Best Practices to Become a Preferred Site

Mirror, Mirror, on the wall, who’s the fairest site of all? It could be you! What is a preferred site? How can you increase your site’s visibility? How does one assess feasibility to determine if a study is a good fit for your site/sponsor? What can a site do to ensure a clinical trial is operational?  This workshop will explore best practices for FDA-compliant source and regulatory documentation and the tools that can help to get you there.  Most non-compliance noted through monitor visits, regulatory inspections, and audits stem from inadequate and inconsistent documentation at sites. Learn how to best prepare for a monitoring visit or site audit/inspection.  Learn techniques to better manage your regulatory files and prepare to answer sponsors, auditors, and inspectors regarding screening/enrollment numbers, subject withdrawal, informed consent, recruitment efforts, delegation of authority, protocol violations, and adverse events. Identify what is adequate source. What do I really need to file in my site master file, what are “extras” that will make my site preferred by sponsors? Evaluate how to best document PI oversight. Determine when to use a note-to-file and what constitutes an effective CAPA. Tips and tricks for managing the regulatory file will be provided through tools/worksheets/templates and interactive activities. Over 200 pages of templates and tool will be provided. 

• Recognize the importance of quality in clinical trials by identifying key areas for improved documentation and communication
• Identify key factors in site selection
•  Discuss the steps in evaluating a site from both the sponsor and site perspectives
• Implement best practices that will ensure successful completion of trials and preferred site status with sponsors
• Identify key areas for improved documentation and communication leading to better quality
• Manage documentation of recruitment efforts effectively
• Manage potential document management inconsistencies proactively

• CRCs
• Site Managers
• Investigators  
• Site Selection personnel  
• CRAs who wish to help develop sites
• Quality Personnel

The course will be led by one of the following instructors:

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

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Day 1: 8:30 a.m. – 5:00 p.m.

• Recap, Quality in Clinical Trials: Key factors determining quality of sites
• Trends Site/Study Selection: Questions to ask and tools to impress
• Study Documentation: Best practices for maintaining and archiving
• FDA Monitoring/Audits/Inspections: Best practices to be inspection ready
• Tips on promoting your site

• Site Assessment/Study Feasibility Exercise
• Create use of a site recruitment plan
• Review of Warning Letters and creation of appropriate CAPAs
• Review of tools and templates

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-17-002-L01-P. Released: 2/17.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.