What’s New in E6 R3? Sponsor Responsibilities, Part 2 – Financing and Agreements

Dust off your Montblanc pen!  Next in our series on what’s new in E6 R3:  Financing and agreements.  A new section collects some of the statements on contracts previously scattered throughout R2 and adds new requirements.

Requirements carried over from R2:

• Sponsors and clinical sites must document their financial arrangements in an agreement.
• Responsibilities assumed by a service provider must be documented in an agreement.
• Any responsibilities not explicitly transferred are assumed to be retained by the sponsor.
• The sponsor retains ultimate responsibility for transferred activities.

New and changed requirements:

• Sponsors should ensure appropriate oversight of important trial-related activities that are contracted and subcontracted. This general requirement was seen in R2; however, the words “appropriate” and “important” were added, perhaps to emphasize risk-based oversight.
• Agreements between the sponsor and investigator, coordinating investigator, service providers, committee members, and other parties must be in place before activities are initiated and updated when responsibilities change.
• Contracts or other agreements should capture the contracted party’s commitment to conduct studies per the protocol and GCP; comply with procedures for data recording and reporting; retain records for the entire retention period; and permit monitoring, auditing, and inspection.  The first three requirements were previously specified in R2 for clinical sites, but not for service providers or committees; the last was required for all parties in R2. Based on recent inspection activity, we recommend that all contracts include a statement saying that contracted party will comply with GCP.
• Service providers used for clinical trial activities should implement appropriate quality management and report issues with potential impact to participant safety and data integrity to the sponsor.   R3 does not explicitly state that these requirements must be outlined in an agreement, but since this statement appears in the Agreements section, you do the math.
• Sponsors are responsible for assessing the suitability of service providers to undertake the contracted services and should have sufficient access to service provider SOPs and metrics to make this assessment.  Believe it or not, until this point there has been no GCP requirement for sponsors to qualify service providers.
• If the sponsor hires a service provider to support an investigator, the sponsor should provide the investigator with information about that service provider, but the responsibility for oversight of the service provider lies with the investigator, even if the sponsor holds the contract. This new statement in R3 addresses a growing trend of sponsors’ hiring staff to augment site operations and provide other specialized services.
• If a trial has more than one sponsor, the sponsors should document each sponsor’s role and responsibilities. If a responsibility is not attributed to one sponsor or another, then all sponsors are responsible.  This new requirement speaks to situations where sponsors collaborate on studies or divide responsibilities for different regions.

Just plain confusing:

• “Trial-related activities performed by service providers should be conducted in accordance with relevant GCP requirements, which may be fulfilled by a service provider’s existing processes.” We reproduce this sentence verbatim to point out some syntax challenges.  What may be fulfilled by a service provider’s existing processes – activities?  GCP requirements?  It is not clear which noun the clause modifies. Let us know your thoughts!