site user manual...20 minutes of inactivity. a pop-up will alert you one minute prior to logging you...

REGULATORY DOCUMENT MANAGEMENT AT ITS BEST

SITE USER MANUAL

A FULLY VALIDATED AND PART 11 COMPLIANT ELECTRONIC DOCUMENT MANAGEMENT SYSTEM FOR RESEARCH SITES, STUDIES AND PERSONNEL.

Version 4.3.1 www.realtime-ctms.com

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TABLE OF CONTENTS

Getting Started .................................................................................................................................................................... 5

Logging In ............................................................................................................................................................................ 6

Managing Users and Privileges ........................................................................................................................................... 8

Adding a Study .................................................................................................................................................................... 9

Assigning Delegates .......................................................................................................................................................... 10

eDOCS LITE vs Fully Activated eDOCS ............................................................................................................................... 11

General Navigation ........................................................................................................................................................... 14

Navigation of eDOCS ......................................................................................................................................................... 15

The eDOCS System ........................................................................................................................................................... 16

Study Progress Tab ............................................................................................................................................................ 19

MyDocs ............................................................................................................................................................................. 20

Study Organization ............................................................................................................................................................ 22

Supported Files ................................................................................................................................................................. 27

Adding New Records ......................................................................................................................................................... 28

eSignatures........................................................................................................................................................................ 30

Certified Copies of Original Documents ............................................................................................................................ 34

Document Options ............................................................................................................................................................ 37

Audit Trails ....................................................................................................................................................................... 38

Document Cart .................................................................................................................................................................. 39

Attach Signature Sheet ..................................................................................................................................................... 41

Read/ Write Notes ............................................................................................................................................................ 42

Message Monitor Reviewer .............................................................................................................................................. 42

Email Documents .............................................................................................................................................................. 43

View/ Share Download URL .............................................................................................................................................. 43

Move Document ............................................................................................................................................................... 44


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Document Visibility ........................................................................................................................................................... 46

ICF Tracking ....................................................................................................................................................................... 49

Subject Documents ........................................................................................................................................................... 58

Managing Monitor Portals ................................................................................................................................................ 59

Monitor Queries ................................................................................................................................................................ 62

Generating Reports ........................................................................................................................................................... 66

EDOCS ADMIN USER MANUAL

General Site Documents Template ................................................................................................................................... 68

Study Regulatory Documents Template ........................................................................................................................... 69

Personnel and Delegates Documents Template ............................................................................................................... 69

Organizing in eDOCS ADMIN ............................................................................................................................................. 70

Syncing a Template ........................................................................................................................................................... 75

Generating Admin Reports ............................................................................................................................................... 76

Customizing Signature Statements ................................................................................................................................... 77

Managing Archived Documents ........................................................................................................................................ 78


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BLANK PAGE


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INTRODUCTION: GETTING STARTED

RealTime-eDOCS™ is a fully validated electronic document management system. RealTime-eDOCS™ is designed to create efficiencies while meeting the requirements of 21 CFR Part 11 for managing electronic records. This manual will guide administrators and users through the set-up and implementation of RealTime-eDOCS™.

SYSTEM INFORMATION

RealTime-eDOCS™ is optimized for Google Chrome, Mozilla Fox and Microsoft Edge. If you are an Internet Explorer user, there is a minor change that needs to be made to the Internet Explorer options. You will need to go to Internet Options and locate the Tab options. Select ‘Always open pop-ups in a new tab’. Once this is done it should not need to be completed again for your computer.


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LOGGING-IN

RealTime-eDOCS™ is a web-based system. If your site is already a customer of RealTime-CTMS™, then you will log into the system using the existing URL for your CTMS (Clinical Trial Management System) and your existing username and password.

If your site is a customer of RealTime-eDOCS™ but not a customer of the CTMS, you will access the system by typing the URL: https://RealTime-host01.com/siteid. Your Site-ID is unique and will be provided to you during the implementation of your system. It is case sensitive and must be in lowercase. *It is recommended that you bookmark your RealTime-eDOCS™ login address within your browser for quick access to the system.

The RealTime-eDOCS™ login page will look like this:

Your login credentials require a specific username and password in order to access the system. Your username will consist of the first initial of your first name and your complete last name. Example: John Smith, Username = jsmith. You will login with a temporary password emailed to you for your first login. Once you have logged into the system, you will need to change your password. Your new password must contain at least 8-12 characters and must contain at least 1-capital letter, 1-special character, and 1-number.

Forgot Password/Failed Attempts

On a failed login attempt you will receive an alert that your login has failed. You will have five chances to login before you will be locked out of the system.

If you forget your password, click on the ‘Forgot Password’ link. You will be asked to supply your email address to request a temporary password. Check your Spam/Junk folders if you do not see the email in your inbox.


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If you get locked out of your account, you can send an email to your site’s administrator by clicking System Administrator or [email protected]. Clicking on any one of these options will open an email page with the contact information and subject line pre-filled for you.

Time Out

The system will automatically log you out after a certain time of inactivity (varies by site). Standard limits are 20 minutes of inactivity. A pop-up will alert you one minute prior to logging you out. Once the countdown has begun you will have two options to choose from: No, Log Out or Yes, Still Here. Clicking Yes, Still Here will reset the clock. If no action is taken, the system will automatically log you out and login screen will be displayed.

You will also see an alert in your browser’s tab.

Optimize Security

To optimize security and remain compliant with 21 CFR Part 11 regulations, please remember to:

1. Assign usernames that identify the person. Generic usernames (e.g., System Admin) make it difficult for

the system to assign individuals to the audit trail.

