Organized Data Collection PV Obligations

Program/Material Review

100

How should Program Owners obtain PV input into the assessment of the PROGRAM's potential to generate adverse event reports?

Consult PV: 1. If Global MRP, Program Owner should consult Global PV 2. If Area MRP, Program Owner should consult Affiliate Vigilance Excellence (AVE) rep for the Area and Local Affiliate MRP Business Contact. Local ASR designated as "ASR Rapporteur" is expected to consult all other local PV, if necessary. 3. If Local MRPs and PSPs, Program Owner should consult Local PV (e.g., Austria, Brazil, Russia, Taiwan, USA)

200

How should Program Owners obtain PV review of program materials?

Leverage already established Material Review & Approval Processes (e.g., US uses ePass) Program Owner is responsible for documentating whether PV obligations apply to the program (including, if relevant, rationale for why obligations do not apply) and for securing the necessary PV reviews.

300

Who should be given the opportunity to review Program Materials?

Global PV (if Global MRP, US MRP, or US PSP) Local PV (if Local Program OR ASR assigned as Rapporteur for Area Program) Local and Area Business Contacts (if Global or Area MRPs)

400

What is the SOP that covers all requirements for these program types?

Q-15-01-019, Organized Data Collection Covers: 1. Patient Support Programs 2. Market Research Programs 3. Social Media Programs 4. Company-sponsored Websites

500

Name all SIX PV requirements addressed in Q-15-01-019

1. Program/Material Assessment 2. Service Provider Qualification 3. Service Provider Contract 4. Service Provider Training 5. Ongoing Monitoring of Service Provider Compliance 6. PSP/MRP Inventory Requirements

SP Selection & Training

100

True or False? Program Owners must always consult PV before selecting a service provider for their programs

FALSE! A PV consultation regarding the PV qualifications of a Service Provider is NOT required if the Service Provider listed on a "Preferred Provider" list. HOWEVER, this can only be the case IF PV has "baseline approved" all providers on the list and will be involved in decision-making around movement of providers on and off the list. Decisions regarding PV qualification of service providers for Global MRPs are made by Global PV (MSS). It is OKAY for local Affiliates to require PV approval of all Service Providers for local pograms (i.e., NOT allow the "preferred provider" exception). This is an individual decision to be made at each Affiliate.

200

Vendor Qualification Assessment (VQA) is required for what FOUR types of Organized Data Collection?

1. Patient Support Programs 2. Market Research Programs 3. Social Media Programs 4. Company-Sponsored Websites VQA may refer to activities supporting the initial vendor selection OR to assess a chosen service provider for their compliance capability

300

True or False? Program Owners are responsible for confirming that Service Providers have been trained appropriately before the program is initiated?

TRUE!

400

If a Global Service Provider is being used for a Global Market Research Program but is subcontracting to non-Affiliated companies in local countries of conduct, is one VQA of the Global Service Provider sufficient?

Yes

500

How do local Affiliates access information / evidence regarding training of Global Service Providers?

Contact GPV, MSS. (Arlene Camasosa, Akeesha Patel, or Jill Beaudry) MSS is assessing options for making this information available to Affiliates.

Contracts

100

In what SOP can the template PV language for ALL Service Provider Agreements be found?

Q-15-01-018, Safety Data Exchange & Other Pharmacovigilance Agreements Reminder - the decision tool can be found in Q-15-01-018-W001, Selecting Pharmcovigilance Contract Language

200

Where do you go to find Template #01 for SERVICE PROVIDER Agreement language?

QDMS/QMD/Sentinel/Process Map Q-15-01-018 Template 01 - Service Provider PV Template

300

To whom must all signed PV Agreements (SDEA and Service Agreements) be sent?

The SDEA group in QSCTO via email to "GPRD_GPV_SDE" Reminders - 1. In English 2. Within 30 Days 3. Including notification that a contract has been terminated or expired

400

True or False? PSP & MRP Contract Compliance metrics are reported routinely to GPV Leadership, the EU QPPV, and AVE?

TRUE! Data from the "Compliant Service Provider Agreement?" field from the PSP/MRP Inventory is pulled on a monthly basis and reported to these individuals. They will also soon be included in the PSMF. Reminder - any time the template is updated, program contracts should be assessed to determine whether an update is required. If required, the Inventory field status should be changed to "NO" (not compliant), and a target date for completion of the contract update should be entered. NOTE: compliance figures for April 2013 were: PSPs - 97.1% MRPs - 89.0%

500

What is the Medical Director required to do annually where contracts are concerned?

Attest that the template being used by the Affiliate contains all required PV language

SP Compliance

100

What is the Service Provider compliance monitoring tool that, at a minimum, should be assigned to EVERY program in the inventory?

Reconciliation

200

Name 3 additional activities that can be used to monitor Service Provider compliance with PV obligations.

1. Follow up on non-compliances (e.g., emails) 2. Self-completion questionnaires requested and received from partners 3. Audits planned or conducted (including findings/outcome) 4. CAPAs requested 5. Face-to-face meetings that discuss programme issues 6. Teleconferences that discuss programme issues 7. Close monitoring activities implemented

300

At what minimum frequency do results of ongoing monitoring activities need to be communicated to R&D QA PV Compliance?

Quarterly

400

What tool should Affiliates use to communicate results of ongoing compliance monitoring activities?

The "Affiliate Partner Monitoring" SharePoint Site

500

Who is responsible for ensuring the conduct of Affiliate Partner PV Audits by approved qualified auditors?

Affiliates Reminders - 1. Affiliates should discuss any audits with R&D QA PV Compliance at the planning stage 2. Q-01-02-011 and Q-01-02-011-W001 outline the process for conducting Partner Audits 3. Third parties used for audit purposes are identified in the PV System Master File

The Best Inventory EVER

100

According to Q-15-01-019, who is responsible for entering their own program information into the MRP Inventory?

Market Research Program (MRP) Owners

200

HELP! My NEW Service Provider is not listed in the Inventory pick list. What do I do?

Submit a help desk ticket (via the "Inventory Help Desk" button) on the main page of the Inventory.

300

True or False - an ASR could be responsible for overseeing PV obligations for a Market Research Program that is NOT the responsibility of his/her local Affiliate.

TRUE! An ASR could be designated as the "Rapporteur" for an "Area" Market Research Program. Oversight of all PV Obligations is then the responsibility of that ASR.

400

What number should be entered into the "enrollment" field - current enrollment, or program-to-date enrollment?

We will accept either answer today, but this will change. We recognize this is not clear in the field guidance. We are obtaining feedback on this and will change the field guidance ASAP to clarify.

500

What were the 2 Inventory-related issues cited by MHRA in the PV Inspection Report?

#1 - blank "End Date" fields #2 - disparity in enrollment values Reminder - please ensure there is a projected end date for all "ongoing" programs and an actual end date for all "complete" programs. Inventory 2.0 will contain logic that will force attention to these fields, but we need your help now to address this during the routine update process.