Clinical Research: Approving Studies Effectively

Our healthcare team were called upon to examine the existing processes for approving any new study at a major hospital trust in the northeast of England.

The studies were to include clinical research trials and were to improve efficiency.


days of delays were saved for every study submitted, improving the speed at which trials could start

Significant increase in teamwork between different departments

A of process clarity for all staff involved in workshops

Clinical Research: Approving Studies Effectively


The three-month programme resulted in:
• A transformation of communication between the research admin office and other teams, saving 4 days of delay for every study submitted.
• Clarity for all staff involved in the workshops, who were able to openly discuss and rework the way they viewed their processes.
• Greater teamwork between different departments, which encouraged unity and problem solving.

Clinical Research: Approving Studies Effectively


The biggest achievement from our observations was that the initial analysis highlighted a range of future measures which would continue to transform the approvals process. The 12 to 18 month programme currently being implemented is:
• Identifying project managers to coach and mentor.
• Developing a dashboard for delivery teams and senior managers to track progress.
• Encouraging weekly meetings to discuss critical process measures.
• Creating a best practice standard tool for all teams to measure themselves by.
• The overall aim is an internal system used by all staff for the long term to continually prioritise and increase high-value applications.

Clinical Research: Approving Studies Effectively


• A lack of ownership. Each department was taking a siloed approach without cross departmental coordination, which resulted in lengthy delays.
• Studies were prioritised in sequential order as opposed to their importance, resulting in a loss of high-value applications and deferring income.
• An absence of tracking systems to monitor data, KPI’s, targets or income
• 80% of applications were returned as incomplete and requiring amendment and up to 50% of trials were unnecessarily rejected.

Clinical Research: Approving Studies Effectively


Working with the teams we embarked on a three-month process:

STAGE 1: Conducted stakeholder meetings and process mapping workshops to determine each part played and encourage open discussion and honest analysis.

STAGE 2: Directed workshop reviews at each step to identify issues affecting the process. Created countermeasures including a local level Programme Management Office which allowed teams to track performance with metrics.

STAGE 3: Prioritised quick wins to introduce in the short term and developed a complex Master Schedule of work to implement over the next 12 months.