A new clinical research recruitment pamphlet has been drafted to encourage research participation at USC facilities. Would you share it with your patients and colleagues?
Comment below or send your feedback to oprs@usc.edu
Research Coordinator Bulletin
Be a Research Participant at USC : A New Pamphlet
NCI Research Consent Forms Simplified
The NCI’s consent template has been revised into a more concise forms for NCI sponsored trials. This template offers benefits in terms of shorter consents and more understandable language. If this form proves a success, USC may adopt it for all research.
Learn more: ctep.cancer.gov/protocolDevelopment/#informed_consent
New Centralized IRB Review for All Cancer Collaborative Groups
National Cancer Institute is implementing a central IRB review model in order to reduce the administrative burden on investigators and local IRBs. Under the new model, the NCI IRB will be responsible for both study review as well as review of local context considerations. USC is an early participant in the implementation process. The Health Science Campus IRB and Norris Clinical Investigations Support Office (CISO) will lead USC investigators through this transition.
Synopsis of the Central IRB model
More about NCI Central IRB
What Keeps YOU Up at Night? #2 : Reportable Events
Q: What’s a reportable event? Is that different from a protocol deviation?
A: The term “Reportable Event” is usually used to refer to “Adverse Events” and “Unanticipated Problems Involving Risks to Subjects or Others”.
- Adverse Events (AEs) are unexpected, related or possibly related events, and are either serious or place subjects or others at a greater risk of harm than was previously known or recognized .
- Unanticipated Problems Involving Risks to Subjects or Others (UPX / UPIRSO) include any incident, experience, or outcome that meets all of the following criteria:
- unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
- Protocol deviation refers to those occasions when protocol required procedures are accidentally or intentionally not met. There is no regulatory language that defines those that meet the level of required reporting.
Q: I heard a study subject complained to hospital administration that they were denied $25 study compensation because the study coordinator was unable to draw blood from the subject. Is this a reportable event? why?
A: Providing $25 was a condition of research participation. The research team’s inability to draw blood from a particular subject does not negate the subject’s participation. The situation qualified as a reportable event and was brought to the attention of the IRB. A meeting was held with the PI and the study coordinator. It was determined that the coordinator had erred by not compensating the subject. It was also noted that the coordinator had foreign medical training but was unlicensed to practice in California and was subsequently terminated. Both of these issues should be noted for all payment denials and unlicensed MDs serving as coordinators.
The Power of One More Patient – Free Webinar
DATE: Wednesday, May 15th | 10 am (PST)
TOPIC: The Power of One More Patient: How Effective Patient Recruitment Strategies Can Translate into Millions in Additional Revenue and Positively Impact Your Site
REGISTER HERE: www.huronconsultinggroup.com
DESCRIPTION:
Gone are the days of passive approaches to recruitment and enrollment. This session will bring together expertise of two seasoned professionals to help site personnel actively engage and lead discussions around recruitment and enrollment, and demonstrate why an active approach is critical to success. Learning objectives include: recruitment planning and enrollment management, explain how and why two-way recruitment conversations should occur between sites and sponsors prior to study start-up to ensure recruitment success.
Sunshine Act Will Impact Research
The new law represents federal efforts to bring to light potential conflicts of interest between physicians and industry. The Sunshine Act requires manufacturers of covered drugs, devices, biological products, and medical supplies to annually report payments/ financial ties to physicians, researchers and teaching hospitals.
USC Cancer Center Coordinators Invited to Serve on Quality Assurance Committee
The Quality Assurance and Monitoring Committee (QAMC) at Norris Cancer Center will be inviting Study Coordinators and Data Manager(DM) to serve on the QAMC as members for a one year period. Their input will strengthen the Committee by providing an point of view from ‘the trenches’ . Coordinators and DMs at the Cancer Center have always been involved in auditing investigator initiated or CTEP trials for the QAMC. The auditing process represents a valuable educational tool for the research community.
Professor Fired Over Questionable Spending
Mr. Chaudhuri was regarded as an academic star at McGill, where he held a prestigious professorship. But auditors raised questions about travel and research expenses he had charged to the university…The auditors…uncovered roughly $159,000 in improper spending.
iStar: IRB Application Upgraded
Version 3.2 | April 20, 2013
The online IRB application system has recently been revised. To improve submission and review, the amendments applications have been unified into a single application form. There is now only ONE form that combines both the amendment and the editable copy of the study. The amendment potion shows up prior to the study form pages. The questions on enrollment and informing subjects of changes have been moved to amendment page 5.
New Clinical Trials Office coming soon
The new Clinical Trials Office (CTO) will be responsible for budgeting, contracting, business development and Medicare coverage analysis at USC. The announcement was made by Randy Hall, Vice President of Research.