Documentation FOR RESEARCHERS
SSPA NETWORK OF ETHICS COMMITTEES
RESEARCH ETHICS COMMITTEES
CEI DE CÁDIZ
DOCUMENTS AND INSTRUCTIONS
GENERAL DOCUMENTS
- GUIDELINES FOR GOOD CLINICAL PRACTICE (CPMP/ICH/135/95).
- HELSINKI DECLARATION.
- CCEIBA MEETING SCHEDULE.
- INSTRUCTIONS FOR REQUESTING A REFUND OF FEES PAID IN ERROR IN CONNECTION WITH THE EVALUATION OF CLINICAL TRIALS OR OTHER STUDIES (FORM 046).
- INSTRUCTIONS FROM THE ANDALUSIAN PHARMACOVIGILANCE CENTER FOR THE REPORTING OF SERIOUS AND UNEXPECTED ADVERSE REACTIONS AND SAFETY REPORTS IN CLINICAL TRIALS CONDUCTED IN ANDALUSIA.
BACHELOR'S AND MASTER'S THESES (TFG/TFM)
- Please read the explanation about the other documents here first.
- General Information About the TFG/TFM.
- Ethics Review Application Form.
- Privacy Statement.
- Authorization from the center where the fieldwork is conducted.
- Instructions for submitting the project to the Andalusian Biomedical Research Ethics Portal (PEIBA).
POST-APPROVAL PROSPECTIVE FOLLOW-UP STUDIES WITH MEDICATIONS (EPA-SP)
- Instructions for the Evaluation of Post-Approval Observational Studies.
- Application Form (Appendix 1) for Prospective Observational Follow-up Studies (EPA-SP).
- Resolution Approving the Model Contract.
- Standard Contract Template for Post-Approval Studies Involving Medications.
- Template for a Financial Report for Post-Approval Studies Involving Medications.
- Breakdown of payment by visits.
- Instructions for Making Fee Payments.
- SAS Order No. 3470/2009, dated December 16, publishing the guidelines on post-approval observational studies for medicinal products for human use.
- SPANISH AGENCY FOR MEDICINES AND HEALTHCARE PRODUCTS (AEMPS).
CLINICAL TRIALS OF DRUGS
- ROYAL DECREE 1090/2015, dated December 4, regulating clinical trials involving medicinal products, ethics committees for research involving medicinal products, and the Spanish Registry of Clinical Trials.
- Standard Contract Template for Clinical Trials.
- Resolution Approving the Model Contract.
- Breakdown of payments per visit.
- Template for a Financial Report for Clinical Trials.
- SPANISH AGENCY FOR MEDICINES AND HEALTHCARE PRODUCTS (AEMPS).
CLINICAL TRIALS WITHOUT MEDICATIONS
DOCUMENTS OF INTEREST
- BIOBANKS: Needs from the Perspective of Pediatric Research, 2012.
- CCEIBA ANNUAL ACTIVITY REPORT. YEAR 2016.
- CCEIBA ANNUAL ACTIVITY REPORT. YEAR 2017.
- REPORT ON THE ACTIVITIES OF THE RESEARCH ETHICS COMMITTEES OF ANDALUSIA. 2010–2015.
- REPORT ON THE ACTIVITIES OF THE RESEARCH ETHICS COMMITTEES OF ANDALUSIA. YEAR 2018.
- CONTACT INFORMATION FOR THE BIOMEDICAL RESEARCH ETHICS COMMITTEES IN ANDALUSIA.