Disseminating templates for informed consent forms and data use agreement for broad data sharing purposes to use prospectively.
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories.
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.
Dec 21, 2017
MRCT Center 2017 Impact Report Released
On December 6, 2017, at the MRCT Center Annual Meeting, we released the MRCT Center 2017 Impact Report, Harmonizing the Clinical Trial Ecosystem.
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The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants.
Jan 23, 2018
MRCT Center Bioethics Collaborative: Enabling Informed Selection of Clinical Trials: Institution, Provider, and Participant Responsibilities
This meeting of the MRCT Center Bioethics Collaborative will explore the ethical considerations underscoring the challenge of informed selection of clinical trials. We will examine the responsibilities of various stakeholders within the clinical trial ecosystem, and we will discuss potential solutions.
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.