electronic protocol inquiry platform

PPD ePIP Research Assistant (RA2) User Manual

Version: 4.0 of 20 Effective Date: 01NOV2020 PPD Proprietary and Confidential

Electronic Protocol Inquiry Platform

(ePIP)

Research Assistant (RA2) User Manual



Table of Contents

Research Assistant Dashboard ................................................................. 3

Submit new inquiry .................................................................................. 4

Submit completed inquiry (tracking only) ................................................ 8

Check Status .......................................................................................... 11

Cancel Inquiry ........................................................................................ 13

Reporting ............................................................................................... 14

View Details of Inquiry ........................................................................... 15

Export PDF Copy of Inquiry .................................................................... 15

Update Attachments ............................................................................... 16

View Details of Inquiry - Audit Trail Information ................................... 16

User Manuals .......................................................................................... 18

Training Materials .................................................................................. 19

Session Time out .................................................................................... 20



Research Assistant Dashboard

The ePIP platform will display the Research Assistant dashboard after the user’s login credentials pass

authentication and authorization.

Research Assistant Dashboard

From the Research Assistant Dashboard page, the user can operate the following items.

Submit new inquiry On Behalf Of (OBO) Site User (SU)

Submit new completed inquiry (tracking only)

Access the Reporting tool

Check Status of Previous Submissions

Access the Frequently Asked Questions (FAQ) & Training Materials under Resources

Provide feedback



Submit new inquiry

Research Assistant users have the

ability to submit a new inquiry on behalf

of a Site User by clicking the Submit

New Protocol Inquiry icon or by

clicking the Submit New Inquiry

sub-menu.

After clicking a selection, the Submit

New Inquiry Step 1 Pick Protocol

page will appear. There are 5

parameters which must be set prior to

proceeding to the Step 2 “Fill Out Form”

page:

1. Sponsor Selection; the Sponsor List

includes all sponsors which the user

has been granted access to.

2. Protocol Selection; the Protocol List

only includes protocols associated

with the previously selected sponsor.

The list automatically refreshes based

on sponsor selection.

3. Site Selection; the Site List displays

sites associated with the specified

sponsor and protocol.

4. Site User Selection; choose a site

user from the dropdown list of users.

The list only displays users associated

with the previously selected site.

Manually enter a Site User if the

desired site user does not appear in

the Site User dropdown list and ask

the Project Manager to request a user

account.

If the “PPD Team” site is selected,

then the Site User Selection

disappears and a red tooltip appears.

Select a submission type. If a user

wants to submit a new inquiry, select

the New Inquiry option.

Submit New Inquiry Icon Submit New Inquiry

Menu

Submit New Inquiry Step 1

Select a Sponsor from the dropdown list

Select a Protocol from the dropdown list

Select a Site User from the dropdown list

If the Site User is not in the Site User dropdown list, then the Site User can be manually entered. **

Select a Site or PPD Team from the dropdown list.

Select a Submission type from the dropdown list

Select PPD Team only for internal team general questions.

Choose “New Inquiry” to receive a response. Select “Completed Inquiry” to track and document a previous response.



**By clicking the Manually Enter Site

User link, the user is required to enter

the Site User’s full name and email

address.

Note: Manually created users will not

receive emails from ePIP and cannot

access ePIP until an account has been

created through the proper channels.

This step simply associates the inquiry

with a specific person at the site and

provides contact information for the PM

and MM.

Click Create to complete the action.

Upon clicking the create button a

warning message pops up notifying the

user.

Click OK to acknowledge and continue.

Enter Site User



After selecting: Sponsor, Protocol, Site,

Site User and submission type

parameters in Step 1, users must click

the Next button to display the Submit

New Inquiry Step 2 Fill out Form.

Required fields are indicated with a red

asterisk. Some fields are auto-prefilled

by the system.

Users must choose the subject status.

Users must enter a subject ID or enter

NAV if the information is not available.

The Inquiry Description field is

required. It has a 1,000 character

limit, and a spell check function.

Prior to uploading an attachment,

users must indicate that the

attachment does not contain

prohibited subject identifiers. Users

may browse for and attach one or

more electronic file(s). The system

supports various file types up to

30MB.

Users may upload additional file(s) by

clicking the + Another button.

