PPT-New Requirements for VA ORD Investigators:

Implementation of Data Management and Access Plans Summary of New Requirements for VA ORD Investigators Implementation of Data Management and Access Plan Effective January 1 2016 VA scientists submitting applications for ORD funding will be required to include a Data Management and Access Plan . fdagovScienceResearchSpecialTopicsRunningClinicalTrialsGuidancesInformationSh eetsandNoticesdefaulthtm US Department of Health and Human Services Food and Drug Administration June 2010 Procedural brPage 2br Contains Nonbinding Recommendations Informa National Institute of General Medical Sciences. NIH and . New and Early Stage Investigators. Let’s review… the first steps in developing a competitive application. Get to know the . NIH Program . Faculty Advisor or Principal Investigator Supervision versus Student Investigator or Study Coordinator . Responsibilities. Gwenn Snow, MS, RD, CIP. IRB Program Manager. Office of Human Research Protection. Mary Kirker. Chief Grants Management Officer . National Institute of Allergy and Infectious Diseases . 2013 NIH Regional Seminar. International Collaboration. Slide courtesy of Stephano Bertuzzi. Dr. Francis Collins. Sponsor Responsibilities . Based on ICH . E6. GCP Guidance (Section. 5). Purpose:. To . provide an overview of Sponsor Responsibilities . to study sites. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site . Spouse Investigation Services. OUR RATES – RATHER COMPETITIVE WE THINK… UNCOMPLICATED WITH NO HIDDEN EXTRAS. Price includes . two investigators . plus tracker devices and photo evidence on request. All prices can be tweaked!. Mary Kirker. Chief Grants Management Officer . National Institute of Allergy and Infectious Diseases . 2013 NIH Regional Seminar. International Collaboration. Slide courtesy of Stephano Bertuzzi. Dr. Francis Collins. Donna Sullivan. Chief, Branch A, Grants Management Program. National Institute of Allergy and Infectious Diseases, National Institutes of Health. 2015 NIH Regional Seminar. International Collaboration. Background. Monday. , September 17, . 1984: 8 year old, Vicki Lynn . Hoskinson. left home to mail a birthday . card to her aunt . . This . was the first time Debbie Carlson had allowed . her to go out on her own. of California. Hosted by 1. st. Vice President. J. Corey Friedman. Webinars are the 3. rd. Thursday . everyother. month, minimum.. Keep it Legal. If you think you’re doing your client a favor you might be getting both of you in trouble.. New Requirements for VA ORD Investigators: Implementation of Data Management and Access Plans Summary of New Requirements for VA ORD Investigators: Implementation of Data Management and Access Plan NIH and . New and Early Stage Investigators. Let’s review… the first steps in developing a competitive application. Get to know the . NIH Program . Director for your scientific area. Contact them about your research ideas . Investigator of Record – Definition. “The individual at the CRS responsible for ensuring that a clinical trial is conducted in accordance with the protocol, applicable U.S. federal regulations, in-country regulations and any provisions imposed by the reviewing IRB/EC/other regulatory entity. This person is the signatory for the Form FDA 1572 for studies conducted under an IND or the DAIDS Investigator of Record Form for non-IND studies.” (from DAIDS Protocol Registration Manual, p.8). Jim McCarthy; Rutz. , . Erich; . W. ade Shrader; . E. rich Rutz; . Tom . Novacheck; . Kerr . Graham; . Davids, Jon R. .; . Kay, . Robert; Tim Theologis; Unni Narayanan; Anja . Van . Campenhout. ; Laura Brower; Paul Gross.