Good Clinical Practice (GCP) Certification
Tuesday, June 2, 2015
8:00AM – 11:30 AM
Wolstein Research Building Auditorium, Room 1413
8:00 – 10:00 AM- GCP and PI Responsibilities:
This session will include discussions of the relationships between laws, regulations, guidelines, and standard operating procedures. Key obligations of sponsors, monitors and investigators and their inter-relationships will be described. Investigators completing the program will receive a GCP certificate that can be provided to sponsors.
10:15 - 11:30 AM- Ethical Considerations, Informed Consent and Financial Disclosure:
This session will include a brief historical perspective of ethical considerations in conducting clinical research. The elements and process for obtaining informed consent from potential study participants will be discussed and well as financial disclosure.
Registration is online at: http://research.case.edu/Education/OnlineCalendar.cfm.
Department of Defense
The Department of Defense has announced the following new funding opportunities:
Department of the Army - USAMRAA
FY15 Peer Reviewed Medical Research Program (PRMRP)
Topic Areas: Acupuncture, Advanced Prosthetics, Burn Pit Exposure, Cardiovascular Health, Congenital Heart Disease, Focal Segmental Glomerulosclerosis, Healthcare-Acquired Infection Reduction, Hepatitis B, Hydrocephalus, Integrative Medicine, Metals Toxicology, Mitochondrial Disease, Nanomaterials for Bone Regeneration, Osteoarthritis, Pathogen-Inactivated Dried Plasma, Pulmonary Fibrosis, Psychotropic Medications. Respiratory Health (excludes lung cancer and mesothelioma), Sleep Disorders, Vascular Malformations, Women’s Heart Disease
DoD Peer Reviewed Medical Clinical Trial Award
DoD Peer Reviewed Medical Discovery Award
DoD Peer Reviewed Medical Focused Program Award
DoD Peer Reviewed Medical Investigator-Initiated Research Award
DoD Peer Reviewed Medical Technology/Therapeutic Development Award
NIH Posts Reminder of Its Policy on Application Compliance
The National Institutes of Health (NIH) recently released a notice to remind applicants, both investigators and grants office officials, that to be fair to all concerned the NIH needs to consistently apply standards for application compliance.
In part, the notice states that NIH may withdraw any application identified during the receipt, referral and review process that is not compliant with the instructions in the SF 424 (R&R) Application Guide, the Funding Opportunity Announcement, and relevant NIH Guide Notices.
Examples of reasons an application may be withdrawn for non-compliance include:
Read the full notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-095.html.
- inclusion of biosketchs that do not conform to the required format
- applications that do not conform to page limit requirements
- applications submitted as new but containing elements of a resubmission or renewal application
- applications submitted after 5 pm local time
Save the Date - Innovations in Research: Collaborations & Transformations
An Office for Human Research Protections (OHRP) Regional Conference
Wednesday, September 16, 2015
8:00 am - 6:00 pm
Global Center for Health Innovation
Case Western Reserve University and University Hospitals of Cleveland are pleased to announce that we are jointly hosting an OHRP Regional Conference this fall. Mark your calendar now, and keep an eye out for further updates and registration information coming soon!
Reminder: New NIH biosketch format effective May 25th, 2015
The new NIH Biosketch format will take effect for applications submitted on or after May 25, 2015. Key changes include:
- Extending the biosketch page limit to 5 pages
- Allowing PIs and researchers to include up to four references in their personal statement
- Allowing researchers to describe up to five of their most important contributions to science
- Allowing researchers to include a link that provides access to a full list of your published work
Kathy Blazar, interim director at our Cleveland Health Sciences Library, has prepared a power point presentation that can help you navigate the new format: http://www.case.edu/chsl/library/NIHBiosketch.pptx.
Additional points to consider:
If you have questions about the process, please contact Kathy Blazar at firstname.lastname@example.org.
- Investigators need to update their personal profile on eRA Commons
- Public access compliance need to be up to date
- All non-CWRU, most especially international, collaborators must also be compliant if they are named as key personnel.
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