Urgency: Users are required to select

the urgency of their inquiry. The

system default is “Not Urgent”. PPD

intends to handle all inquires within

one business day of receipt. If an

Urgent option is selected, users will

receive a pop-up message with

instructions. Click the X to close the

pop-up notification.

The Non-digital checkbox should be

selected if additional information will be

sent to PPD that is not attached to the

inquiry in ePIP. A message will appear

with instructions when the checkbox is

ticked. Reselect button allows the user

to go back to Step 1.


Fill Out Form

These fields are auto populated by the system. Auto filled from

user selection in step 1.

Screened Randomized Other (Manual) Limit of 1,000 characters. Spell

check feature available.

Attach files up to 30MB in size. Multiple files may be attached.

If this checkbox is selected, a message appears with fax instructions.

Message pop up when “Urgent - Subject waiting at site” or “Urgent - other” selected.



After clicking the Review button in Step

2, the Submit New Inquiry Step 3

page will appear. This step provides the

user a chance to review their submission

for completeness and accuracy. Users

should also review the uploaded files.

The uploaded file(s) can be viewed by

clicking the file name

The Edit button allows the user to

return to Step 2 for editing

Once the record is confirmed accurate

the user may select the Submit

button.

By clicking the Submit button in Step 3,

the Submit New Inquiry Completed

page appears indicating a successful

submission.

A link is available for the user to

download a copy of the newly created

inquiry

The Submit Another button will

navigate the user to the Submit New

Inquiry Step 1 page

The Back to Home button will

navigate the user to the Welcome to

the New Protocol Inquiry

Platform home page.


Review & Submit

Submit New Inquiry Completed Page



Submit completed inquiry (tracking only) After clicking, Submit New Inquiry,

the Step 1 page will appear.

Choose the Sponsor, protocol, site and

site user then select Completed

Inquiry (tracking only) to track an

inquiry processed outside of ePIP.

(Please refer to Submit new Inquiry

Step1 for more details.)

After clicking the Next button in Step 1,

the Submit New Inquiry Step 2 page

will appear.

Required fields are indicated with a

red asterisk.

Users must enter a summary of the

inquiry description and a summary of

the PM, MM, and/or Sponsor

response.

Users must select the Inquiry Type

from the drop down menu

Inclusion/Exclusion

Protocol Clarification

Targeted Eligibility

Protocol Deviations

-Informed Consent

-Inclusion Criteria

-Exclusion Criteria

-Study Treatment Randomization

-Study Treatment Admin/Dispense

-Study Treatment Compliance

-Study Treatment Unblinding

-Missing Endpoint Assessments

-Missing Non-Endpoint Assessments

-Study Procedures/Assessments

-Concomitant Medication

-Visit Scheduling

-Withdrawal/Term Criteria

-Other Protocol Deviation

Submit completed (tracking only) Inquiry Step1

Submit completed Inquiry Step2

Select “Completed Inquiry” from Submission type dropdown list

Summarize the response here. Limit of 1,000 characters. Spell check feature available.

Inclusion/Exclusion Protocol Clarification Targeted Eligibility Protocol Deviations ICH/GCP Deviations Other (Manual)

Urgent option defaults to “Not urgent”, and can't be changed

Summarize the question here. Limit of 1,000 characters. Spell check feature available.



ICH/GCP Deviations

-Inv Qualifications/Agreements

-Data Privacy

-ICF Process/Timing

-Inv Randomization/Unblinding

-Inv Subject Medical Care

-Study Trtmt Supplies/Control

-Inv Adequate Resources

-Inv Oversight

-Inv Record Keeping CRF

-Esntl Docs

-Inv Record Keeping Source Docs

-Inv Safety Reporting (CRF)

-Inv Safety Rptg (Reg/Sponsor)

-Inv Communication with Ethics

-Local Regulatory Compliance

-Other GCP Deviation

Progressive Disease Form

Treatment Termination Form

Eligibility Form

Treatment Beyond Progression

Other (Manual)

Check with the Medical Monitor or

Project Manager if you are unsure.

Users must select a Request

Decision from the drop down. Drop

down choices are:

Approved

Denied

Not Applicable

Check with the Medical Monitor or

Project Manager if you are unsure

Prior to uploading an attachment,

users must indicate that the attachment

does not contain prohibited subject

identifiers. Click the Browse button to

upload supporting documentation.

Urgent option defaults to Not

Urgent. This cannot be modified.

Please refer to Submit New Inquiry

Step 2 for more details.

