When completing new submission forms, you’ll encounter a question that asks you to check the type of consent process(es) to be used in the research. The four response options are Assent; Parental Permission (Pediatric Consent); Informed Consent; and Requesting Waiver of Consent Process. We’ve seen some creative answers given to this question when PIs are […]

All protocols, consent forms, HIPAA authorization forms, and other study documents subject to revision should include a version number and date on each page. Whenever you update a document, please remember to update the version number and date on each page to reflect the changes. Also, when submitting tracked changes versions of documents, please make […]

An upcoming webinar on data security will offer CRS elective credit. The UAMS Office of Research Compliance is to host the PRIM&R webinar “Data Security Incidents – the Role of IRBs and Information Security” on Thursday, February 26, from 12:00-1:30 p.m. in the Walton Auditorium on the 10th floor of the Cancer Institute. An overview of […]

The TRI Translational Research Services Center offers the following free protocol development services: Reviewing and editing protocols and supporting documents prior to submission to Institutional Review Board (IRB) and other regulatory oversight bodies Provision of custom templates for research protocols, informed consent forms and other study documents Coordinating efforts of multi-disciplinary project teams during protocol […]

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. […]

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 […]

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 […]

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 […]

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 […]

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. […]