1. Training for Research Agencies
Customer Engagement Programs (CEP) and the Line of Sight (LOS) System version 2.0
Training for Research Agencies
Business Analytics & Insights

2. We are recording this session, so please keep your phones on mute.
Housekeeping notes
We are recording this session, so please keep your phones on mute.
If you have questions, please use the chat function in WebEx and send your questions to Lisa Coldiron.
We will take breaks during the training to answer your questions
And, there will be a Q&A session at the end.
This deck will be forwarded to all participants following the workshop.

3. What you will learn from this training module
What is the LOS system?
Step by step process explaining your interaction with LOS
Gaining Access to LOS
Assigning personnel to a research project
Creating and submitting activity logs
The importance of the LOS summary page
Troubleshooting / Q&A

4. What is the LOS system?

5. LOS…
Was designed to enable BAI oversight of all primary market research programs to ensure compliance with Pfizer corporate policy.
Is a user-friendly platform that replaces all of the paper-based compliance processes currently in use:
Excel spreadsheets of daily activities
Certification of program start and end dates
Certification of AE training
Is a validated system, which means it can be utilized during an audit or inspection
Is ‘read only’ for Pfizer colleagues – research vendors are the only persons who can actually input information into LOS.

6. LOS is a platform that is connected to 2 other systems – CEP Inventory and PPLS
Project Owner
Project Name
Project Description
BU / Stakeholder
Country of Conduct
Planned Start Date
Actual Start Date
Planned End Date
Actual End Date
Vendor Contact Info
And others….
CEP Inventory contains a historical record of all customer engagement programs. BAI is responsible for inputting projects into the inventory
PPLS is the “external” version of P2L – an online training system
List of certified vendor personnel
LOS is updated by CEP and PPLS every 24 hours (at a minimum)

7. Vendor personnel working on a Pfizer CEP can fall into one of two categories
Vendor Project Manager
This is usually the project leader for the research
This person’s name/ is entered into the CEP inventory by the Pfizer program owner
You can have more than one vendor project manager, especially for multi-country studies – just be sure to include all names and s in your proposal, so the Pfizer program owner can record them in the CEP system.
Decides who within their firm or subcontractors will support the research project
And be required to complete the two courses (Your Reporting Responsibilities and Supplemental CEP Training) that comprise CEP Certification courses. All personnel who work on Pfizer projects must have completed the CEP Certification courses.
Sends LOS invitations to any personnel or subcontractors who do not have a current LOS account or CEP Certification
All invitees must have a valid, professional address – do not use a personal address
Each person must have a unique address – do not use distribution lists or mail boxes
Assigns fully certified personnel to the research project in LOS (including themselves)
Vendor Project Personnel
Anyone working on a specific project and assigned to that project in LOS

8. The CEP Inventory provides LOS access to the Vendor Project Manager
Under the ‘Vendors’ tab in the CEP Inventory:
BAI will upload the vendor contract
Contract is visible to only BAI program owner and safety
BAI will indicate that this project is managed through LOS
BAI will enter the name(s) of the vendor project manager (VPM) and his/her address
Vendor will receive invitation from LOS (if BAI has checked that the program is managed in LOS)
Once the VPM accesses LOS, he/she can add additional employees to the research project.

9. Using LOS
The balance of this presentation will focus on how to incorporate LOS into the conduct of primary market research.
Gaining Access to LOS
Inviting personnel to take CEP Certification courses
Creating accounts in PPLS
Creating accounts in LOS
Changing your password
Understanding who has access to LOS
Assigning personnel to a research project
Adding and deleting personnel from a research project
Creating and submitting activity logs
The importance of the LOS summary page

10. Gaining Access to LOS
Inviting Personnel to Create Accounts Creating PPLS Accounts and taking Certification Courses Creating LOS Accounts Setting and changing your Password Logging in and Troubleshooting

11. Getting started Before anyone can access LOS they must have:
Been invited to create an account in LOS and
Completed the CEP Certification courses in PPLS.
Only personnel who have completed the CEP Certification courses will show up in LOS as eligible to work on a project.
Not everyone needs to create an account in LOS.
You do not need to have an active account in LOS in order to be added to a research project.
Only those people who will actually be creating activity logs are required to create an account.
As long as you complete the CEP Certification courses, your name will appear in LOS and you can be added to a project, without having created an account.

