector will be able to see the title after it is released.

The user can also enter the following optional information:

• Custom identifier. An identifier of your own. This must be unique to the inspection.
• Description. This can help provide more information about the request. After release, the Inspector will not be able to see this information.
• Requested by Inspector. This drop-down menu allows the user to select any inspector who is a member of the inspection. Where there are multiple inspectors, this helps the inspection team find requests from a single inspector.
• Labels. The Communicator can add any number of account or program-level labels.
• Hard copy requested. This checkbox is used to indicate if the inspector has requested a hard copy of a document.
• Staged request. This toggle button is used to differentiate a staged request (a document that has not been explicitly requested, but which is being sent through the workflow in anticipation) from other requests.

Request generation is visible in the request history.

The expectation is that requests made by an inspector are "active," (not staged) and are visible in the Active tab. While an inspection is ongoing most team members will be focused on the Active or Mine tabs.

Staged Requests

Ready Room allows users to stage anticipated requests so they are fulfilled and reviewed before the inspector asks for them. To stage a request, create it using the New Request button, and toggle the Staged indicator at the bottom of the request. (If you are already in the Staged tab, this toggle defaults to on.). If you accidentally create an active request, you can stage it with the "Stage" button in the lower left of the task dialog.

Staged requests can be found in the "Staged" tab. They are also visible in the "Mine" and "All" tabs, but not in the "Active" tab. It's expected that team members will put the staged requests through the typical workflow, except that staged tasks can not be released to an inspector. Accordingly, the staged tab does not show the "Inspector Review" column. To release a task, it must first be activated via the "Activate" button in the lower left. At which point it becomes visible on the Active tab and can continue through the workflow.

Assigning Requests

Requests can be assigned to any Ready Room user who is a member of the inspection, except observers. The Assigned To field becomes active as a “Fast Action” field at the top of the request as soon as the request appears in the Assign column. Click the drop-down menu, select the appropriate user, and click Submit.

When the task is moved to the Fulfill column, a notification email is sent to the assignee. By clicking on the request link in the email, the user, if logged in, is taken directly to the request.

When the assignee opens the request, the assignee’s name turns from black to green, to indicate that the assignee has viewed and is presumably working on the request

If a request is moved back to the Fulfill column by anyone other than the assignee, a new notification is sent to the assignee alerting them that request needs additional attention. In addition, the assignee's name is turned black again to indicate that they have not accessed the task since it was demoted. If an assignee demotes his/her own request, no email is sent, and the assignee’s name remains green.

Requests can be re-assigned by any inspection team member except Observers and Restricted SMEs.

New assignments and changes to assignments are visible in the request history.

Promoting and Demoting Requests

Any inspection team user except an Observer can promote or demote a request by clicking on the button at the bottom right of the open request that indicates the next or previous column, if any. Requests will appear at the top of the selected column. Restricted SMEs can only promote and demote requests from the Fulfill column that are assigned to them.

Alternatively, any inspection team user except an Observer or Restricted SME can promote or demote a request by dragging it to any column in the workflow except the Inspector Review column. To prevent the accidental release of a task to an inspector, requests must be promoted to the Inspector Review column using the button visible when editing.

Promotions and demotions are visible in the request history.

Editing Requests

Requests are divided into four components: Actors, Request, Response, and Notes. To edit a component, simply click on it to bring up the corresponding form, enter or change entries as desired, then click Save. Note that each editable component form has its own URL.

If more than one team member has a request open, the avatar of all remote viewers will appear floating to the left of the request. If a remote user is typing, an animation will appear under their avatar. If a remote user makes a change to the request, that fact is shown in a box floating to the right of the request and the request is updated immediately. Note, if a remote user updates data that the current user is in the process of changing, the current user won't see that change in place, though they will see the annotation to the right. Hover the mouse over an avatar to see the remote viewer's full name and email address.

Formal Response

In cases where the inspector asked for information (as opposed to a document), users may enter a response in the Formal Response field, including rich text features, which appear when text is selected. In cases where the request requires a long explanation, the user may click on the Full-Size Editor link to open a large editor; in this view, rich text features are arrayed at the top of the window. Buttons at the bottom allow the user to Close without Saving, Save and Close, or Save and Continue (in cases where the user needs to pause while constructing the response).

