Get Spirit 2013 Checklist: Recommended Items To Address In A Clinical Trial Protocol And

The SPIRIT 2013 Checklist serves as a critical tool for researchers to ensure comprehensive and transparent reporting of clinical trials. This guide will provide you with clear, step-by-step instructions on how to effectively fill out the SPIRIT 2013 Checklist online.

Follow the steps to complete the SPIRIT 2013 Checklist successfully.

1. Click ‘Get Form’ button to obtain the form and open it in the editor or your preferred software application.
2. Fill in the administrative information section. Start by providing a descriptive title that identifies your study design, population, and interventions. If applicable, include a trial acronym.
3. In the trial registration section, input the trial identifier and the name of the registry. If not yet registered, indicate the intended registry.
4. Record the protocol version by noting the date and version identifier to ensure clarity in documentation.
5. Detail the funding sources by specifying financial, material, and other forms of support, ensuring all contributions are accurately represented.
6. List the roles and responsibilities by providing the names, affiliations, and roles of all protocol contributors.
7. Include the name and contact information of the trial sponsor to ensure proper communication.
8. Explain the role of study sponsors and funders regarding study design, data management, and report writing, emphasizing whether they will have ultimate authority over these activities.
9. Describe the composition and responsibilities of any coordinating center, steering committee, or data management team involved in overseeing the trial.
10. Formulate a clear research question with justification for conducting the trial, summarizing relevant studies on the benefits and harms of each intervention.
11. Outline specific objectives or hypotheses that guide your study.
12. Provide a detailed description of the trial design, including the type of trial and allocation ratio.
13. Detail the study setting, including descriptions of community clinics or academic hospitals involved and the countries where data will be sourced.
14. Define eligibility criteria for participants, including inclusion and exclusion parameters.
15. Clarify the interventions, detailing how they will be administered and any criteria for discontinuation or modification.
16. Specify the primary, secondary, and other outcomes, including measurement variables and methods for aggregation and assessment.
17. Draft a participant timeline that outlines the enrolment process and all relevant assessments and visits.
18. Estimate the sample size needed to meet study objectives and outline the assumptions that support your calculations.
19. Develop strategies for participant recruitment to meet the target sample size effectively.
20. Document the methods for allocation sequence generation and concealment to ensure randomization integrity in the trial.
21. Identify who will be blinded in the study and the unblinding procedures permissible during the trial.
22. Detail your plans for data collection methods, emphasizing the instruments used and strategies for data quality assurance.
23. Outline your data management strategies, including coding, security, entry, and storage to maintain integrity.
24. Establish statistical methods for analysis, ensuring clarity on primary and secondary outcomes.
25. Summarize the composition of the data monitoring committee and their oversight role, referencing independent procedures.
26. Provide a comprehensive plan for monitoring adverse events and implementing safety measures.
27. Describe your protocols for seeking ethics approval and communicating any protocol amendments to relevant parties.
28. Clarify how participants' personal information will be protected throughout the study.
29. Mention any competing interests of principal investigators, along with their provisions for post-trial care and access to data.
30. At the end of the process, ensure to save your changes, download a copy, and if necessary, print or share your completed checklist.

Start filling out the SPIRIT 2013 Checklist online today to ensure your clinical trial protocol is thorough and well-documented.