| Title: |
Clinical intervention studies and implementation research |
| Keywords: |
Research
Planning and programming
Ethics
|
| Country: |
Spain
|
| Institution: |
Spain - Barcelona Institute for Global Health - University of Barcelona
|
| Course coordinator: |
Raquel Gonzalez
|
| Date start: |
2026-03-16 |
| Date end: |
2026-03-26 |
| About duration and dates: |
● 8 full days + 1 additional day for pre-readings made available 2 weeks prior to the course commencement ● Application deadline: 2 weeks prior to first presence course day |
| Classification: |
advanced optional
|
| Mode of delivery: |
Face to face
|
Course location:
Barcelona Institute for Global Health – University of Barcelona
School of Medicine and Health Sciences
Campus Clínic August Pi i Sunyer
Casanova, 143
08036 Barcelona |
|
| ECTS credit points: |
3 ECTS credits
|
SIT:
75 hours SIT
● Contact hours face-to-face: 30 h (including 2h exam)
● Self-study hours (reading and preparing for in-class exercises and activities): 45 h |
|
| Language: |
English
|
Description:
At the end of the course, students should be able to:
1. Describe the basic concepts of clinical intervention studies and the different types of study design
2. Explain the key steps for designing and implementing clinical trials
3. Conduct research according to the principles of good clinical practices
4. Discuss the ethical aspects and safety monitoring to take into account in clinical research and trials
5. Describe and discuss the key characteristics of implementation research and the main designs used in impact evaluation |
|
Assessment Procedures:
Students in the course will be evaluated individually using a mixed multiple-choice and open-ended questions written examination (25 questions) at the end of the course. Exam length: 120 min
Please note that per the University of Barcelona grades must be assigned on the 0 - 10 scale (to one decimal point), with a minimum passing mark of 5,0
Resit: A similar mixed multiple-choice and open-ended questions written examination (25 questions, 120 minutes) will be used as resit for students who will not reach a minimum score of 5/10 in the first evaluation. It will take place approximately one month after the results of the first evaluation have been published. |
|
Content:
First week:
1. Concepts of clinical intervention studies: types of study design, randomization, blinding, ethical aspects, efficacy vs effectiveness, etc. (2h)
2. Steps in designing a randomized clinical trial (RCT) (2h)
3. Clinical trials: ethics (with a focus in LICs) (2h)
4. Clinical trials: Good Clinical Practices (GCP) (2h)
5. Clinical trials: assessment of safety endpoints and monitoring of safety (2h)
6. Clinical trials: sample size calculation and statistical methods (2h)
7. Clinical trials: reporting- how to write, and critique, a clinical trial report (2h)
8. Cluster Randomized and stepped-wedge trials( 2h)
Second week:
9. Development of a clinical trial protocol (4h)
10. Implementation research: definition, frameworks and examples (2h)
11. Implementation research: methods (2h)
12. Fundamentals of quasi-experimental designs and impact evaluation (2h)
13. Practical experience: design of implementation research (2h)
14. Exam (2h) |
|
Methods:
Face-to-face lecture-presentations including theory (50%), in class group work and individual exercises and real examples of clinical interventions studies and implementation research (50%).
Students will be encouraged by the instructors to have an active participation and involvement in discussions in class.
Students must read the key bibliography in advance to the classroom sessions to take the most out of the session. |
|
Prerequisites:
Students should have taken an introductory Epidemiology course (on the level of tropEd core course) to enrol in this course.
tropEd candidates must accredit an English language level TOEFL test 550 or 213 computer-based or 79/80 internet-based or IELTS band 6.0 or equivalent. |
|
Attendance:
Minimum of 10 students. Maximum of 35 students. No limitations for tropEd students.
We will confirm if the course takes place at least 4 weeks in advance. |
|
Selection:
For tropEd students: First come, first served principle. |
|
Fees:
570 € + University taxes (90 Euro approx.) |
|
Scholarships:
Not available |
|
tropEd accreditation:
Accredited in Amsterdam, Sept 2025. This accreditation is valid until Sept 2030 |
|
| Email Address: |
raquel.gonzalez@isglobal.org |
| Date Of Record Creation: |
2025-10-24 10:14:47 (W3C-DTF) |
| Date Of Record Release: |
2025-10-24 10:35:56 (W3C-DTF) |
| Date Record Checked: |
2025-10-24 (W3C-DTF) |
| Date Last Modified: |
2025-10-24 10:35:56 (W3C-DTF) |