Uploading, Downloading, Viewing, and Deleting Documents

If the file or files to be uploaded are in the TMF, Ready Room will try and guess what section (according to the CDISC TMF Reference Model) of the TMF it's in based on the title of the request. You can see these suggestions by clicking on the "Toggle suggested TMF artifacts" link

Any inspection team user except an Observer can upload one or more documents to a request at any point after it appears in the Assign column. Restricted SMEs can upload documents only to requests in the Fulfill column that have been assigned to them. Open the request and either drag files to the file "drop zone" in the middle of the request, or click Select Files and navigate to the desired files. An indicator for each file will show upload progress, turning to green when completed. Names of uploaded files will be displayed at the bottom of the drop zone.

There is no limit on the number (or type) of files that can be attached to a request. However, to mitigate against network congestion, files will be uploaded five at a time.

Most file types (Office, PDF, images, etc.) can be viewed without downloading by clicking on the file name. Use the diagonal arrows in the upper right-hand corner of the Preview window to resize the window to full screen. Use the Escape key to return to Preview mode.

For requests in any column except the Inspector Review column, files may be renamed. Click on the Rename link next to the file, edit the name, and click the Rename button. File names must be unique in a request.

A file can be downloaded by clicking on the "Download" link in the list of files.

When an inspector downloads a (released) file, that fact is captured in the request history.

After a file is uploaded, it can be deleted by clicking the Delete icon next to the file name. Deletion must be confirmed.

File uploads, renames, and deletions are captured in the request history.

Comments

Any inspection team user except an Observer can add a comment to a request at any point after it appears in the Assign column by clicking in the Comments field, entering the comment, and clicking the Comment button. Restricted SMEs can comment only on requests in the Fulfill column that have been assigned to them. All users can view comments associated with a request. Comments are useful for exchanging information or asking for clarification about a request. Rich text is supported in comments.

@mentions are supported in comments. Mentioning a user will send an alert to their screen, add a notification to the notification panel, and send an email.

An icon on the front of the request shows the number of comments.

Comments are not visible to an inspector.

Labels

Any inspection team user except an Observer or Restricted SME can add a label to a request at any point after it appears in the Assign column by clicking the Labels icon that appears just above the title. This action displays a drop-down menu of any labels that have been pre-defined by an Account Administrator. Labels can be used to indicate priority, categorize requests, or flag requests that meet certain conditions. Labels are defined for the entire account. More than one label may be selected. Selected labels can be deselected.

Label colors appear on each request card. Any user can hover a mouse over the color, which displays the label text and the description.

Labels are not visible to an inspector.

Marking a Request as Completed

Any inspection team user except an Observer or Restricted SME can mark a task in the Inspector Review column as Complete. Inspection team members should do this only when Inspectors are not viewing documents via the Ready Room Inspector portal (for example, when inspectors insist on reviewing paper documents). Open the request and toggle the Complete button in the upper right-hand corner to the “on” position.

To reduce clutter, completed requests can be filtered out of sight.

Deleting Requests

Any inspection team member except an Observer or Restricted SME can delete a request by opening it and clicking the red Delete button in the bottom left-hand corner of the request, then clicking OK after the prompt, “Are you sure you want to remove this request?”

Deletions are visible in the request history.

Recovering Deleted Requests

Any inspection team user except an Observer or Restricted SME can recover a deleted request, including attached files, by clicking on the Deleted (or All) tab; opening the deleted request; clicking the Recover button in the bottom left-hand corner of the request; then clicking OK after the prompt, “Are you sure you want to recover this request?” The recovered request will appear in the same column on the Active tab.

Delivering Responses to Inspectors

Logged In Inspectors

When an inspector is logged into the system they get a limited view of the inspection, seeing only a simple list of released tasks. From this list they can view the title of the request and the formal response. In addition, they can click on a request to open it and view and download attached documents. Administrators can configure Ready Room to give inspectors view-only access to documents, that is, they cannot download them. By default requests are listed in order by their system ID. Inspectors can change the sort order, filter the board, mark requests as complete, and reject a request (thus sending it back to the inspection team).