Submit completed Inquiry Step2 continued

Supporting documentation required. Acceptable file types listed up to 15MB in size. .

Approved Denied Not Applicable

Inclusion/Exclusion Protocol Clarification Targeted Eligibility Protocol Deviations ICH/GCP Deviations Other (Manual)



After clicking the Review button in Step

2, the Submit New Inquiry Step 3

page will appear. This step provides the

user a chance to review their submission

for completeness and accuracy. The

uploaded file(s) can be viewed by

clicking the file name

The Edit button allows the user to

return to Step 2 for editing

By clicking the Submit button in Step 3,

the Submit New Inquiry Completed

page appears indicating a successful

submission.

A link is available for the user to

download a copy of the newly tracked

inquiry

The Submit Another button will

navigate the user to the Submit New

Inquiry Step 1 page

The Back to Home button will

navigate the user to the Welcome to

the New Protocol Inquiry

Platform home page.

Submit Completed Inquiry Step3

Submit Completed Inquiry Completed Page



Check Status

Users can choose Check Status

sub-menu from the Protocol Inquiry

drop down list.

The Inquiries Submission Status

page will appear. From this page, users

may view all user related pending

inquiries. (Note: answered/completed

inquiries do not display on this page but

may be located on the reporting page.)

Users may search for inquiries by

choosing Sponsor, Protocol, Country,

Site, Date range fields or search by

ePIF #.

The default listing displays Urgent

inquiries at the top and subsequently

by time the inquiry has aged from

initial submission.

Users can sort by clicking each column

header except the Actions column.

The default number of inquiries

displayed per page is 25. Users can

change the number to display 10, 25,

50 or 75 records.

Urgent inquiries are highlighted with

an ‘!’ symbol

The OBO column helps users identify

which inquiries were created on behalf

of the site by PPD. PPD OBO inquiries

are identified with the “Y” icon.

Check Status Menu

Inquiries Submission Status Page

All inquiries with the status of “pending” may be viewed from this screen. Enter search criteria to filter for specific pending inquiries.

The Icons indicate where the inquiry is in the workflow New = pending Project Manager / Clinical Trial Manager SU = pending Site User follow up PM = pending PM follow up MM = pending Medical Monitor input SP = pending Sponsor input



Users may view the inquiry details by

double clicking the inquiry row or

clicking the View link. The system will

display the View Details of Inquiry

page.

The display includes all inquiry details

to date.

The page also displays any

subsequent follow up requests and

comments beneath the original

submission.

Each subsequent comment includes

the respondent’s role, name, and date

and time of the comment.

The Reselect button allows the user

to return to the Check Inquiry

Status page to make another

selection.

View ePIF Details Page

(Example including respondent comments)

View respondent’s comments back and forth



Cancel Inquiry

RA2 users may cancel a previously

submitted inquiry by accessing it from

the Check Status - View Details of

Inquiry screen. Inquiries may be

cancelled from the View Details of

Inquiry page by clicking the Cancel

button. Note that any attachments

connected to the inquiry will be deleted

when canceled.

Inquiry Lock

Inquiries can only be responded too by

one user at a time. If a user has an

inquiry open, that inquiry will only be

available in Read Only status for

additional users.

If an inquiry is locked, the image will display on the top of the inquiry page and on the reporting page along with details of the user who currently has it locked. An inquiry will be unlocked if a user’s session times out. An inquiry can also be unlocked by a PM, MM or RA2 user via the Reporting Page or by contacting ePIP Support.

View ePIF Details Page (New ePIF with

cancellation option)

The “Cancel” button is available to PM, MM and RA2 users. Any attachments associated with a canceled inquiry will be deleted.



Reporting Users can click the View All Inquiries

(Reporting) icon or select the

Reporting menu to view the

Reporting page.

From the Reporting Query page, users

can view all user related inquiries

including any closed/completed

inquiries:

Users can search for inquiries by

choosing from the drop-down lists by

sponsor, protocol, country, site, etc.

The default listing of inquiries is by

submission time with the oldest

inquiry displayed on the top.

Users can sort by clicking each column

header except the Actions column.

The default number of inquiries

displayed per page is 25. Users can

change the number to display 10, 25,

50 or 75.

Users can export all records returned

for the query (all pages) by clicking

the Export menu and selecting either

PDF for copies of each individual

record or Excel to export a listing

report of all records.