2. Never share user passwords.

3. Never email passwords or write them down.

4. Never allow browsers to save a username or password.

5. Never perform actions under someone else’s username and password.


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MANAGING EDOCS USERS AND PRIVILEGES

To learn more about adding/managing site users, please reference the RealTime-CTMS™ Administrator Manual located in RealTime University. This manual can also be obtained from RealTime-CTMS™ customer support.

EDOCS USER PRIVILEGES

Users will be assigned eDOCS privileges depending on their role. An administrator with the access to Manage Entities will assign user privileges. Note: Privileges specifically for eDOCS are listed as “Documents:”, all other privileges are for other RealTime products.

The following is a description of each eDOCS privilege:

Documents: Admin

• Allows access to eDOCS admin tab to manage site-level folders, documents, templates and document archives. This user can re-order, add/edit/delete folders and categories at the study level; move, view and manage documents for other users; and to view reviewer badges and notifications for queries for studies the user is assigned to.

Documents: Basic • Will allow users to view, edit, share and upload documents on

studies they are assigned to and send them for electronic signature.

Documents: Archive • Allows the user to archive documents. The user will not have the

ability to restore archived documents unless they are Admins.

Documents: View Contracts and Budgets

• Allows access to view and manage documents under the Contracts and Budgets category at the study level. This privilege is not included in Admin privilege access.

Documents: Manage User Documents

• Allows users access to the My Docs area of site staff to be able to manage documents without having full admin privileges to other areas. Previously this privilege had to be combined with the Admin privilege and this is no longer required.

Documents: General Site Documents

• Provides user access to the eDOCS Admin Section but only show General Site Documents. This will allow users to manage, view, share and upload General Site documents but they will not have access to the rest of the admin area.


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Documents: Manage Study Contact Login

• Allows user the ability to issue monitor portals by setting usernames and passwords for reviewers. All of which is managed from the Study Contacts section under the General Info tab within the study.

Please note: General users who do not have an eDOCS privilege assigned, will only be able to view and share documents on the studies that they are assigned to, but will not be able to upload records.

Monitors/CRAs are granted remote access through the General Info section of each study under the Study Contacts section. For more details on managing monitor portals, see the section titled Managing Monitor Portals.

ADDING A STUDY TO THE REALTIME SYSTEM

An Administrator can add new studies to the system using the Manage Studies tab. Enter all relevant information on this page and click the Add This Study button located at the bottom of the screen. The study will then populate under the Home Page and allow staff to upload records.


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ASSIGNING DELEGATES TO MANAGE STUDIES

RealTime-eDOCS™ makes it easy to assign delegates to a study. For example, if a site needs a user to receive study notifications but does not need to be listed as a study delegate for a particular study, this feature allows for this to be set up. Also, the opposite can be set up where a user is listed as a study delegate but will not require study notifications. Both items can be activated if the user is a study delegate and also requires study notifications.

The Administrator will visit the Manage Studies tab and select the appropriate study. From the Authorized Users section, users will have the ability to control which individuals will receive granted access to the study, including study notifications. Also, individuals can be listed as a study delegate allowing the user’s MyDocs to file into that particular study automatically. On the right side of the screen, a list of available users will be provided.

Simply select the individuals assigned to this study. Selected individuals will move to the left side of the screen.


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Once the appropriate users have been authorized and assigned to the study, an Administrator can now control which individuals will receive study notifications and which individuals will be listed as a study delegate by

clicking on the person and/or document icons .

The person icon , when activated, will allow the assigned user to receive study notifications and updates.

The document icon , when activated, the MyDocs of this user will be linked to this study.

Click the button to save the changes

EDOCS LITE STUDIES VS. FULLY ACTIVATED STUDIES

If your site is already a customer of the RealTime-CTMS™ system, then the site can take advantage of RealTime-eDOCS™ LITE for free and decide whether or not to fully activate/enable eDOCS for a particular study in their CTMS.


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In order to have full eDOCS with unlimited storage capacity, click the “Activate eDOCS” button and an email notification will be sent to RealTime to process the applicable fees. Once eDOCS is enabled, your site’s contracted eDOCS rates will apply. Users with the CTMS privilege Administration will have the ability to enable eDOCS.

RealTime-eDOCS™ LITE is a limited version of RealTime-eDOCS™. The only limitation of EDOCS LITE is the storage capacity that allows for only 150MB of data per study to be stored in the eRegulatory binder. To view

how much percentage is being used by each study, click on the gear icon if available, which will take you directly to Manage Studies.


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Once a user enables eDOCS within the CTMS system, activation details will appear to show users when eDOCS was activated.

eDOCS-ONLY CUSTOMERS

For eDOCS-only customers, your site’s contracted eDOCS rates will be applied once a study is added to the system, there is no eDOCS LITE version available.


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GENERAL NAVIGATION

*Note that Standalone eDOCS Customers will have a different view of the menu*

The Studies link will always bring the user back to the Home Page where their assigned studies are listed. Clicking the RealTime™ logo in the top left corner will bring the user to the Home Page also.

The Subjects link is used to search for a subject within the RealTime-CTMS database. Subjects may be searched by entering a portion of their first and/or last name, initials, medical record number (MRN#), date of birth, phone number, or email address. Each subject within the RealTime-CTMS database is assigned an MRN# with which they can easily be referenced. Before adding a new subject record in RealTime-CTMS, a subject search should be completed to prevent duplicate entries in the database.