12. Inviting personnel to LOS and PPLS
First step in the process is sending an invitation via LOS.
This can be done by the vendor project manager or by Pfizer. For firms new to LOS, the initial invitations will come from Pfizer. After that, the vendor will be responsible for inviting new colleagues, including subcontractors and recruiters.
The invitation will provide a link to take the training in PPLS and, if necessary, create an account in LOS once training is complete.
To send out the invitations, click the ‘Vendor Account Management’ button on the top left corner of the dashboard.

13. This takes you to the “Vendor Account Management” screen
Anyone in your organization who already been invited to create an account will show up in the box.
If others in your organization (including subcontractors and recruiters) will need access to LOS and/or the safety training, then you need to click the “Invite New Personnel” button.

14. Inviting new personnel
Begin by selecting your organization from the drop down menu
Next, add the s (please do not use personal accounts)
Separate each with a comma (or use separate lines)
It is also fine to cut and paste a long list of names

15. Inviting new personnel (continued)
Once you have everyone’s address that you would like to invite, click the “Verify Users” button.

16. Inviting new personnel (continued)
If you have entered a valid address, the system will return a “verification successful” status.
If you’ve made any errors (such as rather than .com) the system will return an error message
If you’ve entered an address of a colleague who has already been invited, the system will alert you to that as well.
Once the s are verified, click the “Proceed to Invite” button

17. Inviting new personnel (continued)
When you click the “Proceed to Invite” button, the system will show you the following message:
Just click “OK”
Once your personnel receive the invitation, they can go directly into PPLS to create their accounts and take their training.

18. Invitation s
This is the that people will receive when they have been invited to create an account and/or complete the online training:
You must always use the exact address that is shown in the invitation .
Once you create your account in PPLS, it generally takes 1-2 days for it to be approved by Pfizer. Once approved, you will be notified by the system and able to access the required training modules.
You must complete the CEP Certification courses before you attempt to create an account in LOS. Please note that it takes 24 hours for PPLS to update LOS with record of your training.

19. PPLS Landing Page
When you click the link in the from LOS, it will bring you to this page.
Click on the “Create your own account” link to set up your account in PPLS.
Input your address as your username
You will also designate your password.
Remember – it takes 24 hours for Pfizer to approve the creation of your account.

20. Register for the CEP Certification course in PPLS
Click the ‘register’ button.

21. Completing both CEP Certification Courses in PPLS
These are the two courses the comprise CEP Certification
To take the courses, simply slick the ‘start’ button.
When you’ve completed both courses, you will be able to create an account in LOS. Please note it usually takes 24 hours for PPLS to update LOS.

22. Completing both CEP Certification Courses in PPLS
After completing the first course, you may need to use the dropdown to display the second course

23. Accessing LOS
Once you’ve completed your CEP Certification in PPLS access the LOS system
This will bring you to the log-in screen.
System shows GMT on every screen
Click “Get Support” to submit a help desk ticket
Click the “?” to access LOS Help
Username is your address – the one you used to create your account in PPLS
To create your account, click “I don’t have an account yet” to begin the process.
At the bottom are links to the privacy policy, terms of use, contact us and announcements.

24. Accessing LOS– creating your account
When you click “I Don’t Have an Account Yet”, the following will appear on the login page. Enter your address (which will be your username going forward), the letter/number combination from the captcha and then hit ‘submit’.
The system will send you a link via that you will use to access the system and create your password.
When you receive the , simply click on the link, enter your username and then select the password you want to use.

25. Accessing LOS – resetting your password
If you forget your password, or need to reset your password, click ‘Forgot Password? on the login screen. As with creating a new account, you should enter your address, the letter/number combination from the captcha and hit submit. The system will you a link to LOS that will allow you to reset your password.
Please note that your passwords will expire every 120 days.

26. Logging into LOS When you log into LOS for the first time:
The system will present you with a link to download LOS system training material. You will be required to certify that you have reviewed the training material before you can start using the system.
The system will also present you with the ‘Announcements’ box which will display any new messages from the system.
You can select the ‘Do not show this message again’, and it will not appear each time you login. Any system announcements are also available on the dashboard.

