Ethics Committee

The Research Ethics Committee (CEI) of the Mar del Plata Medical Research Center (CIM-MDP) has the mission of ensuring the safety of the subjects who participate in research studies, evaluating critically, objectively and in accordance with current ethical standards.

Members

President

Dr. Donadio, Martín
Neurologist
DNI 26057807
Does not belong to the Institution

Member:

Vera, Ma. Bruna Marcela
Magister Lawyer Health Economics and Administration of Health Organizations
DNI 22289325
Does not belong to the Institution

Secretary:

Alvarisqueta, Federico
Lawyer
DNI 31018614
Belongs to the Institution

Member:

Dr. Taborda, Jorge Bernardo
Pulmonologist
DNI 10050541
Belongs to the Institution

Member:

Castillo, Marcos Adrián
Physical Education Teacher
DNI 26346391
Does not belong to the Institution

Alternate:

Boyd, Patricio
Degree in political science
DNI 26953023
Does not belong to the Institution

Member:

Rodriguez Golpe, Daniela
Degree in Biological Sciences
DNI 31018412
Does not belong to the Institution

Alternate:

Dra. Testa, Gladys Alicia
Rheumatologist
DNI 11209807
Belongs to the Institution

Standard Operating Procedures

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.

Download POE version 2
year 2018

Recommendations and new responsibilities before COVID-19 version 4 of July 31, 2020
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