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Minimum general requirements for the submission of applications or communications

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  • The documents should be clearly and legibly written.
  • Before starting any procedure, minutely review if the information entered in the form is updated and correct, and if the procedure to be started complies with the requirements indicated in the Clinical Trials Regulations. This will prevent delays and annulments, and will allow offering a prompt and efficient service.
  • All documents should be numbered from back to front and submitted to the National Institute of Health in a ring binder, ordered pursuant to the stipulations set forth, indicating each document name by means of markers.
  • Each procedure related to Clinical Trials should be submitted in its corresponding file and separately in the INS’ Documentary Procedures Office.