The Contacts is used to search for and add study-related sponsor/CRO contacts. Sponsor/CRO contacts may be searched by entering a portion of their first and/or last name, company, or phone number. Contacts can be assigned to specific studies within the system and will show up under the General Information tab.

The Reports and My Tasks link are explained in the Reporting Tools section of the RealTime-CTMS™ User manual located in RealTime University.

The My Docs link will allow users access to their personal My Docs page. This page is used to upload and manage personnel training documents and qualification records such as curriculum vitae, medical licenses, GCP certificates, etc.

The Calendar link is explained in the Calendar section of the RealTime-CTMS™ User manual located in RealTime University. This manual can also be obtained from RealTime-CTMS™ customer support.

The University link will allow users to access a video tutorial page where they can watch videos covering all sections of the system. The videos are separated by User and Administrative Videos. The User Videos take approximately one hour to complete and will cover all topics discussed within this user manual.

The Administration link is only visible to users with system admin privileges.


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THE HOME PAGE

When users first log into RealTime™, they will be brought to the Home Page which lists all studies assigned to that user. If a study you are currently working on is not visible on your Home Page, contact your RealTime™ administrator to assign that study to your username.

GENERAL NAVIGATION OF EDOCS

RealTime-eDOCS™ will be accessed using the icon on the home study screen or eDOCS tab for each study.


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Documents Sections within eDOCS:

EDOCS SYSTEM ORGANIZATION

The eDOCS tab is divided into Sections, Categories, Folders and Records/Documents. Sections (i.e., Study Regulatory Documents, Personnel/Delegate Documents and General Site Documents) cannot be altered; however, the Categories and Folders within each section are fully customizable.

Sections


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Categories

Folders

Records/

Documents

EDOCS TAB

Once you click on a study from the Home Page, the eDOCS tab will display all records that have been uploaded to that particular study. eDOCS consists of three sections: Study Regulatory Documents, Personnel/Delegate Documents and General Site Documents.


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Study Regulatory Documents tab is the eRegulatory binder where the study specific documents are uploaded and viewed.

Personnel/Delegate Documents tab consists of user documents managed in the MyDocs area of the system.


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General Site Documents tab consists of site level documents managed in the eDOCS ADMIN within the Administration area of the system.

STUDY PROGRESS TAB

The Study Progress Tab allows the user to track milestones during the study (e.g., dates related to study startup, business development, regulatory activities, contracts/budgets, and recruitment dates). This section also allows users to send email notifications to their assigned study team when milestones are met.

In addition to tracking study milestones, the user can type custom comments/notes into the system. Once a comment/note is entered, the user will have the option to send an email notification alerting the study team of the note or schedule a follow up event that will be placed on the calendar as a reminder.


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GENERAL INFO TAB

The General Info tab displays study information as it has been input by RealTime-eDOCS™ administrators. Important study information such as Sponsor, Protocol Title, IRB, Investigators, Recruitment Goals, Study Contacts, etc. is displayed on this screen.

All study contacts (Monitor, Project Leads, etc.) should be added to the Study Contact section located at the bottom of the General Information page. This provides all users easy access to important contact information throughout the study. This section also becomes very important when creating monitor portals for sponsors/CROs to access study records. Maintaining a current list of study contacts is highly encouraged. Details on how this page can be managed can be found on page 57.

MY DOCS

Each user is provided with a My Docs section to manage personnel training and qualification records and can be accessed by clicking the link at the top of the webpage.

This section can be viewed as a central filing binder for professional documents, certifications and training records, also known as a Professional Education Training Tracking system (PETT System). Having a central location, such as this, allows the site to file records once rather than multiple times across studies. It’s important


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to create a standard process in which your site uploads documents to this section. A standard practice will ensure consistency across studies and staff while increasing efficiency when navigating records. RealTime-eDOCS™ provides a default template to get started quickly.

A few important questions to ask before getting started with the PETT system:

1. Does your site have a standard file naming convention that allows quick identification of saved records? If not, feel free to use the following: DocumentType_StaffName_ExpirationDate (i.e., CV_Dr.Seuss_Exp25Jan2016).

2. Does your site have a standard process for routing and uploading records into the PETT system? For example, some sites may prefer that each employee uploads their own training/qualification records while other sites may want to have a central person that uploads records for all staff members.

Users with the Documents: Manage User Documents privilege will be able to view and manage all user My Docs sections. To access a user’s My Docs, click the Site dropdown to select the correct Company Site Location or Study Provider, next select the Documents for dropdown to select the correct user. Once this is done, the RealTime system will bring you to the correct user’s My Docs section. Users are also able to access user’s My Docs areas by visiting the Manage Entities tab > Company Site Location or Study Providers > Manage

Personnel and a list of all system users will be provided. Click the button under the Documents column. This action will take the user straight into the user’s My Docs section to view and manage records.


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STUDY ORGANIZATION

ORGANIZING CATEGORIES IN A STUDY

Categories can be added by an administrator to the eDOCS template and applied across studies within the eDOCS Admin tab or categories can be added to a specific study within the study-specific eDOCS tab. To add a

new category to the eDOCS section, utilize the button located at the top left of the screen.

DELETING CATEGORIES IN STUDY

Categories can be deleted for a specific study using the trashcan icon . If a category is deleted with this method, only that specific study will be affected. Please note that the trashcan icon will not be available if


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records are uploaded into the section you wish to delete. The record(s) will need to be archived and/or moved to another folder, and the screen refreshed before the trashcan icon appears.

ADD A FOLDER TO A CATEGORY IN A STUDY

To add a folder to a category, hover the mouse over the selected category name and select the icon. Folders can also be added to specific studies without affecting other studies in your system.

