Methodological Support Services

Methodological Support Services

INiBICA outsources a methodological and statistical support service that provides researches with an interdisciplinary team of biostatisticians, biologists, mathematicians and physicists with extensive knowledge and experience in advanced statistical advice at all stages of biomedical studies and researches:

  • Optimal experimental design (sample size estimation, etc.).
  • Database review and cleaning.
  • Processing and analysis of data using the most appropriate statistical methodology to address each specific goal.
  • Preparation of scientific-technical reports.
  • Support in interpreting the results obtained.

Moreover, this methodological advisory service supports INiBICA's researchers in improving the competitiveness of their reports on R&D&I projects to be presented in regional and national calls. It specializes in the review of specific sections (methodology, design and statistical analysis), and also offers suggestions of form and structure in other sections (summary, equipment, background, bibliography, hypotheses, objectives and material and methods).

Additionally, they review protocols and research articles, particularly in the area of methodology and statistical analysis; and provide feedback to journal editors and reviewers on all statistical aspects of the work carried out.

PROTOCOL

Research studies or statistical consultations

If researchers are interested in receiving support from the methodological advisory service, the following steps must be taken:

1. Inform in advance your manager about the need for the service: gabriela.fernandez@inibica.es; diana.regueiro@juntadeandalucia.es

2. Fill in the form.

This form consists of the following sections:

• Contact details of the principal investigator.

• Purpose of the study.

• Hypotheses to be considered and answered.

• Study variables involved in the issue to be solved.

• Details of what is requested.

3. Send the form and all documentation you might consider appropriate (database, protocol, reference articles, etc.) to INiBICA management staff, who will forward the request to the person responsible for the methodological advisory service.

4. The methodological advisory service will contact the principal investigator to proceed with the work or to agree on estimated time frame for initiation and completion.

5. Throughout the development of the study, communication may be established between the investigator and the methodological advisory service team, in order to solve doubts and determine the work that needs to be done. INiBICA's management staff must be CC'd in all communications in order to facilitate the monitoring and supervision of the work.

The standard deadlines for research works (report submission) are 3-4 weeks from the date of application. The deadline varies depending on INiBICA's priorities, the number of previous applications and active projects, and the level of complexity and scope of the work requested.

INiBICA's PRIORITIES

  1. Review of reports for imminent calls, especially projects from the Department of Health of the Junta de Andalucía and Instituto de Salud Carlos III (ISCIII).
  2. Response to editors and/or reviewers of scientific publications of works carried out by the methodological advisory service.
  3. Works that result in scientific publications and/or doctoral theses.
  4. Studies to be presented in congresses.

Other types of requests should be evaluated and prioritized according to the number of requests and projects in progress.

REVIEW OF R&D&I REPORTS

For each call, INiBICA will inform investigators about the deadlines for online submission of their projects. It will also indicate the deadlines in order to request the methodological and statistical advisory service.

The investigator(s) must send the report in a format appropriate to each call, as complete as possible. Submitting this report long in advance of the deadline will allow to perform a more exhaustive review of the report and a more detailed assessment of the project to be submitted. Moreover, it will allow receiving guidance in order to address certain statistical needs that might cause restrictions.

Reports will be reviewed on a "first come, first served" basis, taking into account the date of receipt of the application and documentation.

DATA PROTECTION AND CONFIDENTIALITY

All information and data provided to the statistical review service are subject to total confidentiality for an indefinite period of time, as defined in the contract in force between INiBICA and the statistical review service.

Data protection regulations will be strictly followed. Therefore, any document or database received containing sensitive data (patients' names, etc.) will be immediately deleted (email, attachments and copies). The investigator will need to send again all documents and databases once the confidential information has been deleted.