[Q&A] Risk-based Validation Considerations When Implementing Clinical Research Systems

Susan Nonemaker-Cox
Senior Associate, Essex Management
August 25th, 2016

As a follow up to her recent webinar, “Risk-based Validation Considerations When Implementing Clinical Research Systems,” Essex Management’s Senior Associate, Susan Nonemaker-Cox, provides answers to attendee questions.


If a sponsor purchases an off-the-shelf system, such as an EDC, and validates it, does it also need to be certified by a third party?


Typically, there should be a set of procedures to determine a validation or quality conclusion prior to implementation, as well as on an ongoing basis (e.g., periodic reviews, internal/external audits). Exacting that a system is “certified” by a third party might be required if the sponsor has a policy or procedure in place that promotes this expectation. A sponsor might choose to have independent reviews of the system performed by an in-house group or leverage an independent third-party, external organization. The more layers of quality assurance (e.g., independent review and assessment) definitely provide for more confidence in the overall validation effort and validated state of the system. The sponsor determines whether or not it is a required activity.


Is the risk-based validation approach only applicable to sponsors, or can it also be implemented in a hospital setting?


The risk-based validation approach can be applied to sponsor organizations, clinical research sites and medical institutions. It would be ideal to start with an initial validation strategy planning session; documenting the scope of the validation (and related systems and assumptions), the regulatory compliance determination and risk analysis, who is involved and what artifacts will be developed during the effort.


During the presentation, you mentioned a risk-based approach to 21 CFR Part 11. Are there specific types of data that should be compliant with this regulation and would all systems used for clinical research need to be GCP compliant?


Some system implementations are more complex (e.g., upstream and/or downstream systems providing data and/or transforming data, various modules included in a “system”). Depending on the size and complexity of the system and related data, there might be a requirement to build a Master Validation Plan (“validation wrapper document”) and then individual validation plans/protocols detailed to each system or module specific to that area. By forming that upfront GxP determination and Risk Assessment, you can break-down the specific scope of the system(s) and data. There might be a business rationale to have stricter validation controls in support of more regulated data based on how the system is setup. This initial validation planning and assessment phase is critical, as it helps to determine (and document) the basic assumptions and parameters for validation. This information and results or recommendations can be documented in stand-alone documents and then summarized and referred to in the Master Validation Plan or Validation Plan(s). Having this documented upfront, you can focus on stricter documentation and validation controls around the areas of a system or data which require more attention.

Compliance and Regulatory EDC

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