Users can export single or specific

multiple Inquiries into PDF format or

Excel format by selecting the check

box in front of each record.

Users can select all records displayed

on the page by ticking the check box

at the top.

The Reporting Status page also

includes a link to view the Audit Trail

for each inquiry.

Reporting Icon

Reporting Menu

Reporting Page

Select “All” by clicking this box.

Select multiple or individual records by clicking individual boxes.

Click Audit link to view audit history.

Enter search/filter criteria: Sponsor, Protocol, Country, Site, etc.

Click “Export" then "PDF” to export copies of each record or Click “Export Excel” to export a listing report of selected inquiries.

Choose the number of records displayed per page by selecting: 10, 25, 50 or 75



View Details of Inquiry Users may view an inquiry by double

clicking the inquiry row or clicking the

View link. The system will then display

the View Details of Inquiry page.

The display includes all inquiry details

to date.

The page also displays any

subsequent follow up requests and

comments beneath the original

submission data.

If the inquiry status is “Complete”,

below the inquiry submission

information, details of the final

resolution are displayed.

If the inquiry status is cancelled, the

user name and the date and time of

the cancellation are displayed.

Export PDF Copy of Inquiry Users may click export to export a PDF

copy of the record. If the record

contains attachment the file will be

exported as a zip file including a PDF

copy of the record and copies of the

attachments.

Inquiries with attachments will be

exported in a zip file including the PDF

copy of the inquiry details and

attachments in their original format.

View Completed Inquiry Details

Resolution details are displayed

Click Export to export a PDF copy of the record and any attachments.

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Update Attachments If the inquiry has single or multiple

attachment(s), an RA2 user may

update the attachment by first

downloading a copy, making the

necessary changes, and saving the

new version to their computer.

When you are ready to replace the

original click the Update

Attachment button.

The ePIF Attachments window will

display

Click Browse to locate the corrected

document

Enter a Reason for the update.

(Example: Redaction of patient

privacy information.)

Click the “Save” link to complete the

action.

Click the red X to cancel the action

and return to the “View Details of

Inquiry Page.

View Details of Completed Inquiry – Update Attachment

To redact patient privacy information on an attachment; download a copy, make the changes, and then click “Update Attachment” to browse and upload the corrected document.

Users are required to enter a reason for the update.

Browse your computer to locate the updated version of the document.



View Details of Inquiry - Audit Trail Information

By clicking the Audit link, the system

will display the View Details of

Inquiry Audit Trail page.

The details include the original inquiry

submission and ePIF Audit Trail

Information.

If the inquiry status is “Complete”,

details of the final resolution are

displayed below the inquiry

submission information. If the inquiry

status is cancelled, the user name

and the date and time of the

cancellation is displayed

The Back button returns the user to

the Reporting page.

Users may click the Export PDF

button to export the inquiry Audit Trail

information as a PDF file.

View ePIF Audit Trail Page

Cancellation details are displayed.

Export a copy of the audit trail to PDF.

Click the Back button to return to the reporting page.

User interactions are captured in the audit trail



User Manuals

Users can click the Resources tab

and choose FAQ from the menu or click

the Help link in the footer to enter into

the FAQ page. In the FAQ page, users

can view the user manuals.

FAQ Menu Help Link



Training Materials

Users are required to review and

acknowledge any new training material

before proceeding in the system. The

Welcome to the Training Page

displays upon successful log in and lists

all required training material. Users

may then click the Training Material Link.

A new window opens displaying the

training content. Users must click the

box acknowledging they understand the

document and/or have completed the

training item. Finally users click the

“Proceed to home Page” after all

required training is completed.

Users may click the Resources

tab and then select Training Materials

from the menu to access the Training

Materials review page.

The Welcome to the Training

Page displays all training items available to the user based on their user role.

ePIP Training Materials Page

Training Materials Menu

ePIP Training Materials Review Page

Click the link to display the training

Tick the box to certify completion.

Proceed to home page after all required training is confirmed.



Session Time out If the user remains inactive in the system, the user session will time out. Users may click the login link to return to the login page to sign in again.

When there is less than 5 minutes left before the session times out the system will provide a pop-up warning to notify the user. Click the Cancel

Session Time Out button to reset the timeout.

Session time out notification (session lost)

Session time out notification (warning)

electronic protocol inquiry platform

Documents