- Hospital de Santo António
- Centro Materno-Infantil do Norte
- Centro de Genética Médica
Centro Hospitalar do Porto is a Public University Hospital of the Portuguese National Health Service that ensures each patient care that meet their needs, according to best in clinical practice and logical of clinical governance, promote an efficient use available resources, covering also the areas of research, teaching, prevention and continuity of care. The Hospital has a consortium with ICBAS, University of Porto, the Academic Clinical Center.
Contact person: Luísa Lobato, MD, PhD
E-mail: diretora.defi@chporto-min-saude.pt
Phone: +351 918 815 980
Center Website: www.chporto.pt
As a Clinical Research Center (CRC), CHP provides the clinical investigators the necessary infrastructure for the efficient conduct of high quality clinical research to perform clinical trials from all medical specialties.
Contact person: Luísa Lobato, MD, PhD
E-mail: diretora.defi@chporto-min-saude.pt
Phone: +351 918 815 980
Center Website: www.chporto.pt
As a Clinical Research Center (CRC), CHP provides the clinical investigators the necessary infrastructure for the efficient conduct of high quality clinical research to perform clinical trials from all medical specialties.
CHP has a Department of Education, Training and Research where is located the Research Coordination Office (RCO).
The Research coordination Office is the infrastructure specifically dedicated to clinical trials management, with exclusively personnel, to support clinical trials coordination, financial management and also regulatory affairs. This Office manages all clinical trials and grant funds, calculates additional support for investigator-initiated studies, and facilitates administrative interactions between CRC staff members (RCO) and the study teams in the hospital center. The major focus of this clinical research center is to conduct international clinical trials (academic and commercial) complying with ICH GCP (Good Clinical Practice Guidelines).
The Research coordination Office is the infrastructure specifically dedicated to clinical trials management, with exclusively personnel, to support clinical trials coordination, financial management and also regulatory affairs. This Office manages all clinical trials and grant funds, calculates additional support for investigator-initiated studies, and facilitates administrative interactions between CRC staff members (RCO) and the study teams in the hospital center. The major focus of this clinical research center is to conduct international clinical trials (academic and commercial) complying with ICH GCP (Good Clinical Practice Guidelines).
The Research coordination Office has a separate financial management department (from de Hospital Administration) with competences and experience needed to support the negotiation and submission of the clinical trials contracts in the hospital.
The Research Coordination Office (RCO) has dedicated offices and rooms for Clinical trials management.
Considered a site of excellence for amyloidosis clinical trials, CHP have a dedicated area, with specific equipment for chemistry lab as well as one bed in the Department of Neurosciences.
All the facilities for commercial clinical trials are common to care activities and all ensure equipment specifically allocated for clinical trials (when applicable).
Considered a site of excellence for amyloidosis clinical trials, CHP have a dedicated area, with specific equipment for chemistry lab as well as one bed in the Department of Neurosciences.
All the facilities for commercial clinical trials are common to care activities and all ensure equipment specifically allocated for clinical trials (when applicable).
Training: Team and clinical staff is trained on a regular basis: Physicians, Pharmacists, Study nurses.
Training recorded on: CV update and the Investigator Master Files updated.
Training providers: In CHP, at the Department of Education, Training and Research, there is the possibility of graduates in health areas or management areas carry a 3 month traineeship with the central coordination of clinical trials after curriculum selection and an interview.
Initially, the theoretical aspects of a clinical trial are taught.
The department provides a manual of good clinical practice. The trainee follows the central coordinator of clinical studies to practical application of the steps of implementing a study.
Topics include feasibility assessment, recruitment of subjects, budget, human resources, regulatory issues, adverse event reporting, informed consent, electronic medical records, data registry for internal use. The trainees perform an evaluation report at the end of the trainee.
Communication with scientific community: Mailing list
Training recorded on: CV update and the Investigator Master Files updated.
Training providers: In CHP, at the Department of Education, Training and Research, there is the possibility of graduates in health areas or management areas carry a 3 month traineeship with the central coordination of clinical trials after curriculum selection and an interview.
Initially, the theoretical aspects of a clinical trial are taught.
The department provides a manual of good clinical practice. The trainee follows the central coordinator of clinical studies to practical application of the steps of implementing a study.
Topics include feasibility assessment, recruitment of subjects, budget, human resources, regulatory issues, adverse event reporting, informed consent, electronic medical records, data registry for internal use. The trainees perform an evaluation report at the end of the trainee.
Communication with scientific community: Mailing list
No certification for the Clinical trial center/units, the procedures are supported by an Internal rule Manual. CHP is a hospital accredited by Caspe Healthcare Knowledge System (CHKS) in general.
- CENTRALIZED SUBMISSION
- DECENTRALIZED IMPLEMENTATION: SET-UP, CONDUCT, COMPLETION/ CLOSE-OUT
- FINANCIAL MANAGEMENT
- INVESTIGATIONAL MEDICINAL PRODUCT MANAGEMENT (Pharmacy department);
- MANAGEMENT OF BIOLOGICAL SAMPLES
- DECENTRALIZED IMPLEMENTATION: SET-UP, CONDUCT, COMPLETION/ CLOSE-OUT
- FINANCIAL MANAGEMENT
- INVESTIGATIONAL MEDICINAL PRODUCT MANAGEMENT (Pharmacy department);
- MANAGEMENT OF BIOLOGICAL SAMPLES
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