Ethics Committee

1. Cover letter signed by the principal investigator, detailing the documents sent with version and date

2. Protocol (No., Version and date)

3. Informed Consent Form (No., Version and date)

4. Information Sheet for the patient (No., Version and date)

5. Investigator's Manual (Edition number and date)

6. CV and Affidavit of the Principal Investigator

7. Material for the patient (No., Version and date)

8. Insurance policy and Certificate of coverage where the data of the Research Center and the Principal Investigator must appear

9. Model Contract with the sponsor

10. Letter of subrogation signed by the highest authority (if applicable)

11. Other relevant documentation

12. Final contract model

13. Approval of regulatory bodies ANMAT and CCIS

1. Cover letter signed by the principal investigator, detailing the documents sent with version and date

2. Protocol (No., Version and date)

3. Informed Consent Form (No., Version and date)

4. Information Sheet for the patient (No., Version and date)

5. Investigator's Manual (Edition number and date)

6. CV and Affidavit of the Principal Investigator

7. Material for the patient (No., Version and date)

8. Insurance policy and Certificate of coverage where the data of the Research Center and the Principal Investigator must appear

9. Model Contract with the sponsor

10. Letter of subrogation signed by the highest authority (if applicable)

11. Other relevant documentation

12. Final contract model

13. Approval of regulatory bodies ANMAT and CCIS

CENTER REGISTRATION:

1. Ministerial authorization for the operation of the Center as a Center for Medical Research.

2. Internment and transfer agreement (in case the institution does not have them).

3. Convention on pathogenic residues.

4. Institutional infrastructure sheet.

5. Letter of authorization from the highest authority of the center to carry out each study in particular.

6. Affidavit of the main Investigator, naming all the staff that will participate in the study

7. Letter of Surrogacy by the highest authority (in case of being a surrogate center).

REGISTRATION OF INVESTIGATOR:

1. Affidavit of the principal investigator of the study where you will participate

2. Curriculum Vitae

3. Photocopy of DNI

4. Registration and specialty certificate

5. Certificate of good clinical practices (GCP).

The Investigator has one month to inform the Committee of the following relevant dates of a clinical trial:

1. Center activation date

2. Date of first randomization

3. Enrollment closing date

4. Study closure date

ORDINARY MEETING:

The committee will meet twice a month in person on Thursdays and will hold another virtual meeting, and this provision may be altered if necessary.

EXTRAORDINARY MEETING:

The Chairman of the Committee shall have the power to call extraordinary meetings as a consequence of any matter of interest that requires immediate treatment. The day and time of the extraordinary meetings will preferably be set with the consensus of the members of the Committee.

• MINIMUM CONTENTS OF INFORMED CONSENT
• DIVERSION FORM
• CEI-CIMMDP INFORMED CONSENT
• MANDATORY PHRASES