Information for Research Teams
Professional Development
The Society of Clinical Research Associates (SOCRA)
A nonprofit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities.
Association of Clinical Research Professionals (ACRP)
The primary resource for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, and for those in hospital, academic medical centers, and physician office settings.
Public Responsibility in Medicine and Research (PRIM&R)
Educational and professional development programs that provide balanced, thorough, and accurate information on the full range of issues surrounding research involving human subjects and animals.
Training and Certifications
CITI Program
Offers content in many curricular areas, which can be combined into a package that fits the needs of each subscriber. CITI program courses include:
- Animal Care and Use (ACU)
- Biosafety and Biosecurity (BSS)
- Export Control (EC)
- Good Clinical Practice (GCP)
- Human Subjects Research (HSR)
- Information Privacy and Security (IPS)
- Responsible Conduct of Research (RCR)
Helpful Tools
- National Center for Complementary and Integrative Health (NCCIH) Toolbox
- Research Electronic Data Capture (REDCap)
- SMART IRB Reliance Request
- Harvard Catalyst Regulatory Foundations, Ethics, and Law Program
- MRCT presentation about Core Competencies
Core Competencies for the Clinical Research Professional
- Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials
- Clinical Research Program Course Catalog: Design and Conduct of Clinical Trials
- Encompasses care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial
- Regulatory Foundations, Ethics, and Law Program
- Research Ethics: “Conduct and Misconduct in Science”
- Clinical Research Program Course Catalog: Ethics and Clinical Research Protocols
- Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
- Integrating Effectiveness and Safety Outcomes in the Assessment of Treatments
- CITI Program
- Covers knowledge of how drugs are developed and regulated
- Investigational Drug and Devices
- FDA: How Drugs are Developed and Approved
- FDA: Information for Consumers
- Covers study management and GCP compliance; safety management (AE identification and reporting, post market surveillance, and PV) and handling of investigational product
- CITI Program
- Includes content required at the site level to run a study (financial and personnel aspects). Includes site and study operations (not encompassing regulatory/GCPs)
- Quality Management Overview and Tools
- Covers how data is acquired and managed during a clinical trial, including source data, data entry, queries, quality control and correction, and the concept of a locked database
- Data Management Guidance, Tools, and Resources
- Countway Library of Medicine: Classes, Tutorials and Seminars
- BWH Center for Clinical Investigation Courses and Training
- Data Acquisition, Management, Security, and Retention
- The principles and practice of leadership and professionalism in clinical research
- Leadership Strategies for the Researcher
- Encompasses all elements of communication within the site, between the site and sponsor, CRO and regulators. Understanding of teamwork skill necessary for conducting a clinical trial
- Effectively Communicating Research