The CCTS Monthly Forum was an interactive opportunity to talk about the most pressing challenges facing clinical trial research teams, and more specifically, principal investigators. Three clinical trial experts (credited below) provided critical information, along with a dose of encouragement:

1. Develop and follow protocol. A well-designed protocol provides the clinical research team instructions and directions that are strongly supported by scientific rational for conducting the study. Adherence to the protocol will provide consistent and reliable data, as well as guidance on conducting the protocol in a manner to protect human subjects. As always, patient safety is most important. From there, you must make sure the protocol is being communicated among the research team regularly.

Similarly, your statistical plan and budget development are crucial to the outcome of your study. Create the statistical plan in collaboration with a biostatistician or methodologist, and ensure that your budget includes every expense you’ll need covered. The CCTS Clinical Research Support Program (CRSP) hosts the experts who can identify costs that are frequently overlooked or under-budgeted in a clinical trial protocol.

2. Know the Rules and Regulations. Keep yourself abreast to the industry standards and regulatory changes that are relevant to your clinical trial and research. Be responsible, and remember, asking for forgiveness is not an option. Ensure you adhere to pertinent government agency and industry requirements. Below is a compilation of some regulatory and best practices resources:

        International Conference on Harmonization/Good Clinical Practice
        FDA Guidance Documents
        Institutional Review Board
        The Belmont Report
        Declaration of Helsinki

3. Mentorship is critical. (And teamwork is a game changer.) Did you know that 90% of doctors who participate in their first clinical study never participate in a second? The overwhelming nature of research calls for advice-giving, idea exchange and support. If you don’t know how to find mentors that will benefit your science, contact the CCTS for help in making those connections. The CCTS also offers Case Studies in Mentoring training to all investigators.

4. If you don’t know, ask. The tools you need are all around you. The Center for Clinical and Translational Science and CRSP is a responsive “front door” for clinical research support, and many other collaborators also exist, like the Office of Sponsored Programs, IRB and your own department or division lead.

These tips and resources are courtesy of these presenters:
     • Liz Busby, RN, BSN, OCN, CCRP, Director, Cancer Clinical Trials Office, O’Neal Comprehensive Cancer Center
     • Cynthia Joiner, PhD, MPH, RN, Associate Vice Chair and Assistant Professor, UAB Department of Medicine
     • Meredith Fitz-Gerald, RN, MSN, Director, CCTS Clinical Research Support Program, UAB School of Medicine

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