The IRB may require you to put information in the consent form describing how subject data will be stored. If you are storing all data with only a code rather than direct identifiers, you should include consent language saying something like, “Your personal information will be identified only with a code and will not include anything […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
“Retrospective Chart Review” defined
When we see a study submission that describes a project as a retrospective chart review, the IRB needs to make sure the project is truly retrospective. A retrospective chart review involves looking at information that already exists at the time of IRB approval. We may ask that you specify an end date to document that all the […]
New blog quiz available — earn 0.5 CRS credits
The next IRB blog quiz is available at learnondemand.org. To find the quiz, go to the learnondemand.org home page and type “IRB” in the search box at upper right. Remember, these quizzes allow you to earn 0.5 Certified Research Specialist elective hours each – up to 2 hours per year – at the time and place […]
Students (and their faculty advisors): Remember to close completed studies in CLARA
So your study is done, your dissertation is written, and you’re gearing up for graduation and bigger and better things now that you’ve completed this part of your education. It’s a busy and exciting time for you, we know, but we do have one last piece of research-related advice for you – you’re not really out […]
Please Excuse My Dear Aunt Sally — She can only understand a lay summary that’s written in plain language
The CLARA new submission form includes a question asking “What is the lay summary of this study?” When we say “lay summary,” we mean “lay summary.” As the help text indicates, this response should be written in simple, non-technical vocabulary at a no-greater-than-high-school level. Cutting and pasting text from the study summary in your informed […]
Remember, we can’t approve studies until CITI training is current
Well, you may recall the good news from a few weeks back – the required human subject protection training taken through citiprogram.org is now valid for 3 years, instead of the previous 2 years. The not-so-good news is that we still need to have all study staffers’ CITI training current before we can approve a […]
CRS certification holders — we need your opinion!
We’re asking everyone who has completed the Certified Research Specialist program to give us some feedback about the CRS curriculum. Please click on our SurveyMonkey link to share your opinions about the program. We’d like to get more information about what you think the program’s strengths and weaknesses are to help evaluate the overall program. We’re […]
New questions on CLARA new submission form
You may notice some new questions on the new submission form in CLARA. We’ve added some questions related to the use of external IRBs. If your study will undergo its primary review by an outside IRB, click “yes” to the “are you requesting use of an external IRB” query. The next question will ask for […]
CITI training now valid for three years
If you thought you heard the angels singing today, your ears weren’t playing tricks on you – they really were singing (the angels, not your ears). Why? Because the required human subject protection training taken online at citiprogram.org is now valid for three years, up from the previous two years. That means you and your […]
ACH employees and CLARA
Attention all Arkansas Children’s Hospital (ACH) staffers who use CLARA: CLARA is able to accommodate a change to an ACH email address! Reliable sources who work in ACH compliance tell us that ACH staffers are in the process of transitioning to ACH email addresses, which will be used instead of uams.edu addresses. CLARA automatically defaults […]