The projects will be evaluated by an Evaluation Committee made up of 6 members:
- Fixed representatives:
- SEOM Section Representative Evaluation Results and Clinical Practice: Dr. Paula Jiménez Fonseca.
- SEOM Board Representatives: Dr. Javier Gallego Plazas, Dr. José Angel Arranz.
- PANDORA SEOM Developer: Dr. Alberto Carmona Bayonas.
- Representatives to select for each project:
- Specialists of the specific pathology, 1 or 2.
- SEOM, in appropriate cases, will request the cooperative groups to submit a name to participate in the Evaluation Committee.
- In the case of more than one group, they should be representatives of different groups.
- Coordinator: Dr. Javier Gallego (Representante de la Junta SEOM y Representante de la Sección SEOM de Evaluación de Resultados y Práctica Clínica).
- Time limit of membership of the Evaluation Committee, Coordination: 4 years.
Call for evaluation of projects for inclusion in the PANDORA registry:
- Biannual periodicity:
- Projects to approve: maximum of 5.
- Term de 2 meses para presentar proyectos (en la 1ª edición el plazo será de 3 meses).
- Calls: 2.
- March - April.
- September – october.
- Resolution:End of June and December.
- Only one request per IP (SEOM partner) is admissible.
- Principal Investigator implies being an interlocutor with SEOM, although several IPs may appear in your project.
- The IP that already has a project in PANDORA will not be able to request a new one until the recruitment of the previous study has been completed.
- Projects linked to a Cooperative Group, since they are not the objective of PANDORA-SEOM, will be considered, beyond the project itself, taking into account the capacity of the Cooperative Group compared to other applicants to develop the project outside of PANDORA-SEOM.
- Statistical analysis and administrative tasks must be provided - managed by the researcher.
Standards for evaluation of a project
- Confidentiality commitment.
- Independent initial evaluation by each of the members of the Evaluation Committee.
- Individualized report by each of the members within 15 days.
- The report will consist of:
- Decision: Rating from 1 to 5
- Approved with comments: scale 4-5
- Approved subject to minor changes: scale 3
- Rejected with arguments: scale 1-2
- Comments section: Comments are understood as the arguments for the decision.
- Although the final evaluation is in accordance with the above, the tool will facilitate the dispersed evaluation of the project to facilitate the work of the evaluators.
- Joint evaluation:
- Term of 30 days.
- In a joint meeting of evaluators (virtual).
- Approved: requires at least 3 passes (50%). In the case of only 3 approved, one of them must be from the coordinator.
- A report will be generated for the applicant through the PANDORA tool with decision and comments (minor changes, other comments, rejection arguments). It will not be sent until all the projects are evaluated and it will be done jointly when it has been determined by SEOM.
- If approved with minor changes, the applicant will be given a period of 30 days to respond to this proposal and incorporate the suggested changes into the project.
- If it does not comply with the stipulated, this project may be replaced by one of those that has been left in reserve.
- In case of rejection, if the applicant wants to resubmit the project, they must argue the changes based on the arguments for rejection and incorporate the new project with the highlighted changes.
- Final evaluation: It arises from the joint evaluation.
- Project approved.
- Approved conditional on minor changes.
- In reserve approved. In the event that those approved with change do not comply.
- Rejected with arguments.
- The final evaluation will be released on the same day for all projects.
- As a whole: 15 days for individual evaluators, 30 days for a joint one.
Criteria for evaluating projects
These are the criteria that the evaluators will consider in the individual evaluation and in sharing their evaluations.
- Number of patients.
- Epidemiological variables.
- Risk factor's.
- Prospective vs retrospective vs ambispective.
- Precision medicine.
- Translational character.
- Multidisciplinary character.
- Evaluation of health results.
- Inclusion of PROs.
- Project duration.
- Time limit for access to the tool to incorporate data.
- Consideration of simultaneity of similar projects in the same call.
- History of the research team (consolidated, emerging), cooperative group, independent...
- Originality of the objectives.
- Applicability of the results.
- Project feasibility.
Upon approval and notification by the Evaluation Committee, the IP must certify approval by CEIC of reference (unless it has been done in the initial presentation of the project) before the start of the project and within a period not exceeding 60 days.
If this is not the case, the authorization to use PANDORA will be withdrawn and its space will be assigned to the first project in the queue of favorably evaluated but awarded in that call.
In case of modifications of the project initially approved by the Evaluation Committee after its passage by CEIC:
- Evaluation by the Evaluation Committee of its relevance with respect to the previously evaluated within 30 days.
- If it is considered that it distorts what was initially approved, it could justify reconsideration by the Evaluation Committee.