Whether building a new clinical research program, or continuing the development of an established organization, site efficiencies should be a top priority for your site. Developing consistency within an organization establishes solid research program efficiencies and allows sites to run at maximum capacity while minimizing potential compliance pitfalls. By following the steps below, your clinical research program will have the fundamentals in place to build a strong foundation for success.
Standard Operating Procedures (SOPs)
As discussed in our blog, Standard Operating Procedures: Who Needs Them and Why, the development of SOPs is critical to the efficient management of clinical trials operations. Developing SOPs for your organization ensures your staff has a clear understanding of internal processes and procedures, creates a consistent and streamlined program, and provides confirmation to outside regulatory agencies and sponsors that your organization is well-run.
After SOPs have been created, periodically reevaluate your processes to ensure the organization is adapting to changes within the industry. Taking the time to reassess organizational procedures will create opportunities to regularly implement newer and better practices that can ultimately lead to higher efficiencies.
Throughout SOP development and reassessment processes, provide regular training to clinical research staff to make certain they are up-to-date on all standardized procedures. The work a clinical research staff is conducting should be consistent with the steps outlined within the organization’s SOPs. Common processes that often necessitate SOPs include, but are not limited to, consent process, drug storage, accountability and destruction, and delegation of authority.
One of the easiest ways to ensure consistency within a clinical research program is by establishing a standardized fee schedule to be used during Clinical Trial Agreement (CTA) and budget negotiations.
Fee schedules should be consistent across an entire institution to assure fair market value and compliance. In order to establish uniformity within your fee schedule, work within your organization to develop normalized pricing in budget development, including instituting per subject payments, institutional fees, staff allocation and hourly rates, ancillary services and various budget line items.
The key to developing a standardized fee schedule is understanding site costs and having the ability to justify the reasoning behind these costs to the sponsor.
Clinical Trial Agreement (CTA) Legal Language
Lengthy CTA negotiations are a common barrier to clinical trial start-up. Avoid significant delays in study initiation by working with the site legal department to develop standardized and consistent language relating to common essential agreement clauses such as subject injury, indemnification, payment terms, and insurance.
When negotiating a study contract, bear in mind that sponsors keep meticulous records of CTAs. A poorly negotiated CTA can generate reoccurring inefficiencies in future negotiations. If a past CTA negotiation is unsatisfactory and a site wishes to change the terms of future CTAs, the sponsor may require justifications for the requested changes.
Having CTA language ready prior to negotiation will create a smoother, more efficient CTA negotiation with the sponsor, and will ensure future negotiations do not come under unnecessary scrutiny from the sponsor.
If you would like to learn more about developing site efficiencies, contact us. GuideStar’s research team has years of experience with clinical trial operating procedures, compliance and communications.
GuideStar works with hospitals, health systems, academic medical centers and physician practices around the country to build and support clinical research programs. From helping organizations incorporate a clinical trial strategy to providing management guidance and support, our service delivery is based on operational and financial best practices to ensure optimal results for research programs.