Using Inspector Shared Storage (Box, OneDrive, Teams)

If an inspector is properly configured (see below), it is possible to send attachments and cover sheets directly to a folder on a shared storage server, such as OneDrive or Box.

Make sure the task is associated with a shared-storage-configured inspector. When the task is released to Inspector Review, you will be able to set a subfolder name to hold this task's documents. A new link will be visible in the file listing saying "OneDrive Upload" (or Box). Use that link to send individual files to the inspector's shared folder. In addition, you can send the cover sheet and an archive of all files and the cover sheet to the shared storage by clicking the appropriate items in the file list.

Without Using Shared Storage

To deliver a formal response to an inspector who is not logged in or using a shared storage service, team members (presumably the host or communicator) can click the "Cover Sheet" pseudo-file. This will generate and download a simple, inspector-friendly PDF rendering of the request. To deliver a request's supporting documents, click the download link on the Archive file item. This will generate a zip file containing the cover sheet and all attachments. Finally, in the upper right corner of the inspection board is an "Archive" button (with a zipper icon). Clicking that button will generate a Zip file containing the cover sheet and attachments of all released requests. Since it may take some time to generate this archive, an email will be sent to the requestor when the zip file is ready for download.

Communications

Users can chat or schedule briefings (video conferences) from the communications panel. Chat and Briefings are in their own tab.

Chat

Any inspection team member, except those with the persona of Observer or Restricted SME, can chat by selecting the chat tab and entering text into the text window below the chat message list. The enter key publishes the chat to the Team Chat window with the user’s name, a time and date stamp, and an avatar indicating the user’s current persona.

Users can use Shift+Enter while in the text window to create separate lines within a single chat. Rich text is supported in chat.

@mentions are supported in chat. Mentioning a user will send an alert to their screen, add a notification to the notification panel, and send an email.

Briefings

Briefings can be enabled or disabled by an admin from the inspection configuration screen. Users must have their time zone set correctly for briefings to work properly.

When enabled, all users can access briefings by clicking on the Briefings tab. This will show the most recent 36 hours worth of briefings in which the user is a participant. A numeric badge in the tab title will show the number of upcoming and ongoing briefings. If a briefing is ongoing or coming up, the user can click the briefing name to start the conference in place or in a new tab. If the user is not the host, they will have to "knock" to be let into the briefing. Once in the briefing, there are a wealth of controls for managing audio and video, screen sharing, chat and more. See the documentation from Whereby, our audio/video provider, for details. Note, not all Whereby features are currently supported.

All users except observers and inspectors can schedule a briefing by clicking the "Schedule a Briefing" button at the top of the panel. The user can give the briefing a name (required, but not unique), a start date and time (required, not in the past), and a duration (required). Team members can be invited by clicking on the team member's name. Once submitted, the briefing will be displayed immediately on the displays of all invited users.

The host (creator) of a briefing is able to edit and cancel the meeting. In addition, they have access to a public link that can be shared with non-team members. Please note, that anyone with this link can enter the briefing, though they will have to enter their name and knock before joining.

All participants, including the host, will receive an email when they are invited to a briefing or when the briefing is altered. The emails will have an iCalendar attachment for calendar integration (tested with Outlook and GMail).

Scribe Notes

Any inspection team user can generate a new Scribe Feed by clicking on the "New" button in the Scribe Notes panel at the bottom right-hand corner of the inspection board. The feed is automatically named “Notes for ,” but it can be renamed. The user’s persona does not have to be set to Scribe to enter scribe notes.

When first created, the feed automatically opens in an editable state. The scribe enters notes by typing into the notes window, which includes options for rich text formatting. A metadata panel shows the current scribe, date/time last updated, and the Scribe Notes panel with the other feeds. Ready Room automatically saves the text every few seconds. Ready Room describes shortcuts that can be used for rich text formatting, including generation of time stamps. The system also automatically generates a time stamp when Scribes start and stop scribing and when Scribe Feeds are deleted and recovered. The Scribe may type the “@” sign to generate a list of Ready Room users and select a user’s name, rather than typing a user’s name. Grammarly is integrated with Scribe Notes; the user may review and accept or reject suggestions on spelling, grammar, and punctuation. When the user is finished with scribe notes, they can click the "Done for Now" button as a signal to other team members that they are no longer responsible for that scribe feed.

