Get Developing A Clinical Research Protocol - University Of Hawaii At ... - Hawaii

Completing the Developing A Clinical Research Protocol form is essential for researchers intending to submit their study proposals to the University of Hawaii's Biomedical Institutional Review Board. This guide provides a clear, step-by-step process to ensure that all necessary information is accurately filled out and submitted.

Follow the steps to successfully fill out your clinical research protocol form.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Begin by filling in the protocol title, version number, and date. Ensure the title reflects the focus of your study clearly.
3. Provide thorough information regarding the investigator and any co-investigators, including names, affiliations, and contact information.
4. List the performance sites where the research will occur. Include addresses and details of all clinical labs involved.
5. Outline the aims and objectives of your study, making sure to include both broad objectives and specific hypotheses.
6. Compose the background section, summarizing the significance of the research, relevant literature, and any existing knowledge gaps your study aims to address.
7. Describe your research design, methods, and procedures explicitly. Be sure to cover all aspects of the study including participant criteria and data collection methods.
8. Detail the statistical methods and analysis plan, including sample size determination and the metrics for assessing outcomes.
9. Address human subjects protection, outlining your recruitment strategies, procedures, and how you will ensure the confidentiality and welfare of participants.
10. Supply complete references for all cited materials and include any appendices that support your protocol, such as consent forms and questionnaires.
11. Once completed, review the entire document for clarity and consistency, save your changes, and prepare to submit the form for IRB review.

Start filling out your clinical research protocol online today to ensure a successful submission.