The IRCCS ISMETT Ethics Committee is an independent body composed of professionals and experts from various other disciplinary fields.
Its role is to safeguard the rights, safety, and well-being of all individuals involved in clinical research and provide public assurance of these protections whenever required.The Ethics Committee develops guidelines and provides guidance on specific ethical issues related to IRCCS ISMETT’s activities that involve significant ethical implications.
Ethics Committee
OBSERVATIONAL STUDY CHECKLIST
Annex 1 (Letter of Intent for Authorization to Conduct an Observational Study Sponsored by ISMETT)
Annex 2A
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- (Declaration Confirming the Observational Nature of Studies Not Involving Medicinal Products) –
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- (with external Sponsor)
Annex 3 (Declaration of the Non-Commercial Nature of the Study)
Annex 4 (Statement of a conflict of interest )
Annex 5 (Statement of absence of conflict of interest)
Annex 6 (Synopsis)
INTERVENTIONAL STUDY CHECKLIST
Form for Collection, Preservation, and Future Use of Biological Samples
Annex 1 (DM 07/09/2017)
Annex 2 (Application for Compassionate Use of an Investigational Medicinal Product)
Annex 3 (Opinion on the Therapeutic Use of an Investigational Medicinal Product)
Annex 4 (Protocol for the Treatment Under Compassionate Use of an Investigational Medicinal Product)
Annex 5 (Declaration of Responsibility for the Compassionate Use of an Investigational Medicinal Product)
Annex 6 (Patient Informed Consent Form)
Annex 6.1 (Privacy Notice Pursuant to Article 13 of Regulation (EU) 2016/679 (GDPR))
Annex 7 (Letter for Patient’s General Practitioner)
Annex 8 (Clinical Report)
