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.

Logging In for the First Time

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.

This invitation expires after one week, but can be re-sent by the Account Administrator.

Logging In

For subsequent log-ins, go to the URL https://app.readyroom.net and log in with your email address and password as above. You can also access the log in from the company website, https://readyroom.net, from the Login link at the top of the home page.

Log in sessions last until the browser is closed. 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.

Re-setting a Forgotten Password

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 to with a link to re-set your password. Follow the prompts to re-set 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 and Password

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, in the Change Your Name dialog box, enter the desired name and click the Change Name 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.

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

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 Fulfill column that have been assigned to them. Requests are viewed as a simple list; 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:

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.

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:

Request generation is visible in the request history.

Staged Requests

Ready Room allows users to stage anticipated requests so they are fulfilled and reviewed before the inspector asks for them. The system visibly differentiates staged requests from other requests so that they are not accidentally released before they are actually requested.

To stage a request, create it using the New Request button, and toggle the Staged indicator at the bottom of the request. Staged requests display a “world” icon next to the assignee's name. It's expected that team members will put the staged requests through the typical workflow, then hold them in the Host Review column until they are specifically requested. In order to reduce clutter, you can use the Staged checkbox at the top of the Host Review column to hide staged requests.

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.

Each new assignment/reassignment to a new user triggers a notification email 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

When any request is demoted (moved to the left) 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

In the Assign, Fulfill, and Inspector Review columns, the most commonly-edited fields appear at the top of the opened request in a “Fast Action” section:

For any field that is not in the Fast Action section, click on the Edit button to bring up an edit form containing all the data, enter or change entries as desired, then click Submit. Note that the edit 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. Hover the mouse over an avatar to see the remote viewer's full name and email address.

Uploading, Downloading, Viewing, and Deleting Documents

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 four at a time.

There is a limit of 100 megabytes for a single file. Files dropped at one time must total less than 250 megabytes.

Most file types (Office, PDF, images, etc.) can be viewed without downloading by clicking on the file name.

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 and deletions are also visible 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.

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 de-selected.

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.

Alternatively, click the three horizontal lines at the top of the Inspector Review column to access the Inspector View, then toggle the Complete button to the left of the desired request.

To reduce clutter, completed requests can be hidden by toggling the Complete checkbox at the top of the column.

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 eye-slash icon in the upper right-hand corner of the inspection board; 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 at the bottom of the Assign column.

Delivering Responses to 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 view and download attached documents. By default requests are listed in the order they are released. Inspectors can change the sort order, filter the board, mark requests as complete, and hide completed requests.

To deliver a formal response to an inspector who is not logged in, team members (presumably the host or communicator) can click the "Cover Sheet" button on the bottom left of a released task. This will generate a simple, inspector-friendly, HTML rendering of the request that can be printed or saved as a PDF. To deliver a request's supporting documents, click the "Export" button. 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.

Chat

Any inspection team member, except those with the persona of Observer, Restricted SME, can chat by entering text into the text window blow 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 Control + Enter while in the text window to create separate lines within a single chat.

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 in order 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. 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. Users can view one section of a scribe feed while another section is being edited; viewers are not restricted to the scribe’s view of the document.

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.

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

Any inspection team member can generate a CSV report of inspection activity 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 imported into 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.

Table View

Any inspection team member can render a tabular view of the inspection board at any time by clicking on the icon with the three horizontal lines in the top right-hand corner of the inspection board. This generates a view of all current requests as a table. Requests can be opened and modified in this view, but you cannot use drag & drop to promote or demote them. Instead you can use the promote/demote buttons available on every card.

Inspector View

Any inspection team member can access the Inspector View at any time by clicking on the three horizontal lines at the top of the Inspector View column. This allows the user to see exactly what the inspector sees.

To return to the inspection board, use the browser’s back arrow, or click the Home icon in the upper left-hand corner and re-select the inspection.

Filters

Any inspection team user can filter out requests on the inspection board by selecting a filter type in the filter drop-down menu found in the inspection bar at the top of the board, then entering criteria for the filter. Requests can be filtered by ID, Custom Identifier, Assignee, Title/Description, Inspector, or Label. Alternatively, All can be selected, and the system will return any request that has the criterion in any of those fields. The filter persists until the criteria are removed.

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.

The inspection board filters work in conjunction with the column filters; staged and complete.

Metrics

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 Administrator users can invite other Account Administrators by pulling down the Admin menu in the top left-hand corner of the screen, selecting Users, and then clicking the Add a User button. The Account Administrator adds the intended user’s email address and selects the radio button for Administrator.

The Account Administrator can also use this method to add prospective inspection team users to the account, by following the same process but selecting the radio button for Team Member; however, a separate step is required to add these inspection team members to individual inspections (see below).

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.

Inviting Inspection Team Members to an inspection

To assign a user to an individual inspection, the Account Administrator access 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 adds the user’s email address and clicks the Invite button. New team members do not need to already be Ready Room users.

If the user has already previously accepted a Ready Room invitation, an email notification of the assignment will be sent, but the user is not required to accept it; 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. After the Inspector is created, the password cannot be retrieved or changed, but a new account can be easily created. Anonymized credentials are used for Inspectors to allay privacy concerns.

Managing Inspection Team Members

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

Managing Account Members

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

Creating an Inspection

An Account Administrator creates a new inspection from the main account page by clicking the New Inspection button. 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/resubmitting the data.

Creating Labels

An Account Administrator can define labels that can be used by any inspection associated with the account. Pull down the Admin menu in the upper left-hand corner of the screen and select Labels. 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.

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.

From the List 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 Questions" to generate a set of GCP inspection questions drawn from FDA and EMA guidance for inspectors. 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-specific labels can also be applied. Supporting documents can be uploaded.

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.

After the inspection, storyboard content can be exported via the Print button and printed to PDF.

Select the "Copy selected to…" menu to copy selected storyboards to 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.