
* INFORMATION ABOUT FEES ADDRESSED TO PROMOTERS OF CLINICAL RESEARCH WITH MEDICINES AND CONTRACT RESEARCH ORGANIZATIONS (CRO). FEE EXEMPTION APPLICATION MODEL (odt format y and word format).
- NORMS OF GOOD CLINICAL PRACTICE (CPMP/ICH/135/95).
- HELSINKI DECLARATION.
- CALENDAR OF CCEIBA MEETINGS.
- INSTRUCTIONS TO REQUEST THE REFUND OF FEES UNDUELY PAID IN CASE OF EVALUATION OF CLINICAL TRIALS OR OTHER STUDIES (MODEL 046).
- INSTRUCTIONS OF THE ANDALUSIAN CENTER OF PHARMACOVIGILANCE FOR NOTIFICATION OF SERIOUS AND UNEXPECTED ADVERSE REACTIONS AND SAFETY REPORTS IN CLINICAL TRIALS CARRIED OUT IN ANDALUSIA.
- Read the explanation about the other documents here first.
- General information about TFG/TFM.
- Ethical Assessment Request Form.
- Confidentiality statement.
- Authorization of the Center where the field work is carried out.
- Instructions to include the project in the Andalusian Biomedical Research Ethics Portal (PEIBA).
- Instrucciones Instructions for Study Evaluation Post-authorization Observations.
- Application model (Annex 1) for Observational Studies of Prospective Follow-up (EPA-SP).
- Resolution approving the contract model.
- Unique contract model for Post-authorization Studies with medicines.
- Economic Memory Model for Post-authorization Studies with Medications.
- Breakdown of payment for visits.
- Instructions for completing the payment of Fees.
- Order SAS/3470/2009, of December 16, which publishes the guidelines on post-authorization observational studies for medicinal products for human use.
- SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES (AEMPS).
- ROYAL DECREE 1090/2015, of December 4, which regulates Clinical Trials with medicines, the Ethics Committees for Research with medicines and the Spanish Registry of Clinical Studies.
- Unique Model of Economic Contract for Clinical Trials.
- Resolution approving the Contract model.
- Breakdown of payments per visit.
- Economic Report Model for Clinical Trials.
- SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES (AEMPS).
- BIOBANKS: needs from the perspective of pediatric research of 2012.
- CCEIBA ANNUAL ACTIVITY REPORT. YEAR 2016.
- CCEIBA ANNUAL ACTIVITY REPORT. YEAR 2017.
- REPORT OF ACTIVITIES OF THE RESEARCH ETHICS COMMITTEES OF ANDALUSIA. PERIOD 2010-2015.
- REPORT OF ACTIVITIES OF THE RESEARCH ETHICS COMMITTEES OF ANDALUSIA. YEAR 2018.
- CONTACT POINTS OF THE BIOMEDICAL RESEARCH ETHICS COMMITTEES OF ANDALUSIA.