Activating version control allows the system to track all versions of each document uploaded to this folder. Users will be able to quickly identify current versions and older versions. Versioning also allows the system to track the sequence in which documents are uploaded.


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ORGANIZING FOLDERS IN STUDY

To organize categories and folders in a specific order, simply hover the mouse pointer over the selected category/folder name and option icons will appear. Click and hold the arrow icon . While continuing to hold the arrow icon, drag the section to its appropriate location. All other sections will shift position as appropriate.

Folders can also be organized for a specific study using the arrow icon . If a section is moved with this method, only that specific study will be affected.

Folders/categories can also be edited for a specific study using the edit icon . If a section is edited with this method, only that specific study will be affected.


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EDITING FOLDERS IN A STUDY

To edit a folder, simply hover the mouse pointer over the selected folder and option icons will appear. Click the

edit icon . If a folder is edited with this method, only that specific study will be affected.

Once the edit icon is clicked, a pop-up window will appear on the screen and allow the user to change the

name of the folder. After updating the name, click and the new name will populate in the category header. The user may also change the settings for versioning.


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DELETING FOLDERS

Folders can also be deleted for a specific study using the trashcan icon . If a folder is deleted with this method, only that specific study will be affected. Folders can only be deleted if there are no documents in the folder. Once the documents in the folder have been archived or moved, the user will see the delete option


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SUPPORTED FILES

RealTime-eDOCS™ supports and uploads several common files such as PDF, DOC/X, XLS/X and MSG (i.e., Word documents, Excel spreadsheets and Outlook emails). No matter what type of file the user chooses to upload into the system, a PDF/A file will be generated for view and storage within the system. PDF/A is an ISO-standardized version of the PDF specialized for digital preservation of electronic records.

If a DOC/X, XLS/X or MSG file is uploaded into the system, not only will a PDF/A version be generated but RealTime-eDOCS™ also preserves the original file in original format.


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ADDING NEW RECORDS

To add a new record to the system, click the button within the folder. To add a new version of an

existing record, use the button.

After clicking the button, a pop-up window will appear on the screen. Browse your computer files or simply drag and drop a file into the window to upload a document. Always click the

button to complete the upload.


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After clicking the button, a pop-up window will appear on the screen. Browse your computer

files or simply drag and drop a file into the window to upload a document. Always click the button to complete the upload.

Title entry box is freeform before adding a document to upload, however if a document is selected for uploading before entering a title- the file name of the document will pre-fill the title box

Version if versioning control is turned on within the folder you will see this box to allow to organization of multiple versions of a single document. You can either use a numerical or date format (ex: 2.0 or 09May2019)

Comments is also a freeform text box and allows for comments such as a Summary of Change on a particular document. These are comments that are visible to internal users in addition to monitors.

SETTING EXPIRATION DATES

When uploading documents, users have the option to add an expiration date. RealTime-eDOCS™ will notify the appropriate user via email thirty days prior to expiration and on the day of expiration as a reminder to update their records. The expiration date can also be set as a simple reminder for any record.


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Document expiration emails will be sent to the following individuals based on the section the record is uploaded to, the user’s privileges, and the studies that a user is assigned to.

ELECTRONIC SIGNATURES (ESIGNATURES)

RealTime-eDOCS™ makes it simple to request electronic signature (21 CFR Part 11 Compliant) from users. When uploading a document that requires signature, click the checkbox within the prompt to request signatures. Once this box is checked, a list of users for that study will appear. Check next to each applicable name before completing the document upload to have the system send the request for electronic signatures. If an individual has already signed a particular document, the date and time of signature will be indicated in the list of names.

After clicking the button, each required user will receive a notification within the RealTime-eDOCS™ system and a notification will be sent to the person’s email address.

SIGNATURE DUE DATES

Adding a signature due date to a signature request will prompt the user to sign the document by a given date. Users can view the signature due date within their signature request email and on their signature request page. If the user has not signed the document by the signature due date, daily email notifications will be sent to the signer until the signature is completed.


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PRESELECTING SIGNATURE STATEMENTS

When sending a signature request to other users, there will be an option to pre-select the signature statement that you want that individual to sign with.

If a signature statement is pre-selected by the signature requester, this statement will also show up pre-selected for the signature signer.


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If the user signing the record decides to change a pre-selected statement, a pop-up warning will display on the screen before the user is able to make the change.

SIGNING DOCUMENTS ELECTRONICALLY

To sign a document electronically within the RealTime-eDOCS™ system, click the notification icon in the

header or follow the link provided in the email notification. Next click the button to enter the Signature Requests section within you MyDOCS area that lists all documents signed and/or pending signature.

Some users may be required to review before signing.

On the Signature Request page, click the button to activate the Sign Document pop-up window.


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The Sign Document window will ask the user for a Statement (selected from a dropdown list), plus a username and password.

Once the user’s credentials are entered, RealTime-eDOCS™ will add the electronic signature to the document in the form of a digital stamp as seen below. This stamp is added to a signature page that is permanently attached to the record and cannot be removed/modified once it’s been established.

ADDING ADDITIONAL SIGNATURES AFTER THE INITIAL REQUEST

Users can request electronic signatures after the record has been uploaded. To request an electronic signature

after upload, simply click the edit document details icon to access the upload form for requesting signatures. The steps mentioned at the beginning of this section will be used to complete the signature request.


