You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
There are many factors that go into a successful clinical study start-up. Having the proper team assembled can be a critical factor in the success of any study. Choosing the right site is another factor that can make or break a successful study start-up. Having a research coordinator and principal investigator that are engaged is important too.
Topics: Study Start-up, IRB, Sponsor, Site Staff
During a routine monitoring visit of a physician-sponsored IDE study, it was noted that the site was receiving “waivers” from the Sponsor to enroll subjects who did not meet one of the anatomical exclusion criteria. A
From the FDA’s perspective, did the Sponsor do enough?
Topics: Protocol Deviations, FDA, Sponsor, Physician-Sponsored IDE Study, Clinical Monitoring
You may have heard the term Sponsor-Investigator before, but just who are they and what do they do? Just as the title suggests, a Sponsor-Investigator is someone who both initiates (sponsors) and conducts (investigator) an investigation. This may sound simple, but in actuality, the role can be quite complicated. However, like anything else, with proper preparation and support it can be accomplished. Sponsor-Investigators are a rare breed of extremely intelligent, hardworking people who are on the cutting edge of scientific advancement in their respective fields. They are so committed that they are willing to do essentially twice the work to bring new technologies and advancements to the medical community.
Topics: 21 CFR, Investigator, FDA, Sponsor
As a monitor working at a clinical research organization (CRO), we partner with sponsors who, many times, have their own internal clinical research associates (CRAs) involved with the same studies. At the very least, each sponsor has a project manager for that trial. Both the internal sponsor project manager and/or CRA and the external field CRA at the CRO want to work together to make monitoring the study as efficient and effective as possible.
Topics: Internal CRA, External CRA, Clinical Research Organization, Sponsor
At times, a Sponsor may provide a site with a memo allowing the site to enroll a patient who does not meet all inclusion or exclusion criteria. Or a Sponsor may give the site pre-approval to deviate from the protocol-defined visit windows. Is this waiver enough? Would the investigative site be covered in the event of a federal audit?
Topics: FDA, Regulations, Sponsor, Protocol Waiver
I came across an interesting article which talked about sponsor communication with an IRB. In a nutshell, it explained: Sponsor communication with IRBs has long been deemed inappropriate and since the 1980’s, sponsors having direct contact with an IRB has been frowned upon. Per Paul Goebel, president of Paul W. Goebel Consulting, Inc., a clinical research consulting firm, and former chief of CDE’s Institutional Review Branch, “When the regs were first written, some FDA officials said the communications should go through the principal investigator to keep the sponsors from bullying the IRBs and to keep IRBs safe from undue influence by the sponsors.”
Topics: Direct Communication, FDA, IRB, Sponsor