Supplementary Guidance for Service Providers, Distributors, and Contractors
Roche functional managers and their service providers / third
parties must ensure that all of their appropriate employees and
employees of sub-contractors have undergone Safety Reporting
training (e.g. Roche Products Vigilance Training) to a standard
acceptable by Roche.
The training must be completed and documented prior to the commencement of any activities. Service Providers / third parties must ensure that any new direct employee or employee of sub-contractors shall also complete training prior to becoming involved and before starting any activities.
The Service Providers / third party shall ensure that all of their appropriate employees and sub-contractors have undergone Safety reporting training. The training must be completed and documented prior to the commencement of any activities covered by SRD-0125824.
The Service Provider / third party shall archive training records with the corresponding training documentation and shall provide any such records to Roche / Genentech upon request. Other supporting process documents or access to systems, such as reporting forms or access to reporting systems, can be provided by Roche. The Roche responsible will find all relevant information and resources on the internal Roche Product Vigilance Web Site.
The relevant reporting process, including reporting forms, and training materials are provided on this website for those who do not have access to Roche internal email address / password. In addition to the Roche Vigilance training the below definitions should be considered.
Submitting course certificate to roche functional Manager:
For personnel who do not have a Workday record, a certification of completion documentation should be stored locally, or for service providers / third parties, in accordance with the terms of the contract. The Roche line manager, or Responsible person for service provider contracts, may be contacted for guidance if not sure.
Important: Evidence of training completion must be provided to Roche upon request.
Definitions for Pharmaceutical Service providers/Third parties
Case Transmission Verification (CTV): The process of verifying that all AEs/Special Situation(s) sent to the Roche Drug Safety department by a Service Provider /third party have been successfully received by the Roche Drug Safety department. Causality Assessment Assessment of whether a causal relationship between a medicinal product and an Adverse Event or a Special Situation Report is at least a reasonable possibility. The causality assessment states whether an Adverse Event or a Special Situation Report is Related or Not Related to the medicinal product.
Source Data Quality Check (SDQC) (if applicable): The process of reviewing source data in order to assess whether the Service Provider / third party and/or another third party (e.g., Health Care Provider [HCP] on behalf of Roche) and/or Roche personnel running the program, have adequately identified and reported Adverse Events/Special Situation.
Causality Assessment: Assessment of whether a causal relationship between a medicinal product and an Adverse Event or a Special Situation Report is at least a reasonable possibility. The causality assessment states whether an Adverse Event or a Special Situation Report is Related or Not Related to the medicinal product.
Date of Initial Receipt And Minimum Data Elements: The date either Party (including any personnel of either Party or agents acting on behalf of either Party) has received the minimum data elements, as defined by ICH E2A guideline:
- An identifiable patient
- An identifiable reporter
- A suspect drug
- An AE(s)/Special Situation(s)/Product Complaint(s) (with or without an AE)
Note: If you do not have all the above four elements you should still report the AE(s) / Special Situation(s) / Product Complaint(s) (with or without an AE)