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CERTIFIED COPIES OF ORIGINAL DOCUMENTS

In the event that the user needs to upload a document with an original “wet ink” signature or writing (e.g., 1572, CV, Financial Disclosure, Source Documents, etc.), RealTime-eDOCS™ allows users to meet FDA expectations by certifying the scanned record as an exact copy of the original document. Before uploading the document to the system, first check that the scanned record is readable, and is an exact copy of the original. Next, check the box within the New Document prompt for Certified Copy. An electronic signature will be added to the document to show that the record has been certified by the user as an exact copy of an original document. When a user prints a certified copy from the system, the electronic stamp will be attached to the document to show the audit trail.

Documents saved as a Certified Copy will be indicated in the system with a green checkmark .


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SORTING RECORDS

To sort existing records within RealTime-eDOCS™, use the button in the top right corner of any page.


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SORTING RECORDS WITH THE DRAG AND DROP FEATURE

For version-controlled folders, sequence numbers for existing records can be changed using the drag and drop

feature. Simply hover the mouse over the column, then click and hold the mouse button. Move the mouse up and down to move the record to the appropriate location.


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DOCUMENT OPTIONS

Once a document is uploaded into the system, the user will have a variety of options to choose from:

1. The icon allows users to view the document in a new browser.

2. The icon allows users to View or edit document details .

3. The icon offers an extended list of options, which also includes the ability to:

a. Download the document from the system.

b. View the history (Audit Trail).

c. Add to Document Cart

d. Attach a signature page.

e. Read/Write notes. f. Message the Monitor/Reviewer.

g. Securely email the document.

h. View or share a document using a secure URL.

i. Move document.

j. Archive a document.


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AUDIT TRAIL

RealTime-eDOCS™ maintains a secure, computer generated, time-stamped audit trail of all user actions that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record.

Viewing the audit history of an electronic record is simple. To view the audit trail for a particular document,

simply click the audit trail icon for the document under review and the complete history will appear in a pop-up window. The audit history may be filtered by Action Type and/or User.


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DOCUMENT CART

The document cart can be sent for bulk signing by clicking on Options and then Bulk Sign and then send the cart to one or more system users to sign with one signature.

The bulk signing form has the options to pre-select the statement of testament, select the same statement for all documents, assign a signature due date and select user(s) to sign, then click Save and Send.


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In the MyDocs section, there is a document cart feature where users can group documents for downloading, sharing or sending for bulk signatures. Documents can be added to a new cart by searching through the three sections of eDOCS (Study Regulatory, MyDocs or General Site).

When creating a new cart, the user will select the target area, category, folder and specific document to be added. Once added, documents can be removed by selecting Remove Item. A Cart Title is required and Comments are optional and then the user can click to Save Cart.

ATTACH SIGNATURE


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ATTACH SIGNATURE SHEET

Attach signature sheet option is rarely used now, however was added in the beginning of eDOCS to allow for wet signature sheets to be added to documents that had already been uploaded into the system.


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READ/WRITE NOTES

This document option allows for an internal communication tool within a specific document. These comments added here cannot be viewed by the monitor.

MESSAGE MONITOR/ REVIEWER

See page 57 for information on managing monitor portals and responding to queries


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EMAIL DOCUMENT

Email document option allows for you to securely send an encrypted read-only view of the document. Our system will auto-populate a pre-filled email for you. This can be emailed to anyone outside of your network and the user receiving this email doesn’t have to have a RealTime User login to view.

VIEW/SHARE DOWNLOAD URL

View/Share Download URL document option allows for you to securely send an encrypted read-only view of the document with a pre-populated link to share either internally or externally.


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MOVE DOCUMENT

This option allows for a document to be moved to a different section within the system. This option will only be available for the 1st version, or document in sequence 1 and will move all additional versions of that document associated. Documents can be moved to Study Docs, User Docs, or Site Docs


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ARCHIVING DOCUMENTS

Electronic documents can be archived by using the archive document feature. This feature is useful if the user needs to remove a document that was uploaded on accident, or when a document is considered inactive and no longer in use. Please note that the system NEVER performs a hard-delete of records. Archived records can always be restored to their original location.

VIEWING ARCHIVED DOCUMENTS

All archived documents can be viewed using the Archived Documents section of the eDOCS Admin tab. This tab is accessed by users with eDOCS:Admin privileges


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RESTORING ARCHIVED DOCUMENTS WITHIN EDOCS ADMIN

Only users with eDOCS:Admin rights will be able to restore archived documents. The Restore Document icon

allows users to restore visibility of the document to other users. Restored documents will appear in their original file location.

DOCUMENT VISIBILITY SETTINGS IN MYDOCS AND GENERAL SITE DOCUMENTS

When uploading a new version of a document to the General Site Documents or My Docs sections, the user will notice options for Document Visibility. General Site Documents and the user’s My Docs area are considered “Origin Locations” meaning documents can be filed accordingly with document visibility. Document Visibility can be set to General, Sponsor-Specific or Study-Specific. The General setting allows the document to be viewed by all users. The Sponsor-Specific setting will only allow users assigned to a specific sponsor to view the record. The Study-Specific setting will only allow users assigned to a specific study to view the record. This feature is particularly helpful when controlling what is relevant for the monitor can view within the monitor portal.

When choosing the Sponsor-Specific setting, a drop down menu will appear, allowing the user to pick the sponsor that will be assigned to this particular record. Multiple sponsors can be chosen, if needed.


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When choosing the Study-Specific setting, a drop down menu will appear, allowing the user to pick the study that will be assigned to this particular record. The studies listed are those they were delegated to under “Manage Studies”. Multiple studies may be chosen, if needed.


