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Study and Site Management 

The strength of the Therapeutics Development Network Coordinating Center (TDNCC) lies in our unparalleled experience in setting up and managing CF studies and our intimate knowledge of the CF research community.

From study design to study materials development, from site selection to site startup, we can provide the guidance, feedback and tools that will enable your study to be successful.

Clinical Project Oversight 

Experienced study managers oversee each clinical study and serve as the single point of contact for sponsors and lead investigators. Services include:

  • Management of study teams, including oversight of site monitors 
  • Maintenance of project timelines 
  • Study status and metrics tracking 
  • Vendor oversight

Site Selection 

Leveraging TDNCC resources and insights can help sponsors streamline the process of site selection and help ensure the most appropriate sites are selected for each study. Here are some of the ways we can help:

  • Identification of interested sites 
  • Development and collection of site feasibility questionnaires 
  • Pre-study evaluations and/or qualification visits 
  • Investigator selection

Study Start-Up 

The TDNCC has developed a set of standard systems, procedures and document templates that are custom-tailored for CF studies and frequently used by staff at TDN study sites. Utilizing these familiar tools increases efficiency while maintaining quality and consistency. Services include:

  • Preparation of site startup materials, such as template consent forms, subject diaries and subject instructions 
  • Development of study materials, such as study manuals, laboratory manuals, and source documents 
  • Development of study-specific procedures 
  • Development of study plans such as for communication and site monitoring 
  • Development and maintenance of study specific websites

Site Startup and Training 

TDNCC study managers and site monitors have established strong and consistent working relationships with CF clinical research teams across the country. This mutual understanding enables all parties to interact more effectively right from the beginning. Site startup and training services include:

  • Review of site-customized consent documents and assistance with site Institutional Review Board (IRB) submissions 
  • Collection of essential documents required for site activation 
  • Planning and conduct of investigator’s meetings, webinars, site initiation visits and other study-related training 
  • Negotiation and management of site budgets and subcontracts

Site Management and Monitoring 

In addition to our working relationships with CF study site personnel, we are knowledgeable about the unique aspects of CF studies, including specialized procedures and specimens. This combined expertise makes us extremely effective at managing and monitoring CF study sites. Services include:

  • Overall site management 
  • Interim monitoring and closeout visits 
  • Essential document collection and maintenance 
  • Study drug management and tracking 
  • Study supply management and tracking 
  • Laboratory specimen tracking 
  • Data listing reviews for interim or final reports

Specialized Study Implementation Support 

If you already have a clinical operations team in place to implement your study, the TDNCC can still help by providing CF expertise and insights into the CF community. Below are some examples of how we have supported the implementation of such studies:

  • Training of site monitors new to CF 
  • Assistance with developing CF-specific aspects of study documents 
  • Review of draft documents to identify any CF-specific logistical issues 
  • Performance of initial site assessments or provision of advice on site selection 
  • Participation in investigator’s meetings 
  • Facilitating interactions between sponsor or contract research organization (CRO) and clinical sites, National Resource Centers or other vendors

Related Information 

Additional services offered through the TDN Coordinating Center include:

Contact Us 

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Updated 2/12/13

The Cystic Fibrosis Foundation is an accredited charity of the Better Business Bureau.