The MRCT Center received endorsement to become an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspection.
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
Developing an ethical framework and toolkit for addressing post-trial responsibilities related to access to investigational product, access to medical care, and access to infrastructure.
Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture and to returning individual results.
The MRCT Center previously developed guidelines for the return of aggregate results to research study participants; this project will focus on returning individual results to study participants.
Improving regulatory capacity to provide a unified standard for conducting clinical trials.
The MRCT Center held a 3-day training workshop on International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6(R2) at Harvard Faculty Club last month.
The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants.
The Joint Task Force (JTF) for Clinical Trial Competency has updated and released its Core Competency Framework Version 2.0 for use by clinical research professionals and staff worldwide.
This Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) training program on Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) is a 3 1/2-day workshop — April 10-13, 2018 — hosted by the MRCT Center. It is specifically designed for regulators with responsibility for multi-regional clinical trials, drug review and approval.