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For Multi-Site Customers Only (General Site Documents)

In addition to setting document visibility settings, users within a multi-site system also have the ability to set Site Visibility settings. Documents within this section can be assigned to one or more available sites. For each site selected, assigned documents will appear in the electronic regulatory binder(s) for that site.


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ICF TRACKING

The CTMS will track each version of the informed consent plus the study participants that sign each version. This feature can easily replace paper methods of tracking informed consent documents for your studies.

To activate the ICF Tracking feature, first navigate to the Study Regulatory Documents – Template section located under the eDOCS Admin tab. Locate the folder for Informed Consent Forms and click the edit folder

option . Next, check the ICF Tracking box in the Edit Folder window.


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UPLOADING INFORMED CONSENTS

Once ICF Tracking is activated, users will be able to upload ICFs to the Study Regulatory Documents section of a specific study.

First click the button and a pop-up window will appear. To implement the tracking feature, the most important information to enter during upload is the Effective Date & Time and Study Arm. The Effective Date & Time will dictate which subjects will be required to sign an ICF at their next scheduled visit. For this reason, it’s important that sites have a process for knowing when their new ICFs are effective. For example, are new ICFs at your site considered effective once you receive the approved version from the IRB, or does your site have an internal “processing/routing” policy before making a new ICF effective? Each site may have a unique process to fit their needs.

Complete the rest of the information within the pop-up window as required to upload your ICF. For more details on uploading documents, please see the section titled, Adding New Records.


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SUBMITTING SIGNED INFORMED CONSENTS

Once a new version of an ICF has been uploaded to the system, and an effective date & time has been entered, the current version of that ICF will automatically link to the Visit Tracking page in RealTime-CTMS™. The clinical research coordinator (CRC) can quickly find out if a subject is required to sign a new consent at their next visit by navigating to the study Visit Tracking page of their study and clicking on the visit that needs to be completed.

Once a visit date is clicked, the CRC will be taken to the subject’s On Study tab. If the subject is required to sign an ICF, the system will provide a red notification indicating the number of ICFs available for signature. Below the notification, the name of each ICF will be provided to help the CRC quickly determine what needs to be signed by the subject. Clicking on the file name link will allow the CRC to view the document and print as needed for their visit.

After the subject has signed the paper ICF, the CRC will click the button next to the file name and a pop-up window will appear.

Click link to view/print document.


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The CRC will complete the information in this window to document that the ICF was signed, the user that completed the ICF with the subject, and the date and time of consent. A scan of the signed ICF can be uploaded for digital storage.

Always click to complete the transaction. After saving, an ICF Tracking log will generate automatically within your eDOCS folder to track all subjects that sign, or don’t sign, each version of the ICF.

Please note that if the user enters a date or time that is prior to the ICF effective date & time set when uploading the ICF to eDOCS, the system will automatically issue an error message to prevent illogical dates/times from being entered.

A similar message will appear if the date/time entered is in the future. Both of these messages will prevent the user from saving information until a logical data/time is established.


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In the event that a subject was not required to sign a particular ICF, the CRC can click the check box indicating that the ICF was not required and the ICF will be skipped. Please note that it is very important that the CRC/investigator understand their Sponsor/IRB requirements for each version of the ICF to ensure that subjects sign all applicable ICFs during the study. If the ICF is skipped, a pop-up window will appear and allow the user to include any necessary notes.


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INFORMED CONSENT TRACKING LOG

After a user has submitted an ICF in the system, an ICF Tracking log will populate automatically. To view the log, simply visit the eDOCS tab for that particular study and expand the table located under each specific ICF.

Based on the information that the CRC enters into the system, RealTime-eDOCS™ will track all ICFs that are Signed, Unsigned and Skipped for each version of the ICF.

Expand the ICF Tracking log by clicking the +.


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VIEWING SIGNED INFORMED CONSENTS

There are two methods to view a signed ICF that has been scanned into the system. The first method requires the user to navigate to the subject’s On Study tab by clicking on the completed visit of choice.

After clicking the appropriate visit, the user will be taken to the subject’s On Study tab. Simply click the

button to view all ICFs that have been signed for that subject.

After clicking the button, a pop-up window will appear that lists all ICFs completed for that specific subject. If a scanned copy was uploaded into the system, a list of options is available

by clicking . Options are to view the document , download the document , view/edit document

details or archive the document . If a document was skipped, enabled by checking the box “ICF

Click on a completed visit.


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signature not required”, it is not listed with the scanned documents. Click the button to view the reason for skipping signature.

Another way to view the ICFs signed by a particular subject would be to enter the eDOCS section for a particular study and expand the ICF Tracking log. If a scanned copy of an ICF was uploaded to the system, an icon will appear to view or download the document. Options to view the audit history and read/write notes will also be available.


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GENERATING A PDF OR EXCEL VERSION OF THE ICF TRACKING LOG

To generate a PDF or Excel version of the ICF tracking log for a particular version of the ICF, simply click the

options button for that ICF and locate the option to or

.

The PDF or Excel can be viewed, download and shared as needed. Also, the monitor will be able to generate the same PDF or Excel within their monitor portal.


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SUBJECT DOCUMENTS

Within the Subject Documents tab of each subject profile, users can upload documents specific to that subject. The General Subject Documents section is great for uploading medical records, non-study prescreen consent forms, or any other general level document. Additional folders can be added to this section as needed.

The Subject Study Documents section works well for uploading study-specific records (e.g., a scanned copy of Source Documents, Written Doctor Notes, etc.). This section is generated once a subject enrolls into a study.


