Vendor Scope
What is the purpose of the Vendor Oversight SOP?
To describe how to oversee vendors used to provide services related to the conduct of an AbbVie-sponsored study.
When should a Vendor Oversight Plan be developed?
Following execution of the vendor agreement.
How many Vendor Oversight Plan templates are referenced in the SOP?
Ten (10) templates.
Once a Vendor Oversight Plan is finalized, what must be done with the activities described in the plan?
They must be conducted and documented.
Name one type of study covered by this SOP.
Examples: Phase 1-4 Interventional, Non-Interventional, Affiliate-managed Non-Interventional, Medical Device/IVD studies, or eligible Collaborative Research studies.
Who is responsible for developing and maintaining the Vendor Oversight Plan?
The Individual Accountable for the Outsourced Activity.
Which Vendor Oversight Plan template would be used for oversight of a Contract Research Organization (CRO)?
Vendor Oversight Plan – Contract Research Organization (T02).
What two documents are identified as Master File Documents in the SOP?
The Vendor Oversight Plan and documentation of activities outlined in the plan.
What type of service providers are specifically excluded because they provide routine, short-term, or one-off services?
Transactional service providers.
What three factors may require a Vendor Oversight Plan to be revised?
Changes to the study, program, or services.
Which template would be used when no specialized template applies to the vendor?
Vendor Oversight Plan – Other (T06).
Why is documentation of oversight activities maintained?
To demonstrate that planned vendor oversight activities were performed.
Name three vendor types or entities specifically excluded from the SOP.
Examples: Staff augmentation, drug depots, equipment vendors, transactional service providers, investigational sites, or Phase I units.
What additional information must be included whenever a Vendor Oversight Plan is updated?
A brief summary of changes.
Name four vendor types that have dedicated Vendor Oversight Plan templates.
Examples: Central Laboratory, CRO, Imaging, IRT, EDC, eCOA, Functional Service Provider, Advanced Clinical Biomarker Laboratory, or Oncology Early Development CRO.
What is the accountable individual's responsibility when vendor oversight requirements change during a study?
Review and revise the applicable Vendor Oversight Plan and document the changes.