As we work our way through a review of the criteria for approval, please keep in mind that these criteria should guide our study reviews and the drafting of contingencies sent back to study teams. The second criterion for approval is “Risks to subjects are reasonable in relation to anticipated benefits, if any, and the […]
Study closure form options explained
The CLARA closure form has three options for the status of a study that you’re trying to close. The study must fit into one of these three categories to qualify for closure. “Study never initiated (sponsored studies only)” is appropriate for industry-sponsored trials that, for whatever reason, never got off the ground at this site. […]
The First Criterion for IRB Approval of Research — A Refresher
When participating in those lively, and sometimes lengthy, discussions at IRB meetings, it can be easy to forget that IRB approval is based on on just a handful of criteria. Upcoming IRB Members Blog items will provide a refresher of these criteria. These criteria should underpin all the contingencies the IRB sends back to investigators. […]
New submission form changes, plus some tips for completing the form
Those who pay close attention to these things (and we hope that’s all of you!) may have noticed some recent changes to the HIPAA section of the new submission form. The changes include rewording some queries to make it clearer that the form is asking you to indicate which specific PHI elements you are going […]
Picking the right “document type” for your informed consent material in CLARA
When uploading documents in CLARA, you’ll encounter a dropdown list of different document types. Please be careful to choose the type that matches the document you’re trying to upload. We’ve noticed that, in particular, the seven informed consent-related options tend to get selected a bit randomly. They all begin with “Consent, Assent and HIPAA;” the […]
Remember to address both data AND specimen handling in your protocol, when applicable
If your study involves keeping data and specimens for possible future research use, please remember to address the security and storage of both the data and the specimens in your protocol. We very often see what we think of as protocols with good intentions – their storage and use sections start out by mentioning both […]
Please don’t check the “attach to letter” box when drafting contingencies
When you’re drafting contingencies during your study reviews, you’ll notice an “attach to letter” box at the bottom of the contingency box, as shown here: When drafting contingencies before a meeting, please do not check “attach to letter.” Checking this box makes the draft contingency visible to the study team, even before a contingency […]
Upcoming (Feb. 5) consent process workshop offers CRS credit
We’ve all heard the saying, “Consent is a process, not a form.” An upcoming workshop at Arkansas Children’s Hospital promises an innovative look into the process of informed consent with your study subjects, and offers Certified Research Specialist (CRS) credit to boot. The first hour of this 2-hour class will review the regulations, policies, and […]
Remember, PIs can’t upload anything once a study’s assigned to an agenda
When you’re reviewing a study, you’ll sometimes notice that a submission is missing a document. Your first temptation may be to email the study team to ask them to upload the missing item. However, please keep in mind that once a study has been assigned to an agenda, PIs cannot make any more changes to […]
January 28th webinar offers CRS credit!
Do you work on studies listed on clinicaltrials.gov? If so, an upcoming class may be of interest to you – and you’ll get Certified Research Specialist (CRS) credit for attending. The Office of Research Compliance will present a webinar “Reporting Failed Trial Data: New Rules for ClinicalTrials.gov” on Wednesday, January 28, 2015, from 12:30-2:00 p.m. […]