Evaluation Requeriments for Observational studies:

 

Documention necessary to obtain the IEC/IRB assessment:

For the submission of proposals for observational studies, post-authorization or other studies to be approved by the IEC/IRB of IDIAPJGol, the following documents are required:

• Application to caary out the study.
• Commitment by the promoter and/or researcher that the protocol presented to the IEC/IRB is the latest version.
• Commitment of the main investigators.
• Complete investigation protocol.
• Patient information sheet and informed consent
• Economic report (if applicable)
• Classification document of the Spanish Agency of Medicines and Health Products.

 

Recommendations:

Informed Consent:

Informed consnet models must be included, you can use as a model the one established in Royal Decree 1090/2015, of December 4, for more specifications: a written consent model and/or oral consent model in front of witnesses.

 

Patient informartion sheet:

The information sheet must meet the following requirement:

• Clear and understandable language.
• What type of study and the interventions will be carried out
• Principal Investigator must be included.
• You must state where you can addres the subject to clarify any questions, and the telephone or contact centre in case of emergency.
• The voluntary nature of its inclusion in the study must be stated.

 

How to do it?

All original documetation must be sent in paper and on CD to the secretary of the IEC/IRB. The deadline for doing so is from 1 to 10 of each month.

 

Contact:

Secretary of IEC/IRB of IDIAPJGol:

Gran Via de les Corts Catalanes 591, àtic

93 482 46 04

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