Spotlight: K Grant Writing

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/