Other users can view a scribe feed by clicking on the feed in the Scribe Notes panel at the bottom right-hand corner of the inspection board, which also shows each feed name, the current scribe (or “No one” if no one is currently working on the feed). If the feed selected is not currently being edited, it opens in a non-editable state with the button "Start Scribing" in the upper right-hand corner, and the user can click on it to start entering notes. If the feed selected is currently being edited by someone else, it opens in a non-editable state with the button "Take Over as Scribe" in the upper right-hand corner. After confirmation, the user can start entering notes, and the former scribe can no longer enter notes. This function would be used if the current scribe left the scribe notes without clicking "Done for Now."

Scribe notes are dynamically updated for viewers, refreshing every time the note is auto-saved. Consective blank-lines at the end of the document are elided from view. Viewers of scribe notes can enable Automatic Scrolling, which automatically scrolls the user's view to the bottom of the screen as the Scribe adds new content. Alternatively, users may turn off automatic scrolling to view one section of a scribe feed while another section is being edited.

Any inspection team user currently editing a scribe feed can delete it by clicking the "Delete" button. Deleted feeds are moved to the Deleted tab in the Scribe Notes panel, visible in the inspection board and from any scribe notes entry screen. To recover a deleted feed, locate it in the Deleted tab, click on it to open it, click the Recover button, and confirm. Users can still view deleted feeds, but red text indicates that they are deleted. Deleted feeds can not be edited until they are recovered.

Users can search scribe notes using full text search. Full text search understands English stemming (searching for "inspect" will also return "inspector" and "inspection), proximity, priority and so on. Fragments from the matching note will be displayed with the match highlighted.

Any inspection team user can print a scribe feed by clicking the "Print" button and then following the prompts to print to a printer or to .pdf. Any inspection team user can print all feeds from the Scribe Notes panel by clicking the "Export" icon next to the title Scribe Notes and following the prompts. Scribe notes printed as a batch will be grouped in the order of their appearance. This can be used to preserve a record of the inspection at the end.

Generating Reports

Current Status

Any inspection team member can generate a CSV report of the current inspection status by clicking on the CSV icon in the top right-hand corner of the inspection board. This generates a CSV file that downloads according to the method specified in browser settings. The report, easily opened using Excel, includes the system-generated identifier, custom identifier, request status, request title and description, date and time requested and released, inspector, assignee, and debrief notes.

Audit Log

Any inspection team member can generate a CSV report of all inspection activity by clicking on the file icon in the top right-hand corner of the inspection board. This generates a CSV file that downloads according to the method specified in browser settings. The report, easily opened using Excel, includes a full audit log of actions taken in the system, including the user, timestamp, description of the action, and values entered.

Table View

Any inspection team member can render a tabular view of the inspection board at any time by clicking on the "Table View" button to the left of the inspection tabs. This generates a view of all current requests as a table. Requests can be opened and modified in this view, but drag & drop cannot be used to promote or demote them. Instead you can use the promote/demote buttons available on every request.

The table view is especially useful because it allows users to sort data by values other than state and priority, such as by assignee, inspector, or ID, using the links in the column header.

Inspector View

Any inspection team member can access the Inspector View at any time by clicking on the "spy" button in the top right corner of the screen. This allows the user to see exactly what the inspector sees.

Filters

Any inspection team user can filter out requests on the inspection board by clicking the "Open Filters" tab found in the inspection bar at the top of the board, then entering criteria for one or more filters (ANDed together). Requests can be filtered by ID, Custom Identifier, Assignee, Reviewer, Inspector, Request/Description, Label, or Completed status. Filters are additive and persist until the criteria are removed. Filters apply across all tabs simultaneously.

The user can collapse the filter panel by clicking "Close Filters," the filters will persist with selected criteria displayed. With the filter bar open, click "Clear" to clear all filter criteria.

Similar filters appear in the Inspector View, but Assignee and Label are not present as these are not fields that are visible to the inspector.

