TrialScope is part of Informa Pharma Intelligence, a division of Informa Business Intelligence, Inc. (IBI). IBI is a wholly-owned subsidiary of Informa PLC.

This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Top 5 Best Practices for Clinical Disclosure SOPs

Thomas Wicks

May 21, 2018

MAY 21, 2018

Clinical trial disclosure requirements are growing globally with regulations in over 90 countries and continuously evolving data sharing norms based on increasing transparency. In this dynamic environment it can be challenging to develop relevant SOPs, but here are five best practices based on over a decade of experience working with the leading trial sponsors. 

1. Implement a clear and generous transparency policy

The best way to ensure alignment across the organization and communicate the corporate commitment to transparency, is to implement a global data sharing and transparency policy that is both specific and generous in anticipation of rapidly evolving trends.

Note: Developing a policy that anticipates transparency trends and peer commitments, as well as the evolving expectations of transparency advocates and patients may require working with an external disclosure expert.

2. Create a cross-functional clinical transparency committee

Foster coordination and commitment across departments and regions by creating a cross-functional panel of disclosure stakeholders. Such a panel, or committee, would typically consist of the chief medical officer (or representative), clinical operations, biostatistics, publications and regulatory affairs, although others may need to be included to meet the needs of your organization.

3. Focus SOPs on high-level processes, roles & responsibilities

Since regulations and transparency trends continue to evolve, TrialScope recommends keeping SOPs at a high level to outlines the processes, roles, and responsibilities for disclosure. These high-level SOPS would then be augmented by supporting documents (see next point) to address specific details. This will reduce the often-cumbersome effort of updating and approving SOPs as disclosure and transparency requirements evolve.

4. Move detail to supporting documents

Having a high-level SOP requires detailed supporting guidance documents, work instructions, process diagrams, and detailed roles and responsibilities charts (e.g., RACI diagrams). These detailed documents are usually less onerous to update and would include information that is likely to evolve over time, such as manual and automated processes, source systems, disclosure technologies, trial registries, and data sharing platforms.

5) Update related SOPs

Don’t focus exclusively on disclosure and transparency SOPs. Disclosure and transparency is reaching into many unexpected areas of an organization. Consider updating SOPs that are related to disclosure. For example, full protocols are becoming public, albeit lightly redacted. Does your protocol SOP include the best practice of including the disclosure team in the protocol finalization process to ensure that the document is appropriate to be in the public domain? Other areas that my need consideration are publications, investor relations, medical information and regulatory affairs.

As clinical disclosure requirements continue to evolve, you can keep your organization ahead of the curve by considering these five best practices. For more information and to discuss TrialScope’s advisory services, please contact:

About the author

Thomas is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. Thomas has been focused on trial transparency since 2007.