Designing Fit-for-Purpose GCP SOPs: Agreeing on Approach

In our last blog posts, we examined how clinical research ended up with overly detailed SOPs (our GMP heritage) and whether regulations require us to have SOPs at all.

Let’s assume we’ve decided to develop SOPs. What approach do we take to meet the needs of GCP?

In addition to considering regulatory requirements, we have to consider the needs of our organization, which are driven by the  following factors:

• Size of the Clinical Development team, or number of people fulfilling functional roles in Medical, Clinical Operations, Biostatistics, Statistical Programming, and Pharmacovigilance
• Experience level of staff in Clinical Development
• Expectations for growth – in other words, how rapidly Clinical Development is expected to add members
• Number of studies being managed by the organization
• Level of specialization for roles in Clinical Development- e.g., is everyone in a function performing the same role, or is there a hierarchy of directors, managers, leads, assistants, etc.?
• Sourcing strategy – i.e., are studies outsourced, conducted in-house, or some combination?
• Study complexity, including number of vendors, duration of studies, number and type of observations and procedures, and complexity of study designs.

If we consider each of these factors along a continuum, Visual Analog Scale-style, it might look like this:

Then we could assess our organization according to these criteria. A small biotech with an experienced team wearing “lots of hats” and outsourcing its single Phase 1 study would fall at the left side of the continuum.  A large CRO would fall at the right side.

Organizations on the left side of the continuum benefit from a few, cross-functional, high-level SOPs that outline the minimum steps required to oversee vendors. With few studies to manage and few people to manage them, they are not going to be repeating processes frequently enough to benefit from a lot of detail.  For this type of organization, we typically recommend one clinical study oversight SOP that traces the entire clinical study process from planning to closeout.  This SOP is the scaffold on which the GCP quality framework is built.

As an organization grows in terms of people, studies, and complexity, moving toward the center of the curriculum, supporting SOPs for Work Instructions can be added to support that clinical study oversight SOP when the need arises. For example, when a team goes from managing one study a year to three studies a year, they may benefit from a more rigorous protocol development process that includes the blessing of a protocol committee or a standard form for documenting quality control reviews. As a small start-up hires functional area experts – a Data Manager or a Safety physician, for example – those functions might benefit from their own oversight SOPs, and as they take on more activities in-house, more supporting SOPs to describe those tasks. As these organizations change and grow, they will repeat processes frequently enough to discover the most efficient way to perform them. That is the time to codify these processes.

At the right side of the continuum, large organizations with specialized roles require processes that promote consistency and efficiency across a large staff.  These organizations benefit from detailed, functional level processes, with a cross-functional framework that shows how they are tied together.  This framework might be a policy, an SOP, or just a chart. Most large organizations have a hierarchy:  cross-functional SOPs and functional work instructions, supported by forms, templates, and job aids. The trend we see, however, is toward simplification. Years ago, a large pharma or CRO might have hundreds of SOPs developed willy-nilly over the years. Now, large companies are forced by mergers and acquisitions to take a top-down approach to quality system design during integration, which usually results in a more streamlined set of processes.

In any case, the approach to SOPs should be dictated by the needs of the organization rather than tradition.  As we saw in our last post, there are few regulatory requirements for SOPs. In our next post, we’ll look at the cost of SOPs.