Investigator Training: A Certificate Program on Good Clinical Practice (GCP) and Diversity in Clinical Trials

This comprehensive two-day, in-person training program is offered free of charge and is designed to provide participants with essential knowledge on the conduct of clinical research, regulations, and compliance. The program will focus on key areas, including Good Clinical Practice (GCP), diversity in clinical research participation, and the integration of digital health technologies.

Event Details:

• Dates: April 25-26, 2025
• Location: Innovation Center, Puerto Rico Science, Technology & Research Trust (PRSTRT) 105 Carr. #21, Km. 0.8, Bo. Monacillo, San Juan, Puerto Rico
• Schedule: 8:30 a.m. – 5:00 p.m. each day

This training is presented by the Puerto Rico Consortium for Clinical Investigation (PRCCI), Inc., a 501(c)(3) nonprofit organization subsidiary of the PRSTRT. Established in April 2016, PRCCI strives to advance clinical research in Puerto Rico by fostering an innovative environment while enhancing the quality of life for the Puerto Rican population through cutting-edge clinical research.

Application and Selection:

This is a complimentary training, and participants will be selected based on a competitive application process. To apply, please complete the application form by March 31, 2025. Click here to fill out the form https://forms.office.com/r/yD4hqfwxyR

The selected participants will include professionals who are (or will be) qualified to assume the role of Investigator, responsible for the conduct of clinical research studies (including trials).

This training seeks to ensure that clinical research participants more accurately represent the population most likely to benefit from future healthcare advancements. By cultivating a clinical research workforce that mirrors the community it serves—particularly empowering the next generation of investigators in Puerto Rico—it aims to promote greater diversity and inclusivity in clinical trials.

Why Become a Clinical Research Investigator?

Benefits include professional development, the opportunity to positively impact patients, new opportunities for business development, peer recognition, and contributing to the advancement of global healthcare.

Special Recognition: This Investigator Training is part of the TransCelerate BioPharma Mutual Recognition Program for ICH E6 GCP Training. Upon successful completion of a post-training exam, participants will receive a certificate recognized by multiple TransCelerate BioPharma member sponsors, eliminating the need for retraining at the start of new studies across these sponsors.

Learning Objectives: By the end of the Investigator Training, participants will be able to:

1. Describe the key elements of clinical research, including applicable regulations.
2. Implement effective participant recruitment and retention strategies, with an emphasis on fostering diverse participant populations.
3. Discuss feasibility studies, contract and budget negotiations, and site readiness.
4. Understand Good Clinical Practice (GCP), the role of the Institutional Review Board (IRB), informed consent, and the responsibilities of sponsors and Principal Investigators.
5. Detect and monitor adverse events (AEs) and serious adverse events (SAEs), justifying causality and ensure timely reporting.
6. Safeguard privacy and confidentiality and handle biological samples properly.
7. Maintain investigational product accountability.
8. Prepare for clinical research-related visits, audits, and inspections.
9. Incorporate digital health technologies in clinical research.

Support: This program is supported by an independent medical educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.

For any inquiries, please contact Dr. Mitzy González Moyeno at mitzy.gonzalez@prcci.org or by phone at 787-360-6927.

To apply for the Investigator Training: A Certificate Program on Good Clinical Practice (GCP) and Diversity in Clinical Trials, fill out this form https://forms.office.com/r/yD4hqfwxyR

The application deadline is March 31, 2025.