27. Troubleshooting LOS login
If you are unable to logon to the system, LOS will let you know the reason why.
The most common reason for inability to access is that you are not assigned to an active CEP.
Vendor personnel are only able to access LOS if they are either the Vendor Project Manager for a market research program, or have been assigned to the market research by the Vendor project manager.

28. Navigating the LOS dashboard Adding Personnel to the CEP
Getting Started
Navigating the LOS dashboard Adding Personnel to the CEP

29. CEP LOS dashboard
The landing page for LOS is the dashboard. It provides:
Search functionality for all of your Pfizer CEPs (active and closed)
List of your currently active CEPs (shown 5 at a time)
Your dashboard is automatically updated with new projects by the CEP inventory
Click on the CEP ID to bring up that particular CEP
You can access system training by clicking the link at the bottom of the page

30. Starting a new research project
When you click the CEP number on the dashboard, this is what you will see. Your first responsibility is to assign personnel to the CEP
This button is only visible to the Vendor Project Manager(s).
They should assign all personnel working on the project to the CEP
These people do not necessarily have to have an account in LOS, but they must have completed the CEP Certification courses in PPLS.
Only personnel who will be submitting activity logs need to have an account in LOS.

31. Assigning personnel – selecting the frequency of reporting
The first step involves selecting the frequency which with you will be submitting your activity logs. For primary market research the rules are:
If the study is internet based or mailed surveys, select ‘Daily’. Activity logs have to be submitted for every day. Activity logs for nonbusiness days can be submitted on the next business day or three calendar days, whichever is shorter.
All other studies should select the ‘As Needed’ option, meaning you will submit an activity log for only those days where there is two-way communication with a customer.
After you have made your selection hit the submit button. After that, the submit button will disappear. Once you’ve made your selection, you cannot change the reporting frequency.

32. Assigning personnel
Simply click he box next to the names of the personnel who will be working on the market research project. Then click ‘save changes’. A green box will appear to let you know that your changes were successfully changed.
Note that LOS displays six names and there is a scroll bar to access all personnel
Also, anyone whose training has expired, or will expire in 30 days cannot be assigned to a project until they re-take the training modules in PPLS.

33. Assigning personnel
You will now see those names shown at the top of the screen as being assigned to the research project.
If you need to remove someone from the project, simply access the Vendor Personnel Assignment page and uncheck their name. If one of your employees should leave your organization, or no longer work on Pfizer projects, unassign them from any active projects and to have the account deactivated.
You can add or remove personnel at any time during the project.

34. Adding personnel outside your organization
You have the ability to include people outside your organization
Recruiting agency personnel and subcontractors, such as moderators, simultaneous translators, etc.
If they are in LOS, but they were added & trained by a different vendor:
If these people are not already in LOS:
Send them an invitation through LOS for the CEP Certification courses in PPLS
Going forward, simply add them to a project in the same way as you would employees of your firm.
Type in their address and hit the “Add” button and then the “Save Changes” button. If they are trained and in the system, they will be added to your list

35. Submitting Activity Logs
When to Submit Activity Logs Accessing the Activity Log Page Completing the Activity Log Closing out the project in LOS

36. When to submit an activity log
For internet based and mailed surveys, you will need to submit an activity log daily
You are not required to submit activity logs on weekends, following the AE submission requirements of every business day or 3 calendar days, whichever is shorter.
You can submit the activity logs for weekend activities on Monday.
For qualitative and other types of research, you will submit an activity log for each day there is two-way interaction with customers.
This means that you do not have to complete an activity log on days where you are not conducting interviews or having other contact with customers..
The system will know not to expect a report until the date you specified as your next follow-up date.
If the study requires recruiting, and recruiting involves two way interactions with customers, then an activity log must be submitted every day that recruiting is taking place.
If the recruiters are not working on Saturday and Sunday, then you do not need to submit activity logs for those days. When you submit Friday’s report, indicate that the next follow-up day is Monday.

37. Adding a new activity log
Below the report summary is the ‘Add/Update Activity Log” link.
This link is not visible until the vendor project manager has selecting the reporting frequency and assigned personnel to the CEP.
Any vendor personnel having an account in LOS and assigned to the CEP can submit an activity log.
To begin submitting an activity, simply click the link.

38. Creating an activity Log
When you hit the “Add/Update an Activity Log” you are taken to this page.
Simply click the link “Create Activity Log” to get started.

