 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
News & announcements from the RSPPFDA issues revised guidance document on protecting device and drug research subjectsThe FDA has issued a series of revised guidance documents to assist institutional review boards (IRBs) and clinical investigators in fulfilling their responsibilities to protect human subjects participating in clinical trials regulated by FDA. The five revised guidance documents are part of the agency's Information Sheet Guidance Initiative, through which the FDA plans to rescind information sheets that are obsolete, revise and reissue information sheet guidance that address current issues, and develop new guidance documents, as needed. The process of revising and reissuing all 40 existing documents may take several years to complete. Click here for the revised documents. Updated guidance documents are indicated by a date of 2006, highlighted in red. Attention physician investigators and clinical research coordinators working with investigational cardiac devices at Aurora St. Luke's Medical CenterThe mandatory research compliance training for year 3 of St. Luke's Settlement Agreement will begin later in the month of January 2007. You are encouraged to send your email address to Gail Buenger, Vice-President Project Management for Aurora Health Care at gail.buenger@aurora.org to help simplify the process. The plan this year is to conduct the training 100% online. Having your email address will speed up and simplify this process. You can also call Gail at 414-649-5599. Once again, individuals will have 30-days to complete the training. Anyone not complete by the due date will be suspended from cardiac device research privileges at St. Luke's until such time as the training is complete. Thank you. Aurora Health Care participates in the NCI CIRB InitiativeAurora Health Care is now participating in the National Cancer Institute's (NCI) Central IRB (CIRB) Initiative. As a participating organization, Aurora physicians who take part in Cooperative Group phase III adult oncology clinical trials may request to enroll their patients into CIRB-approved protocols. Please click here to learn more about the NCI CIRB Initiative. Mandatory IRB RegistrationOn July 6, 2004, the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) published a joint proposed rule in the Federal Register (v. 69 no. 128) regarding the mandatory registration of Institutional Review Boards (IRBs) that review federally-funded research or research conducted under the jurisdiction of FDA. Sponsor memo available regarding Aurora's AE reporting policyThe RSPP office has prepared a memo that can be downloaded and provided to sponsors outlining the AE reporting policy of the Aurora IRB. Emergency use of unapproved drugs and devicesA memo from Gail Buenger, JD, Vice President Project Management and the Chairs of the Aurora IRBs. Brown Bag Sessions regarding new IRB policies and proceduresListen to the audio taped discussions about the new policies and procedures guiding human subject research at Aurora Health Care. The information contained in these audio tapes reflects the current practice of the Aurora Research Subject Protection Program (RSPP), but may be revised in the future to meet changes in human subject protection requirements.
Problem accessing the audio files? Suggestion boxLet us know your suggestions, ideas or questions.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
 |
 |
|
 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