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MANAGING MONITOR PORTALS

The monitor portal allows sponsor CRAs/monitors to access their assigned study records. A monitor portal unique to each user can also be assigned to Sponsor/IRB auditors and FDA inspectors as needed. The monitor portal only reveals records specific to the user’s study assignment (managed by the site) and records cannot be altered through this portal.

Setting up a monitor portal is simple but is also privilege based. After identifying the assigned study, locate the Study Contacts section at the bottom of the General Info tab.


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Ensure that the contact is added to the study contacts list and click the button under the Options column for that individual. The webpage will expand and allow you to assign a username and temporary password for the contact.

The study contact must have a valid email address since the person will receive their temporary password and portal access link via email. A username must be set up by the site user. It is suggested to use the person’s first initial combined with their last name. For example, if the person’s name is John Smith, then his username will be jsmith. Another simple option would be to use the person’s email as their username.

Next, select the user’s Access Type from the dropdown menu.

Lastly, assign the appropriate study access using the list of Available Studies.

Before sending a temporary password to the study contact, you must save this contact’s information with their newly assigned username.


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Once the username is saved within the system, a new link will appear within the Password section to Set & Send Temporary Password to User. Once this link is clicked, the study contact will be assigned a monitor portal for viewing study records and will receive an email with their portal web address and temporary password. Due to security reasons, the site user will need to inform the study contact of their username. The username will not show up in the same email as the temporary password.

WHAT IF A MONITOR LOSES HIS/HER LOG-IN INFORMATION?

If the study contact has already been issued a monitor portal, you will see that it is Currently Set under the Password section. If the study contact has lost his/her username and password, a site user can inform the monitor of their assigned username and use the Set & Send Temporary Password to User to send a new temporary password to their email.


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MONITOR QUERIES

Users can issue comments and queries through the monitor portal. Queries can be reviewed by site staff by visiting their My Docs section under the Open Doc Queries tab. If a user at the site has outstanding monitor

queries that need to be addressed, a notification will appear in the RealTime-eDOCS™ header .


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VIEWING A QUERY

To view a query/conversation, simply click the icon. This will activate a pop-up window that catalogues all discussions about a particular query between the monitor and the site user.


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RESPONDING TO A QUERY

To respond to a monitor’s comment, simply type your message in the message box at the bottom of the pop-

up window and click button. This button only posts the message to the discussion board and does not indicate to the monitor that the query has been addressed.


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MARKING A QUERY AS “ADDRESSED”

To mark the monitor’s query as Addressed, simply click the button next to the monitor’s comment.

Once the button is clicked, the monitor will be notified through the monitor portal that the site has addressed the query. Please note that this button does not close out the query. Only the monitor will have the ability to close out a query/discussion after verifying that appropriate actions have taken place.

For more details about the query system, specifically from the monitor’s point of view, please reference the Monitor Portal User Manual provided by Real Time Software Solutions, LLC.


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GENERATING FRONTEND REPORTS

To access frontend reports, click the “Reports” link on the left of your screen. Frontend reports are visible to users with the Documents: Admin privilege.

TYPES OF FRONTEND REPORTS

General Site Documents Report – This report allows users to see all current/old records within the General Site Documents section of the system. This report is great for locating expired documents or even documents that are expiring in the near future. Note: Date Range is required on this report

Study Document Report – This report allows users to see all current/old records within the Study Regulatory Documents section of each study. This report is great for locating expired documents or even documents that are expiring in the near future. Note: Date Range is required on this report

User Document Report – This report allows users to see all current/old records within the My Docs section of the system. This report is great for locating expired documents or even documents that are expiring in the near future. Note: Date Range is required on this report

Monitor Query Report – This report allows users to view all monitor queries (addressed, unaddressed, and resolved statuses) for one or more studies in the system.

Signature Status Report – This report allows users to the status of signature requests throughout the system on a user basis and/or study basis.


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EDOCS ADMIN USER MANUAL

SETTING UP TEMPLATES IN EDOCS ADMIN

Within the Administration section you’ll find the eDOCS Admin tab. You’ll see 4 sections within the tab- Archived documents and three master templates for the General Site Documents, Study Regulatory Documents and Personnel/Delegate Documents. All 3 templates can be customized with different organizations of categories and folders. Once the template is established for each of these sections, this folder set up will automatically generate under the eDOCS tab for each study added to the system thereafter.

If a user decides to change the template settings, the user may decide if the changes will be applied to all current and future studies, or future studies only.

Users with the Documents: Admin privilege can also customize the folder set up within each study individually. This feature allows sites to add study-specific folders to accommodate special records and/or special sponsor requests.

Note: RealTime-eDOCS™ product is provided with a pre-loaded template for sites to get started immediately. This default template is designed to completely replace paper-based regulatory binders but can be standardized prior to beginning your studies.

Note: It’s important that the site develop an effective standard template that is easy for the site staff and monitor to manage/locate records.

The next few sections will provide an overview of each template section within eDOCS Admin.


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GENERAL SITE DOCUMENTS TEMPLATE

The General Site Documents section is great for storing records that are applicable for all studies (e.g., site-level documents). While each site is different, the following are items that may be considered for upload into the General Site Documents section: Equipment Calibration Records, CLIA Certificates (Lab), SOPs and Temperature Logs. When uploading records to this section, the user can control the Document Visibility using the following settings: General, Study-Specific or Sponsor-Specific. Document visibility definitions can also be reviewed on page 45 in this manual.

