Table 1.
Main sections and subsections in a complete research protocol
| Main investigator |
| Name |
| Address |
| Phone/fax |
| Number of involved centers (for multi-centric studies) |
| Indicate the reference center |
| Title of the study |
| Protocol ID (acronym) |
| Keywords (up to 7 specific keywords) |
| Rationale of the study (describe current scientific evidence in support of the research with a possible sub-section for the references) |
| Study design |
| Monocentric/multicentric |
| Perspective/retrospective |
| Controlled/uncontrolled |
| Open-label/single-blinded or double-blinded |
| Randomized/nonrandomized |
| n parallel branches/n overlapped branches |
| Experimental/observational |
| Others |
| Primary objective |
| Endpoints (main primary and secondary endpoints to be listed) |
| Expected results |
| Analyzed criteria |
| Main variables/endpoints of the primary analysis |
| Main variables/endpoints of the secondary analysis |
| Safety variables |
| Quality of life (if applicable) |
| Health economy (if applicable) |
| Visits and examinations |
| Therapeutic plan and goals |
| Visits/controls schedule (also with graphics) |
| Comparison to treatment products (if applicable) |
| Dose and dosage for the whole time period |
| Formulation and power of the studied drugs |
| Method of administration of the studied drugs |
| Informed consent |
| Study population |
| Short description of the main inclusion and exclusion criteria |
| Sample size |
| Estimate of the duration of the study |
| Best supposed perspective |
| Safety advisory |
| Classification needed |
| Requested funds |
| Additional features |
| On the main concept of the study |