Good Clinical Practice (GCP) Guidelines (2026)
Objective:
The overall objective of the course is to train participants in clinical trials on the various aspects of GCP based on the ICH E6 (R3) document on Good Clinical Practice (International Conference on Harmonization). In addition, it aims to train and update researchers on current regulations in Spain and on the ethical aspects related to the conduct of clinical trials.
Specific objectives:
- To deepen understanding of the ethical and legal aspects of clinical research involving drugs and/or medical devices.
- Gain a deeper understanding of the Guidelines for Good Clinical Practice
- To deepen understanding of informed consent in healthcare research
- To deepen understanding of the responsibilities of the parties involved in clinical research.
- To deepen understanding of the role of the Institutional Review Board (IRB) in clinical research.
- To deepen understanding of the essential documentation for clinical trials.
- Reinforce the concepts of pharmacovigilance and applicable regulations in clinical trials.
- To develop the general principles of Good Clinical Practice in Advanced Therapies.
- Deepen understanding of clinical trial audits and inspections.
- Raise awareness of the importance of the Case Report Form in clinical trials.
Date:
The exam will be available from December 14 to 21, 2026, via the IBSAL platform.
Location:
Online. IBSAL Platform
Speakers:
- Ms. Carmen Arias De La Fuente.
Ph.D. in Molecular Biology. Head of the Clinical Trials Division at the IBSAL Management Unit.
- Ms. Esperanza López Franco.
Ph.D. in Molecular Microbiology and Genetics. Manager and CRA at the UICEC IBSAL/SCReN.
- Mr. Ricardo López Pérez.
Ph.D. in Biochemistry. Manager and CRA at the UICEC IBSAL/SCReN.
- Ms. Maria Concepcion Turrión Gómez.
Ph.D. in Pharmacy and Biochemistry. Technical Secretary of the CEIm for the Salamanca Health District.
- Mr. José V. Hernández Madrid.
Bachelor’s Degree in Pharmacy. Study Coordinator/Data Manager in the Clinical Trials Division at IBSAL.
- Ms. Cristina Lugones Sánchez.
Ph.D. in Nursing. Researcher at IBSAL and APISAL
- Ms. María Fátima Macho Sánchez-Simón.
Bachelor of Veterinary Medicine, Ph.D. in Neuroscience, Research Associate at the UICEC’s SCReN at IBSAL.
Program:
Open document: https://drive.google.com/file/d/12KmWoVesPUekAzsZ6cVEB_Wb9q-suzhE/view?usp=sharing
Registration:
The pre-registration deadline is Thursday, December 10, 2026. Please register individually through our website:
In order to successfully complete the course and receive the relevant certificate, it is necessary to complete 80% of the total program.
Please note that you will only be considered enrolled in the course once you receive the confirmation email, as there is a limit of 40 spots for Ibsal staff.
Method of selection:
Enrollment in the course will be carried out in strict order of enrollment (in courses with high demand, preference will be given to IBSAL personnel), according to the agreement of the IBSAL Training Commission.