39. CEP activity log screen
This is the screen that you will see when adding / updating an activity report.
Many fields have drop- down menus
If you make a mistake, you can hit reset, and the system will erase all entries.
Log Frequency, shown at the top, is not updateable.
The following slides will demonstrate how to complete an activity log.

40. Creating an activity log – Country of Conduct
Under “Country of Conduct”, you should select the country for which you are submitting an activity log.
You should submit separate activity logs for each country in which the study is being conducted.
Begin country submissions when two-way communications with customers begins in that country.
If you select a country that was not included in the CEP created by your Pfizer BAI program manager, you will see the message shown below
You can submit the activity log for the country if you are, in fact, conducting interviews there. BAI will be automatically notified that they need to update the project in the CEP inventory.

41. Creating an activity log – Activity Stage
Activity stage has two options:
Pre-engagement – this option is selected for recruiting activities only.
Engagement – this option is selecting for the actual interviews, surveys, etc.
This is the default option in LOS
This allows Pfizer the ability to monitor adverse events that are attributable to recruiting activities versus those from the actual research.
LOS will allow you to have two activity logs per country per day to account for situations where you are recruiting respondents and engaging in research activities:
1 activity log for recruiting and 1 activity log for engagement.
If you are not using recruiters (internal or external), you will only use the “Engagement” option.

42. Creating an activity log – Activity Log
The date you enter represents the 24 hour period for which you are submitting the activity log. It does not refer to the date on which you are submitting the log.
This is critical because the first activity log represents ‘documented evidence’ (for audits and inspections) of the actual start date where two-way communication commenced.
The last activity log represents ‘documented evidence’ of the actual date on which two- way communications ended.
Example: Qualitative interviews began on Monday, June 6th. On Tuesday, June 7th, you access LOS to enter the information for Monday’s interviews. The date you select for the Activity Log is June 6th, as that is the date on which the activities took place.
Example: Your internet survey went live on Wednesday, March 16th. On Thursday, March 17th, you access all of the data from March 16th and review for potential product safety reports. When that is completed, you access LOS and enter the activities. The Activity Log date should be March 16th.

43. Creating an activity log – Reason for Late/Updated Log
If the system detects that your activity log is late (e.g., more 24 hours past the required activity date), then the drop down menu becomes active.
LOS does, however, account for weekends, so activity logs for weekend days are not considered late if they are submitted on Monday.
LOS does not account for holidays in any country, so use the general comments field to account for any late report due to a holiday.
You must select one of the reasons in the drop down menu, or select the “other” option.
You will then be asked to specify why the log was late / updated.
You will not be able to submit a late / updated activity log until the reason is selected.

44. Creating an activity log – Number of Interactions
For primary market research, interactions refer to:
Total number of completed internet, paper or face-to-face surveys
Total number of respondents contacted (where two way communication was established) during recruiting
Note: unanswered s, busy signals, no answer or hang-ups do not count as interactions – they can be ignored. There must be some level of contact established.
Total number of one-on-one interviews completed during the reporting period
Total number participants in focus groups completed during the reporting period.
Remember, this is the number of interactions that took place on the date for which you are submitting the activity log. This is not a cumulative number.
In other words, the sum of all interactions at the end of a project will equal your total sample size.

45. Creating an activity log – Number of Unfinished Interactions
‘Unfinished Interactions’ is only used for internet-based surveys:
Refers to partially completed surveys (that must continue to be monitored daily until the respondent finishes the survey, or the survey is closed to respondents).
Example: A physician begins a lengthy survey on Sunday evening, completes half of the survey and hits save. On Monday, when the data is reviewed, this physician’s responses would be considered an unfinished interaction. There is the possibility that the physician could change answers or mention a adverse event when the he/she completes the survey. On Wednesday, the physician returns to complete the survey and hits submit. On Thursday, when the data is reviewed, this physician’s responses would now classify as an interaction.
Also includes everyone who is screened out of an internet survey (e.g., they completed the screener, but did not qualify for the main questionnaire).
Example: Data from an internet study is reviewed on Tuesday for the surveys that were begun/completed on Monday. Thirty five patients attempted the survey but didn’t pass the screening criteria. All 35 would be counted as unfinished interactions.
For non-internet based research, just enter ‘0’ in this space
For internet based research, enter ‘0’ only if there were no incomplete surveys or screened out respondents.