Metrics

In the inspection menu bar, choose the "graph" button to see a variety of visualizations regarding the current and past state of an inspection, including request states, lables, and attachments. In addition, there's a cumulative flow diagram to help administrators manage inspection resources. There are also various metrics regarding the number of requests per team member and inspector and the time to complete a task.

An administrator can configure the number of hours after which an in-progress task is considered delayed or late. When a request exceeds the delayed value, the time of creation in the lower left turns orange, when a task is late, it turns red.

Each column header displays the number of requests in that column and the total number of files attached to those requests.

The inspection's title bar contains three simple metrics: the total number of requests, the total number of attachments, and the average time it took to move a request from creation to release, i.e., the mean time to release.

All of these metrics respect the current filters, changing as the visible tasks change.

Inviting Account Members to the system

Account Administrators can invite users into the system by pulling down the Admin menu in the top left-hand corner of the screen and selecting Users. The admin can then enter one or more email addresses, and click Invite. Email addresses can be separated by commas, spaces, semicolons, or new lines. After adding users, to make someone an Administrator, click the Edit icon next to the user’s name and select Administrator.

Account members can be from any organization; CROs, labs, vendors, etc. Their email address does not have to belong to the domain associated with your account.

Locate a user quickly by filtering for Name, Email, and/or Active status in the filters at the top of the user list. Columns may be sorted by clicking on the column header.

Inviting Inspection Team Members to an inspection

To assign a user to an individual inspection, the Account Administrator accesses the inspection and then clicks the People icon near the upper right-hand corner of the inspection board, which displays the Members page. The Account Administrator then enters the user’s email address and clicks Invite. Users can be created in bulk by adding email addresses separated by commas, spaces, semicolons, or new lines. New team members do not need to already be Ready Room users.

If a user has previously accepted a Ready Room invitation, an email notification of the inspection assignment will be sent. The user is not required to accept it this notification; the inspection will automatically appear in the user’s inspection list.

If the user has not yet received a Ready Room invitation, the assignment will trigger an email invitation. After it is accepted and the user’s credentials are established, the inspection will appear in the user’s inspection list.

Team members (who are, of course, also account members) can be from any organization: CROs, labs, vendors, etc. Their email address does not have to belong to the domain associated with your account.

Creating Inspectors

An Account Administrator creates an inspector account from within an inspection by clicking on the "People" icon near the upper right-hand corner of the inspection board. From the Members page, the Account Administrator clicks the "Add an Inspector" button. This brings up a dialog box where the Account Administrator adds a name or alias for the inspector, which can be seen by the Inspector. The dialog box prompts the Account Administrator to note the generated username and password, which the Account Administrator will provide to the Inspector according to company procedures. Anonymized credentials are used for Inspectors to allay privacy concerns.

Editing Inspectors and Configuring Shared Storage

At any time you can change the inspector's name, time zone, or password.

Individual inspectors can also be configured to allow uploading documents to a shared storage service, such as Box or OneDrive. For this to work, the inspector must use the service's user interface to share a folder with an inspection team member. Paste that folder URL into the first field and click the "Update Folder" button. If successful, the step number will change from orange to green. The person with whom the folder was shared must now click the "Grant Access" button. This will send you over to the service, where you must grant Ready Room access to this folder on your behalf. You will be notified if both steps complete successfully. If not, you may change the folder URL or retry granting access as often as necessary.

Managing Inspection Team Members

Various tasks are available to Account Administrators from the Team Members screen.

• As noted above, Admins can set or change a user's persona
• If a team member has not yet accepted an invitation to the system (not inspection), the invitation can be resent by clicking the envelope icon. If no envelope icon exists, that means the user has already accepted an invitation to Ready Room.
• Team members can be deactivated and activated via the toggle button in the Active column. Inactive team members cannot access the inspection. This can be useful to manage inspector accounts; deactivating them at the end of the day and reactivating them the next morning.
• Users can be permanently removed from the inspection (but not the account), by clicking the red user-minus icon.
• The member list can be filtered and sorted by clicking on column headings.

Managing Account Members

Various tasks are available to Account Administrators from the Admin/Users screen.

