SCREENING AND ENROLLMENT
Q: May we screen patients in person, or does the screening have to be done by phone?
A: You may screen patients either in-person or by phone. We presented in the training an approach to screening by phone since we think that this may be the most feasible approach at most sites. If the practices that you will work with to recruit patients prefer that you screen in person, please use that approach, mindful that we do not want the study to interfere with clinical operations. Please use the approach that works best for your site.
Q: I know that we are aiming to enroll patients around 3 months old, but can we enroll them all the way up to 11.99 months old?
A: Yes
Q: For the age 1-year visits, the protocol says that the subject needs to be between age 9 months and age 21 months at the time of the in-person visit. If we enroll a patient between 9 months and 11.99 months old, should the enrollment visit be combined with the age 1-year visit, meaning that we should obtain blood at the enrollment visit, especially if they’re already drawing it standard of care?
A: We encourage the collection of blood at the time of a scheduled clinical draw in children age 9 months or older, even if it takes place at the enrollment visit, since eligibility for an age 1-year visit (that includes a blood draw) begins at 9 months. If a participant has a clinical blood draw scheduled for months 9-11.99, please collect the study blood (0.5 ml purple top tube and at least 4.5 ml red top tube) at that time. Please order a CBC with differential, if one has not already been ordered clinically. We then ask that you time the “age 1-year visit” later for these children enrolled at age 9-11.99 months. Specifically, we would like the participant to come back at 18 months and provide all samples (blood, nasal swab, saliva swab, and stool). There should be no changes to specimen collection at the age 2-year visit (blood, nasal swab, saliva swab, and stool).
We will change the Specimen Checklist in REDCap so that one can indicate that blood was collected at the enrollment visit for these older children (ages 9-11.99 months). In the meantime, please note the blood draw and CBC with diff results in the Comments section of the Specimen Checklist. If blood is drawn during the enrollment visit, please complete a Protocol Deviation Form.
REDCap
Q: What browser should I use for filling out forms in REDCap?
A: REDCap has a tendency to freeze in Internet Explorer. We recommend that you use Mozilla Firefox or Google Chrome. If you must use Internet Explorer, please save your work frequently!
Q: Do you recommend that we use a laptop or iPad with REDCap?
A: Either a laptop or iPad will work if you have an internet connection. Please follow your hospital’s rules about encrypting mobile devices such as laptops and iPads. Please note that the interviews are meant to be administered by staff – not self-administered by the parent/legal guardian.
Q: Do we need to print case report forms (CRFs) if we are using REDCap?
A: You may wish to print blank paper CRFs to use in case of internet failure. Should you enter data directly into REDCap and need a paper CRF in the future, one can print a CRF from REDCap by downloading the specific form of interest as a PDF. The EMNet Coordinating Center does NOT need copies of any paper CRFs. Please download forms as a PDF if you need them locally.
Q: Why does an error message pop-up saying that my entry into a data form is not valid?
A: Some answer boxes are validated and will only accept an answer to a question in a certain format. For example if one tries to enter a date as 3/22 it is not be considered a valid entry. Instead, the date should be entered as 03/22/2017.
Q: What does it mean when my form is classified as either complete, unverified or incomplete?
A. You should mark a form as “complete” if data entry is complete; no additional data need to be entered. Mark the form as “unverified” if data entry is partially complete and there are fields pending responses. “Incomplete” communicates that no data have been entered.
Q: What should I do when I get an error message because I have too many tabs open in REDCap?
A: Usually, if you click the browser “Back” button, you can retrieve entered information from the cache. Then, close the other tabs and save the form again. Please be careful about having too many tabs open, as saving may not work and newly entered data lost.
SPECIMENS
Q: What do I do if a participant does not agree to the genetic testing portion of the study?
A: Consent to the genetic portion of the study is optional. A participant may decline participation in the genetic portion of the study but still be enrolled into the main study. You will indicate whether or not they consented to the genetic portion in the Screening Form. If a participant declines the genetic testing portion of the study, the blood collected from this participant will be processed in the same manner as someone who consents to genetic testing. The pellets from individuals who do not consent to genetic testing will be sent to MGH, instead of the University of Arizona.
Q: Where do I note whether or not the participant consented to the optional genetic testing?
A: After reviewing the consent form with the participant, you should return to the Screening Form and answer yes or no to whether or not consent was obtained. If yes, answer the follow-up question of whether or not the child was consented to the genetics portion of the study.
Q: Can we store blood at 4C before putting into -80C?
A: Yes. If a -80C freezer is not easily accessible or you are not able to process the blood right away, you may store the blood at 4C within 1 hour of collection. However, the blood must be processed and transferred to a -80C freezer within 24 hours of collection.
Q: Is it okay to collect the nasal swab at a visit, even if the child is sick (e.g., has upper respiratory infection)?
A: Yes. We will collect information about the child’s symptoms during the visit, which we will take into account when doing analyses of the nasal swab data.
Q: Some of the tubes of viral transport media (VTM) in my refrigerator have frozen on the mid-level setting. Is it okay to use the VTM after it has been frozen?
A: Yes, you can still use the VTM after it has been frozen.
Q: How long can the VTM be outside of the refrigerator before it becomes unusable?
A: You should avoid leaving the VTM outside of the refrigerator as much as possible. If you accidentally leave the VTM out of the refrigerator for a few hours, that is okay but anything left at room temperature for more than 2-3 days should be discarded. The VTM loses its stability after extended periods of time at room temperature.