- Royal Decree 957/2020, of 3 November, which regulates observational studies with medicines for human use.
- Organic Law 3/2018 of 5 December, on the Protection of Personal Data and the guarantee of digital rights (LOPD-GDD).
- Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016.
- Royal Decree 1090/2015, of December 4, regulating clinical trials with medicines [Spanish].
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials of medicinal products for human use, and repealing Directive 2001/20 / EC [Spanish].
- Order ECC / 1404/2013, of 28 June, amending the annex to RD 1716/2011, of 18 November [Spanish]. It refers to an amendment to the Biobanks Act, by which collections cannot be declared by an institution but by an individual.
- Royal Decree 1716/2011, of November 18, which establishes the basic requirements for authorization and operation of biobanks for the purposes of biomedical research and the treatment of biological samples of human origin, and regulates the operation and organization of the National Register of Biobanks for biomedical research [Spanish].
- Law 14/2007 on Biomedical Research [Spanish].
- Order SCO / 256/2007 establishing the principles and detailed guidelines of good clinical practice and the requirements for authorizing the manufacture or import of medicinal products for research into human use [Spanish].
- Royal Decree 1344/2007 regulating the pharmacovigilance of medicines for human use [Spanish].
- Decree 406/2006 regulating the requirements and accreditation procedure for research ethics committees.
- Law 29/2006 of guarantees and rational use of medicines and health products [Spanish].
- Royal Decree 1201/2005, of October 10, on protection of animals used for experimentation and other scientific purposes [Spanish].
- Circular 7/2004. Clinical research with health products [Spanish].
Drug Research Ethics Committee
- Presentation
- Requirements and documentation
- Legislation and ethical standards
- Contact
El Drug Research Ethics Committee (CEIm) del Parc Taulí is one of the most active nationally evaluating studies. Annually, the committee evaluates about 350 studies as CEI and about 60 studies as CEIm.
The CEIm of Parc Taulí was accredited for the first time on February 3, 1994, and subsequently renewed on April 1, 2008 and May 6, 2013.
In January 2018, this Committee was accredited by the Generalitat de Catalunya to act as a CEIm in accordance with the provisions of RD 1090/2015.
The CEIm of Parc Taulí has adapted its own Standardized Work Procedures to new regulations for clinical trials with medicines and healthcare products (RD 1090/2015 of December 4).
The Committee is accredited by The Office For Human Resarch Protections of the United States Department of Health and Human Services. Federalwide Assurance (FWA), FWA00025624 through 31/05/2022, which includes:
- IRB00005089 for the Research Ethics Committee
- IORG0004295 by the Consorci Corporació Sanitària Parc Taulí.
| Health centers | Non-health centers | |
|---|---|---|
| From Parc Taulí |
Hospital of Sabadell Albada Social and Health Center Mental Health Center Cap Can Rull, Primary Care Attention to the Dependency |
Sabadell Senior Citizens Residence |
| External to the Parc Taulí |
Trauma Health Sabadell Male Infertility Center Barcelona |
Private Foundation Pro People with Intellectual Disability Catalonia |
Presidency
- Miquel Àngel I followed Palmer. Doctor, Oncology. Member of the Research Committee.
Vice-presidency
- Marcela Manríquez Tapia. Clinical pharmacology.
Secretary
- Coloma Moreno Quiroga. doctor Parc Taulí Foundation.
Members
- Santiago Alfonso Zamora. Non-health member. Patient Representative.
- Joan Calvet Fontova. Doctor, Rheumatology.
- Albert Cano Paolomares. Doctor, Endocrinology and Nutrition.
- Candelaria by Haro López. Doctor, Intensive Care Medicine.
- Sole Fernández Gonzalo. psychologist
- Ivan Flores Sanz. Member of the Customer Service.
- Yolanda Garcia Garcia. Doctor, Oncology.
- Pilar Garcia Iglesias. Doctor, Digestive.
- Jose Ibeas Lopez. Doctor, Nephrology and Dialysis.
- Mireia Massot Mesquida. Primary Pharmacy. Member outside the institution.
- Montserrat Pamias Massana. Doctor, Mental Health.
- Susana Redondo Capafons. Hospital Pharmacy.
- Guillem Reig Loncán. jurist Expert in data protection.
- Ester Risco Vilarasau. Nurse.
- Roger Rojas Sayol. doctor Orthopedic Surgery and Traumatology
- Juan Pablo Trujillo Quintero. Doctor, Pediatrics.
- Montserrat Vinyallonga Flores. Non-health member. Patient Representative.
| 2023 calendar | |
|---|---|
| December (2022) | I 13 27 |
| January | I 10 31 |
| Febrer | I 14 28 |
| Març | I 14 28 |
| April | I 11 25 |
| Maig | I 16 30 |
| Juny | I 13 27 |
| July | I 11 25 |
| August | Consult secretary |
| September | I 12 26 |
| October | I 17 31 |
| November | I 14 28 |
| Desembre | 12 and consult secretariat |
- Drug clinical trials
- Clinical trials without drugs
- Observational studies
- Management of contracts
- Suitability of the center [Requirements] [Model]
- Standards of good clinical practice (European Commission. CPMP / ICH / 135/95) [Spanish] [English].
- Convention on Human Rights and Biomedicine (Oviedo Convention, 1997) [Spanish].
- Helsinki Declaration of the World Medical Association. Ethical principles for medical research in humans (2008) [Spanish]
- International ethical guidelines for biomedical research in humans (Council of International Organizations of Medical Sciences, CIOMS) [Spanish].
- International ethical guidelines for the ethical evaluation of epidemiological studies (Council of International Organizations of Medical Sciences, epidemiological CIOMS) [Spanish].
- English-Spanish translation manual of clinical trial protocols. Notebooks of the Dr. Antonio Esteve, number 23.
Drug Research Ethics Committee
Parc Taulí Research and Innovation Institute Foundation (I3PT)
Plaça de la Torre de l'Aigua, s/n
08208 Sabadell