• If an account member has not yet accepted an invitation to the system, the invitation can be resent by clicking the envelope icon. If no envelope icon exists, that means the user has already accepted an invitation to Ready Room.
• Account members can be deactivated and activated via the blue toggle button in the Actions column. Inactive team members cannot access any part of the account (though they can still access other accounts they may have access to).
• Users can be permanently removed from an account and all associated inspections by clicking the red user-minus icon.
• A users name and role can be changed by clicking the blue user-pencil (edit) button.
• The user list can be sorted by clicking on the column headings.
• The user list can be filtered by filling in a filter field and clicking Filter.

Creating an Inspection

An Account Administrator creates a new inspection from the main Program page by clicking the New Inspection button associated with the desired inspection. Enter an inspection name, inspectee name, planned start date, and indicator as to whether the inspection is an actual inspection, mock inspection, or training inspection, and then click Submit.

Edit inspection metadata by clicking on the Edit icon in the main account page and changing and resubmitting the data. Inspections can be moved from one program to another via this screen by selecting a new program.

Closing an Inspection

An Account Administrator can close an inspection from the inspection index, edit, and config screens. A closed inspection remains accessible but is no longer editable. Any user who was already a member of a closed inspection can still access that inspection, download files, review tasks, etcetera, but all changes are disabled.

Creating Labels

Labels allow you to tag requests and storyboards. These tags can be used in filters or to visually convey additional information. Labels can be created at the account level or the Program level. Account-level labels are available across all inspections and storyboards, while program-level labels are limited to that program's inspections and the program's associated storyboards.

An Account Administrator can define account-level labels by pulling down the Admin menu in the upper left-hand corner of the screen and selecting Labels. Program-level labels are created by clicking the "tag" button in the upper right hand corner of the inspection or from the "Labels" link when viewing a program. The process of managing labels is the same. In the Manage Labels page, add a label name and description (if desired) and then choose a color (note that color pickers differ by web browser), then click Create.

Edit a label by selecting it in the Existing Labels list, modifying the data, and clicking Update. Delete the selected label by clicking the Delete button.

If a deleted label has been used in an inspection, it will be removed from all associated requests.

You cannot create an inspection-level label with the same name as an already existing account-level label.

Storyboards

An Inspection Team member can generate one or more storyboard frameworks by clicking on the Storyboard icon (grid of squares) in the upper right hand corner of the inspection screen or by clicking the Storyboards link at the top of a Program.

From the Storyboards screen, pull down the New Storyboard menu and select the desired type. Process, Problem, and Role and Responsibility storyboards generate frameworks for describing a process, problem, or a team member’s role and responsibilities. Text in the framework can be edited, added to, or overwritten using rich text formats.

Select "Initialize with Expected GXP Questions" to generate a set of GCP or GMP or GVP inspection questions drawn from FDA, MHRA, and EMA guidance for inspectors and inspectees. All frameworks can be imported to the inspection, or key frameworks can be selected. Each framework include references to applicable guidance and can be edited using the same rich text tools.

Other metadata allows each storyboard to be assigned to one or more users and differentiate storyboards by protocol and site. Account- and Program-specific labels can also be applied. Supporting documents can be uploaded.

Grammarly is integrated with Storyboards; the user may review and accept or reject suggestions on spelling, grammar, and punctuation.

When editing a storyboard, all changes will be saved automatically.

Prior to an inspection, interviewees can pull down the Rehearse menu to rehearse all storyboards, assigned storyboards, or any other subset. The system presents each storyboard in flash card mode so interviewees can practice responses and then flip the card to view the content.

During an inspection, if an inspector asks about a storyboard topic, the storyboard can be located through the search and filter tools, then generated as an inspection request by clicking the Create Request button. The question, labels, and attached documents will be copied to the request, which can be edited before release.

A list of storyboards with metadata can be exported to a CSV file via the Export button or printed to PDF with the Print button.

Select the "Copy selected to…" menu to copy selected storyboards to the current inspection or any other inspection for which the user is a member. Note that Account Administrators can automatically see and access all inspections, but they can only copy storyboards to inspections for which they are a member.

Storyboards can be deleted individually or in bulk. Deleted storyboards can be recovered.