Protocol Requirements
Protocol Requirements
All RITHIM Application Forms within the Harmony system require submission of a protocol. A protocol is a detailed, written plan for a research project that outlines the research question, objectives, methodology, and procedures for conducting the project.
Protocols, at minimum, should clearly and concisely describe:
1. General Information
- Protocol title, protocol identification number, date, version number
- Name and address of the sponsor (and funder, if different)
- Principal investigator’s name and contact information, and the research site(s).
2. Background and Rationale
- A summary of existing knowledge and literature that establishes the problem, explains the project’s significance, and justifies why the research is needed.
3. Aims and Objectives
- A clear statement of the research question(s) and the specific, measurable goals the project aims to achieve, often divided into primary and secondary objectives.
4. Methodology
- A detailed description of the project design (e.g., randomized, observational), project population (inclusion/exclusion criteria), the interventions or procedures, and how data will be collected and measured.
5. Ethical Considerations
- How participants will be recruited, the informed consent process, measures for ensuring confidentiality and participant safety, and how data will be stored.
6. Data Management and Analysis
- The plan for data handling, quality control, and the specific statistical methods that will be used to analyze the data.
For those requiring assistance with protocol development, RITHIM recommends the following resources:
https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/protocol-template
https://www.research.chop.edu/services/protocol-templates