Document Visibility

General- This document would be filed into each study

Sponsor Specific- Would be filed into only selected sponsor specific studies (ex. Pfizer Temperature Log)

Study Specific- Would be filed into only selected studies


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STUDY REGULATORY DOCUMENTS - TEMPLATE

The Study Regulatory Documents – Template section allows sites to customize the folders and categories on each new study to upload and manage their study-specific regulatory records. This section will replace the majority of your paper-based regulatory binders.

PERSONNEL AND DELEGATES – TEMPLATE

The Personnel and Delegates section on each study will allow users to view training and qualification records for each staff member assigned to that particular study. This template will control the categories and folders within each user’s My Docs section, which ultimately get auto-filed into the Personnel and Delegates section of each study that a user is assigned to.


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ORGANIZING CATEGORIES IN EDOCS ADMIN

To organize categories in a specific order, simply hover the mouse pointer over the selected category name and

option icons will appear. Click and hold the arrow icon . While continuing to hold the arrow icon, drag the category section to its appropriate location. All other category sections will shift position as appropriate.


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The folders in the eDOCS template section can be customized and named any way that the site wants. Please Note: The Contracts and Budgets section is hard-coded into the system because only users with the Documents: View Contracts and Budgets privilege will be able to view and upload documents to this section during a study. Monitors will not have access to view contracts and budgets. Because of this feature, it is suggested to not change the name of this folder.

Categories can also be organized for a specific study using the arrow icon . If a category is moved with this method, only that specific study will be affected.

EDITING CATEGORIES IN EDOCS ADMIN

To edit a category, simply hover the mouse pointer over the selected category name and option icons will

appear. Then click the edit icon .


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Once the edit icon is clicked, a pop-up window will appear on the screen and allow the user to change the

name of the category. After updating the name, click and the new name will populate in the category header.

DELETING CATEGORIES IN EDOCS ADMIN

To delete a category, simply hover the mouse pointer over the selected category name and option icons will

appear. Then click the trashcan icon

Once the trashcan icon is clicked, a pop-up window will appear asking if the user is sure they want to delete the category. Once deleted from the template section, this section will not appear in the eDOCS section for future studies.


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ADD A FOLDER TO A CATEGORY IN EDOCS ADMIN

To add a folder to a category, hover the mouse over the selected category name and select the icon.

A pop-up window will appear on the screen to enter the folder name. If you want the new folder to appear on all existing studies and future studies, click the checkbox for Copy this category to existing studies with eDOCS enabled. If this new folder only needs to be applied to futures studies, do not click this checkbox. Under the SETTINGS section, users can apply versioning control and/or ICF Tracking.

Activating version control allows the system to track all versions of each document uploaded to this folder. Users will be able to quickly identify current versions and older versions. Versioning also allows the system to track the sequence in which documents are uploaded.


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DELETING FOLDERS IN EDOCS ADMIN

To delete a folder, simply hover the mouse pointer over the selected folder and option icons will appear. Then

click the trashcan icon .

Once the trashcan icon is clicked, a pop-up window will appear asking if the user is sure they want to delete the folder. Once deleted from the template section, this section will not appear in the eDOCS section for future studies.


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SYNCING A TEMPLATE IN EDOCS ADMIN

NOTE: Please note that study-level folders with records uploaded will not be affected but may cause duplicate folders or categories.

Within the Study Regulatory Documents – Template section, users can make modifications to individual categories and folders within the template or push an entire template out at once. Please see the section on ‘Study Organization’ in regards to adding and editing categories and folders within an individual study. If a site

wants to update all studies (with eDOCS activated) by pushing the entire updated template, the can be used.

Once the sync button is clicked, the system will first ask if the user is certain that they want to proceed with the action. Once activated, this feature will match all eDOCS studies to the template. Study-level folders and categories will be renamed appropriately for each study. Unnecessary folders/categories will be deleted (if already empty), and new folders/categories will be added if they do not currently exist. The records can be manually moved into the appropriate folders or archived as needed. Once the folder is empty, then the user will be able to delete or sync as needed.


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GENERATING ADMIN REPORTS

To access admin reports, you must have system administrative privileges. Click the “Administration” link at the top of your screen and visit the Admin Reports tab. Reports can be displayed in the web browser or exported into Excel.

TYPES OF ADMIN REPORTS

Active Studies Progress Report – This report extracts milestone dates (if they have been entered) from the study progress tab of each study. This allows users to track study metrics, such as the amount of days that it takes for a study to have its SIV after it has been awarded to the site, and many other metrics.

Audit User Access Report – This report allows users to view the system access history for one or more system users, including dates and times for login, logout, failed login attempts, and much more. This is a great report to determine if any suspicious login sessions have occurred.


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CUSTOMIZING SIGNATURE STATEMENTS

eDOCS Admins have the ability to standardize all signature statements. Within the Manage Tables tab of the Administration section, select the table titled, Signature Statements (eDOCS).

Signature statements can be add/edited to fit the site’s needs. You may also select a default statement which indicates the statement that will show up as the first option when signing a record. Once a statement has been entered, be sure to click ‘Add Entry’ or ‘Update’ depending on if a statement is being added for the first time or updating a current statement.

Furthermore, an additional date field with an optional title can be activated for any statement. This date field is great for documenting training dates or any other date the site finds useful. Once a date is entered, it will display with the person’s electronic signature.


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MANAGING ARCHIVED DOCUMENTS

All archived documents can be viewed using the Archived Documents section of the eDOCS Admin tab. This tab is accessed by users with administrative privileges.

RESTORING ARCHIVED DOCUMENTS

Only users with administrator rights will be able to restore archived documents. The Restore Document icon

allows users to restore visibility of the document to other users. Restored documents will appear in their original file location.