SSPA ETHICS COMMITTEES NETWORK
RESEARCH ETHICS COMMITTEES
CEI OF CÁDIZ
DOCUMENTS AND INSTRUCTIONS
* 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).
GENERAL DOCUMENTS
- 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.
END OF DEGREE AND END OF MASTER'S PROJECTS (TFG/TFM)
- 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).
POST-AUTHORIZATION STUDIES FOR PROSPECTIVE DRUG MONITORING (EPA-SP)
- 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).
CLINICAL TRIALS WITH MEDICINES
- 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).
CLINICAL TRIALS WITHOUT MEDICATIONS
DOCUMENTS OF INTEREST
- 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.
WEB OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES. CLINICAL RESEARCH WITH MEDICINES FOR HUMAN USE
WEB OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES. Guide for the correct preparation of a model patient information sheet and informed consent (HIP/CI)