46. Creating an activity log - Number of Product Safety Reports
Number of Product Safety Reports – indicate the total number of product safety reports that were submitted to Pfizer’s Drug Safety Unit (DSU).
Submit only the number of product safety reports for the 24 hour period for which you are completing an activity log.
Product safety reports include: adverse events, “at risk” scenarios—that is, circumstances leading to increased risk for an adverse event (such as exposure during pregnancy, exposure during breastfeeding, medication errors, off label use), product complaints, and medical device complaint reports
If there were no product safety reports submitted to the DSU for that activity period, then enter “0”.

47. Creating an activity log – Delayed Product Safety Report
Delayed Product Safety Report – check this box if you submitted a product safety report to the DSU more than 1 business day or 3 calendar days after discovering the adverse event or other product safety issue.
When this box is checked, you must include a reason for the delay from the drop down menu (which only becomes visible if you check the “Delayed Product Safety Report box).
As with updated activity logs, there is also an “other” option.
In the ‘General Comments’ box, please indicate how many reports were submitted late (if the number of product safety reports is greater than 1).
Note: An upcoming version of LOS will have a field that will allow you to specify the number of late reports

48. Creating an activity log – General Comments
LOS provides a ‘general comments’ box to allow you to annotate any activity log.
Examples of annotation include:
Number of late product safety reports
Reason why there were no interactions on a particular date
Reason why an activity log was created before one was expected
Track ID number of online surveys you’ve reviewed
Please do not provide any confidential information or product safety reports in the general comments box.

49. Creating an activity log – Next CEP Activity Log Actions
Next CEP Activity Log Actions refers to the next day on which you will be accessing LOS to submit an Activity Log.
For Daily, Weekly and Monthly frequencies, the activity date will automatically populate.
For ‘As Needed’ projects, you will have to enter the date.
Important: The date you select for the activity log represents the date the actual interviews or surveys took place.
However, the ‘next CEP Activity Log Actions’ refers to the next time you will access LOS to submit an activity report.
Example: I submitted an activity report on Thursday, January 21st for all interviews that occurred on Wednesday, January 20th. My Activity Log reflects the date, January 20th.
The system knows I entered this data on January 21st, the frequency of interactions is daily, so LOS expects me to enter another activity report on Friday, January 22nd, to reflect the activities that occurred on Thursday.

50. Creating an activity log – FAQs around ‘Next Activity Log’ for ‘As Needed’ projects
What happens if I’ve indicated my next activity log date in LOS for an ‘as needed’ project, and the interviews that were to take place on that day are cancelled?
Simply go into LOS, enter the activity date and enter “0” for complete, incomplete and product safety reports. In the ‘general comments’ space, it would be helpful to type in the fact that the interviews scheduled for that date were cancelled.
What happens if I add interviews that will take place before the next activity log date that I indicated on my last activity log?
On the day the interviews take place (or the next day), access LOS and complete an activity log as you normally would. The system will not prevent you from completing an activity log prior to your ‘next activity log’ day.
You would indicate the ‘next follow-up day’ as the date from your previous activity log.

51. Creating an activity log – submitting the activity log
Once all of your information is complete, hit the ‘submit activity’ button.
Creates a record of your activity log
Date/Time stamped (using Greenwich Mean Time)
Person completing the report is identified
Cannot be altered by anyone at Pfizer
If you’ve made mistakes or left out required information, the system will alert you to make the changes. When you have successfully submitted an activity log, you will see the following:

52. Submitting a late activity log
There may be times when you will have to submit an activity log late due to situations beyond your control:
Internet outage
LOS system not available
Holiday
The process for submitting a late activity log is same. The only addition is that you must provide a reason for the late activity log in the ‘Reason for Late/Updated Log’ box.
And remember to select the appropriate date (e.g., the date on which the interviews, surveys, etc. took place).
Example: If you had 8 interviews on January 19th, but the internet was down until January 22nd, and you go into LOS on the 22nd to submit that activity log, the activity log date would be January 19th.

53. Making changes to an existing activity log
To make a change to an activity log that you have already submitted:
From the dashboard select
All of your previously submitted activities are available
In the column marked “select”, choose the activity log that you need to modify. Note that the ‘Update Activity Log’ button does not become active until you select an activity log to update.

