Spotlight: Munn Center for Nursing Research

The Clinical Genetics Research Facility is a research core managed by the Center for Genomic Medicine. We are located at 185 Cambridge Street on the 2nd floor of the Simches Research Center. PI’s and research groups across the institution are welcome to use the space, which includes exam rooms, a sample prep lab with a centrifuge and a refrigerator/freezer space, a phlebotomy room, interview rooms, and an EKG. All of our services are available by the half hour. Start-up is quick and simple, and tours are available by appointment.

For inquiries, please contact us at mghcgmcgrf@mgb.org. We look forward to helping you!

Dear Users,

Kindly note the new fees for the DCR core services for FY 25, effective October 1, 2024, to September 30, 2025.

Please reach out to dcrccre@partners.org with any questions on this.

Participants will acquire a practical understanding of:

• FDA’s approach to trial design
• Statistical issues in the analysis of trial data
• Safety concerns in the development of medical products
• Understanding preclinical information relevant to medical product development
• Clinical investigator responsibilities

INTENDED AUDIENCE

This clinical investigator training course is intended for all stakeholders in the clinical trial enterprise, including industry, academia, and regulators (both domestic and foreign). The agenda is designed for:

• Clinical investigators
• Healthcare professionals (physicians, nurses, pharmacists, and other healthcare workers)
• Individuals involved in biomedical research and the development of drugs and biological products

TOPICS COVERED

• Study design and protocol development
• Biostatistics and data analysis
• Ethical considerations
• Safety considerations for clinical trials
• Data management and integrity
• Regulatory requirements and compliance
• Innovations in trial design and implementation

LEARNING OBJECTIVES

• Understand key considerations for the design of clinical trials
• Review statistical concepts relevant to the analysis and interpretation of clinical trial data
• Explain the responsibilities of clinical investigators in the conduct of clinical trials
• Understand FDA regulatory requirements and guidance related to the design and conduct of clinical trials

FDA RESOURCES

• FDA Guidances
• FDA Office of Scientific Investigations
• CDER SBIA Learn

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance, which can be used to support CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program applies to clinical research regulations, operations, management, or to the candidate’s clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact info@sbiaevents.com for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues SupportExternal Link Disclaimer
• Test your PC for use with Adobe ConnectExternal Link Disclaimer prior to the day of the event. Adobe, the Adobe logo, Acrobat, and Acrobat Connect are registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

Postdoctoral and faculty researchers: Request a consultation and receive free guidance on biostatistical topics related to clinical study design. Consultations offered include IRB and grant submission/resubmission, protocol review, feasibility, analysis planning and advice, and manuscript reviewer response.

https://catalyst.harvard.edu/biostatistics/consultations/

Applications due: January 20th, 2025, 5:00pm EST

The Center for Precision Psychiatry (CPP) is committed to fostering the careers of early career investigators in the emerging area of precision psychiatry. Integrating research, clinical implementation, education and training, the Center is committed to driving innovation to implementation and making discoveries that can be translated to clinical care.

The Tommy Fuss Scholars Program in Precision Psychiatry will support innovative research efforts by early career investigators. Scholars will work with CPP faculty on projects aligned with the CPP mission and goals including therapeutics, big data analytics, precision treatment matching, mobile health technologies, genomics, neuroscience, and clinical trials. Recipients will receive $50,000 for one year, inclusive of indirect costs, to advance their research project. Funds can be used flexibly to support salary or research costs.

The Tommy Fuss Scholars Program is endowed by The Tommy Fuss Fund, a private foundation established by the Fuss family in memory of their son to promote medical research to further our understanding of mental illness and develop more effective means of diagnoses and treatment.

To learn more and apply visit the Center for Precision Psychiatry Career Opportunity Page.

Please direct any questions to mghctrprecisionpsych@mgh.harvard.edu

We are excited to announce that the Program in Clinical Effectiveness (PCE), a collaboration between Mass General Brigham and the Harvard T.H. Chan School of Public Health, is now accepting applications for the 2025 summer session! This 15-credit program, running from July 7 to August 15, 2025, is ideal for physician researchers, clinical researchers, fellows, faculty, NPs, and PAs seeking to enhance their quantitative and analytic skills in clinical research and healthcare administration.

While many students pursue this certificate as part of their MPH degree, it also serves as a stepping stone for those looking to further their research skills early in their careers or mid-career. Don’t miss this opportunity to elevate your expertise and make impactful contributions to the field.

Application Deadlines:

• Degree Students: December 1, 2024
• Non-Degree Students: February 15, 2025

For more information, please visit our website at https://www.hsph.harvard.edu/clinical-effectiveness/ or contact us at progclineffect@partners.org. We look forward to your application!