As specified in section 6, documents shall be presented within the following time frames if they are to be reviewed in the appropriate meeting:

1. First meeting (second Tuesday of each month). To be received 11 days prior to the meeting:

  • Modifications to trials (Royal Decree 561/1993)
  • Observational studies
  • Clinical-research projects
  • Letters and reports
  • Adverse events

2. Second meeting (4th Tuesday of each month) from the 1st to the 5th of the month:

  • New clinical trials (Royal Decree 223/2004)
  • Single-center clinical trials
  • Clinical trials using medicinal products
  • Material and non-material modifications to clinical trials (Royal Decree 223/2004)

3. The following may be received in no particular time frame:

  • Studies approved by other hospitals

Whether acting as the reference committee or when involved alongside other committees, the decisions reached in the second meeting of a given month will be released on the third day of the following month. When acting as the reference committee, the FJD committee must review the reports issued by the other committees involved (between the 4th and 15th of the month) and prepare a ruling (in favor, pending clarification, or against). The committees involved, the applicant, and the Spanish Agency of Medicines and Medical Devices will be notified of this ruling on the 15th of the month.

If requested to do so, sponsors shall submit clarifications required by the reference committee from the 16th to the 20th of the month in which the ruling is reached or, at latest, by the 20th of the following month. Failure to reply within this period will be cause for a ruling against the proposal. The reference committee must verify that the reply is valid and inform the committees and sponsor involved in the process of the time frame for a decision to be reached.