Research Regulatory Services

The regulatory component of the Yale CTSA is housed in the YCCI’s Office of Research Services. The Office of Research Services (ORS) was a key innovation created at Yale with the funding of the initial CTSA award in 2006 to begin address deficiencies in the development and timely implementation of clinical and translational research. ORS is the infrastructure that supports Yale research providing “one stop shopping” of an array of research services for investigators while seeking to reduce or remove obstacles to clinical and translational research at Yale.

In 2009, the Mayo Clinic Center for Translational Science Activities (CTSA) Regulatory Affairs Office and its services transitioned into the new Mayo Clinic Office of Research Regulatory Support (ORRS), a centralized resource for all Mayo Clinic researchers in all programs and locations. The ORRS offers special expertise in Food and Drug Administration (FDA) regulations, including assistance for Investigational New Drug (IND) or Investigational Device Exemptions (IDE) applications, and serves as a liaison with other institutional resources such as Legal Contract Administration and the Institutional Review Board (IRB).

Purpose

Each institution’s research regulatory services and support models were shared between the project leaders Karen Hartman, Mayo Clinic’s Operations Manager for the Office of Research Regulatory Support and Stacey Scirocco, (now former) Operations Officer for Yale’s Office of Research Services, to identify opportunities to adopt novel services, processes, and/or tools for improvement of each other’s research regulatory support services.

Methods

The process included a detailed evaluation of the potential export/import for appropriateness, feasibility, and cost effectiveness as well as the development of an implementation strategy for execution. The collaborative sharing process identified useful lessons and challenged preliminary assumptions about the ease and utility of sharing effective practices across institutions.

  • Project team met to identify key components under each subproject
  • Devised telephone and face to face meeting structure to achieve goals
  • Mayo Clinic knowledge transferred to Yale on the following:
    • Centralized FDA audit coordination
    • Support for Study File Management
    • Exploration of Informatics Solutions
  • Yale knowledge transferred to Mayo Clinic on the following:
    • Research Assistant/Nursing Pool
    • Study Start Up Service
  • Information was exchanged via use the use of web conferences, emails, phone conferences and face-face meetings
  • After receiving info, team reviewed information, assessed the utility of having service at the home institution and ability to implement
    • If yes, set up for transfer 
    • If no, documented why and identified if other resources could be used instead
  • Receiving team also evaluated the offered service so that home Inst. could benefit from external feedback.  Feedback then incorporated as appropriate.

Results

Collaborative successes

Discussions around each other’s resources, tools, & processes had immediate value for both sides and many times led to ideas for improvement and suggestions for collaboration on future iterations of services, if not full swap and adoption. All of the tools, templates, quick reference guides for FDA audit preparedness and study files management that were shared to Yale have been utilized extensively as on-line tools for Yale staff and faculty, in session educational tools, for audit preparedness meetings (outside of the full service). Evaluation of these new tools at Yale has shown both were needed and appreciated by research staff as effective tools. While Yale does not have many annual FDA audits, the thinking is that this full service as developed by Mayo would be useful here due to the importance and significance of FDA audits and the positive effect this service could have on investigators, research teams and the overall research portfolio at Yale.

Yale additionally imported and utilized Mayo Clinic’s publications tracking and reporting system database and found that while there was a good amount of front end work involved to adopt and modify it for Yale in year 1, that front end work would significantly decline in subsequent years and the effect that it had on our ability to identify CTSA related publications for the annual report was extensive. While we cannot say for sure that we identified more publications over our previous manual system, we believe so, and know for sure its use was far more effective to request that investigators identify their publications from the mass list, and then track, organize, remind, and send to XML in this automated fashion. It also gave the administration and evaluation components back a significant amount of time (over the previous system) that was subsequently utilized for the more significant day to day operations of the Center and its research.  Finally, while Yale was not able to utilize Mayo’s IND/IDE tracking system database due the difficulty in modifying our existing IRB system to work with it properly, we later decided to implement an enterprise-wide clinical research management system and will be using the knowledge gained from Mayo’s system to inform our CTMS configuration for this purpose.      

Lessons learned

  • Site transferring tools/processes gains feedback and suggestions for improvement from receiving site
  • Informatics systems may not be easily transferred; it is ideal to conduct a thorough assessment prior to decision making
  • Receiving site needs to anticipate need for modifications specific to site use, including wording, intended audience, systems, etc
  • Institutional landscape over a 2 year project can change; this may affect changes to adoption plans
  • Consider cost to implement against cost avoided by receiving “ready Made” applications/systems- make sure it equates!
  • Other projects and information were identified for future sharing as the project progressed; Formalized relationship to continue.
  • Discussions resulted in discovery of previously unknown resources at one’s own institution