54. Making changes to an existing activity log
Once you select the report you want to update, it will appear directly below the ‘Report an Activity’ box.
Simply make your changes and provide the reason for the change – LOS will not allow you to submit a change without providing the reason.
Log Frequency, Country of Conduct, CEP Stage, Activity Log date, and Next CEP Activity Log Actions are not editable.
Hit submit activity, and the ‘activity log Summary’ will display the most current log.
Audit trail showing all changes to Activity Logs.

55. Closing out your project in LOS
When you submit the last activity log for a country, select ‘No further interactions with customers in that market and activity stage Engagement
When you make this selection, LOS will show the following summary. If the research is conducted in multiple countries, it will show the summary status for each market.

56. Closing out your project in LOS
Important - For research projects using recruiters
You must select ‘No further interactions with customers in (country) for both activity stages (engagement and pre-engagement).
When you submit your activity log for the last day of recruiting, select ‘No further interactions with customers in (country) for activity stage pre- engagement.
If the activity log represents the last activity log for all countries in which the study was conducted, and all stages, you will see the following:
Click Yes, and then submit the activity.

57. Closing out your project in LOS
Even though you’ve indicated that the activity is complete, you will still have the ability to make changes or updates until the project is officially closed by BAI in the CEP inventory.
BAI will close out the project in CEP no later than 30 days after you submit your final activity log (and indicate that activity is complete).
If you get close to the 30 day time frame and realize that you need additional time, just contact your BAI project manager and ask him/her to delay closing the project in the inventory.

58. CEP Summary Page The CEP Summary Page includes:
All information that was migrated from the CEP inventory
CEP Exceptions – areas where LOS and CEP Inventory do not match, late activity reports, etc.
Summary of the activities and Product Safety Reports.

59. CEP Summary Page (Continued)
The CEP Summary Page includes:
All of your activity logs (shown in groups of 5).
Information concerning vendor personnel assigned to the research and the dates of their training.
In the event of an audit, this is how you demonstrate compliance with CEP
Everything is exportable to Excel and printable.

60. Additional Topics: Navigating in LOS, Alerts, System Issues and Trouble- shooting

61. Navigating in LOS
The four buttons on the dashboard will take you to the areas within LOS: Vendor Account Management, CEP summary, assigning personnel and submitting an activity (assign vendor personnel will not be visible to everyone)
To return to the dashboard from these three areas, simply click “Back to Dashboard” at the top left of your screen
When you are finished, click “Log Out” at the top right of your screen

62. Alerts
The LOS system will send out a variety of alerts to you and to your BAI project manager:
Daily alerts to BAI summarizing the activity logs
Alerts to BAI when reporting has started, an activity log is submitted late, an activity log is submitted for a country not indicated in the CEP inventory and when an activity log is updated
Alerts to BAI when the project has completed fielding
For the vendors, LOS:
Alerts the vendor when an activity log is past due or training is nearing expiration
Copy of the daily summary of activity logs
All LOS communications go to the Vendor Project Manager

63. If There are Issues With LOS…
Should the LOS system be unavailable during the fielding of one of your projects, you should immediately revert back to the Excel Spreadsheet to capture reportable mentions.
Send the spreadsheet to your BAI program manager every day until the system is back up.
Once the system is accessible, enter all of the activities for the days that the system was down.
In the ‘Change/Delay Reason’ box, simply indicate that LOS was unavailable between _____ and ______.
Capture any vendor personnel changes after the fact, as needed

64. Troubleshooting If you experience technical problems with PPLS or LOS:
If you are able to get into the system, click “get support”.
You can report the issue from the ‘get support’ button.
If the system is completely down mail:
If you have process questions you can contact your BAI research project manager

65. Summary - goal of LOS is to make it easier for Pfizer and our vendor partners to comply With CEP policy
With LOS, it is no longer necessary to:
Complete the Excel template and that to the BAI project manager
Complete the certification of start date
Complete the certification of end date
Complete the Certification of AE training document for your employees and subcontractors
LOS is also a tool that provides external inspectors and internal auditors evidence of compliance with Corporate Policy 902 and 902a.
LOS will continue to improve with enhanced features.

66. Remember:
All primary market research projects conducted for Pfizer MUST use LOS.

67. Questions???